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DIAGNOSTIC PILOT STUDY OF AN EVALUATION SCALE OF THE REVERTION SYMPTOMS AFTER
AN ANTERIOR RESECTION OF THE RECTUM
Gaetano Militello (Ostomy Care Nurse, Wound Care Expert, U.S.L. 4, Misericordia e Dolce Hospital, Prato – Italy)
Mario Antonini (Ostomy Care Nurse, Wound Care Expert, U.S.L. 11, San Giuseppe Hospital, Empoli – Italy)
Sonia Fligor (Nurse, University of Florence – Italy)
Cristina Lippi (Nurse, U.S.L. 4, Misericordia e Dolce Hospital, Prato – Italy)
Giuliano Quaresimini (Surgeon Assistant, Misericordia e Dolce Hospital, Prato – Italy)

                                                                                                                                                                                                        Drug treatment for fecal incontinence in     • Numero di persone che non
INTRODUCTION                                                                                                                                                                                            adults By: Cheetam, Mark J, Brazzelli,
                                                                                                                                                                                                        Miriam, Norton, Christine C, Glazener,
                                                                                                                                                                                                                                                     raggiungono una completa continenza
                                                                                                                                                                                                                                                     • Numero di persone che non migliora
The pilot study objective is to validate a scale for secondary symptoms of the revertion after the                                                                                                      Cathryn MA, Cochrane Database of
                                                                                                                                                                                                        systematic Reviews, Issue 4.
                                                                                                                                                                                                                                                     • Frequenza dell’incontinenza (diario o
                                                                                                                                                                                                                                                     self-report)
anterior rectum resection. As this problem seems to be scarcely evaluated in a correct scientific                                                                                                                                                    • Grado di incontinenza (ad esempio, il
                                                                                                                                                                                                                                                     peso delle feci)
way. A systematic bibliographical research highlighted that also the Cochrane shows two aspects:                                                                                                                                                     • Valutazione incontinenza
                                                                                                                                                                                                                                                     • Episodi di urgenza fecale
ano-rectal physiologic measurements are not directly comparable among different studies                                                                                                                                                              • Misurazioni fisiologiche anorettali

because of the huge variability of the technology and the evaluation methods of the ano-rectal
function used by different centers. Moreover they cannot be directly connected to the clinical                                                                                                          Electrical   stimulation     for     fecal   SINTOMI DEL PAZIENTE:
                                                                                                                                                                                                        incontinence in adults By: Hosker G, Cody    - Incontinenza descrizione
outcomes. For these reasons such measurements should be considerate as substitute endpoints.                                                                                                            JD, Norton CC, Cochrane Database of          - Frequenza dell’incontinenza
                                                                                                                                                                                                        Systematic Reviews, Issue 4.                 - Punteggio incontinenza (non viene
According to any research guidelines, indication from the research a standard related to the                                                                                                                                                         definito come misurarla)
                                                                                                                                                                                                                                                     - Verificarsi di effetti negativi
outcomes of the intestinal function should be defined to facilitate the comparison among                                                                                                                                                             Misurazioni della fisiologia anorettale.

different studies of different rehabilitation techniques.


                                                                                                                                                                                                        Plugs for containing faecal incontinence     SINTOMI DEL PAZIENTE:
                                                                                                                                                                                                        By: Deutekom M, Dobben A, Cochrane           - La frequenza di incontinenza delle feci
                                                                                                                                                                                                        Database of Systematic Reviews, Issue 4.     o flatus (diario o self-report)
                                                                                                                                                                                                                                                     - Grado di incontinenza (ad esempio, il
                                                                                                                                                                                                                                                     peso delle feci)
METHODS AND MATERIALS                                                                                                                                                                                                                                VALUTAZIONE INCONTINENZA:
                                                                                                                                                                                                                                                     - Episodi di urgenza anale.
A diagnostic blind research has been done to define the following essential data of the test:                                                                                                                                                        MISURE FISICHE:
                                                                                                                                                                                                                                                     - Realizzazione di pseudo-continenza
- Accuracy;                                                                                                                                                                                                                                          (continenza solo mentre indossa un
                                                                                                                                                                                                                                                     tampone)
- Reproducibility.                                                                                                                                                                                                                                   - Per quanto tempo lo indossa e
                                                                                                                                                                                                                                                     frequenza d’uso
In case of lack of any other bibliographical indications, the clinical evaluation should be considered                                                                                                                                               - Tasso di perdita
                                                                                                                                                                                                                                                     - Controllo degli odori.
the gold standard.
                                                                                                                                                                                                        Reconstructive Techniques after Rectal       - Numero di movimenti intestinali al
                                                                                                                                                                                                        Resection for Rectal Cancer By: Carl J,      giorno.
                                                                                                                                                                                                        Brown, Fenech, Darlene, McLeod, Robin S,     - Urgenza, definita come l’incapacità di
                                                                                                                                                                                                        Cochrane Database of Systematic Reviews.     rimandare la defecazione.
                                                                                                                                                                                                                                                     - L’incontinenza fecale, misurata da uno
                                                                                                                                                                                                                                                     strumento adeguato (non vengono
                                                                                                                                                                                                                                                     definite le scare che possono essere
                                                                                                                                                                                                                                                     considerate adeguate.
Patients were selected from colo-proctological centers of Prato and Empoli USL (Local Sanitary                                                                                                                                                       - L’evacuazione incompleta, definita
                                                                                                                                                                                                                                                     dalla sensazione di tenesmo residua dopo
Units).                                                                                                                                                                                                                                              la defecazione.
                                                                                                                                                                                                                                                     L’uso di farmaci anti-diarrea, definito
INCLUSION CRITERIA                                                                                                                                                                                                                                   come la continua dipendenza da farmaci
                                                                                                                                                                                                                                                     costipativi.
The patients involved have had a revertion surgery after anterior resection of the rectum and they                                                                                                      Bilateral sacral spinal nerve rectum         -          Frequenza         episodi      di
were all out-patients.                                                                                                                                                                                  resection . Matzel KE, Stadelmaier U,
                                                                                                                                                                                                        Bittorf B, Hohenefellner, Hohenfellner       -
                                                                                                                                                                                                                                                          inocntinenza
                                                                                                                                                                                                                                                                Soddisfazione del paziente (non
EXCLUSION CRITERIA                                                                                                                                                                                                                                   -
                                                                                                                                                                                                                                                          specificato come valutata)
                                                                                                                                                                                                                                                                Manometria       (pressione    di
Patients that had a different type of resection; patients that were not reversed, patients that had                                                                                                                                                       compressione, pressione a riposo,
                                                                                                                                                                                                                                                          soglie per la prima percezione,
not been followed by the mentioned centers, patients with privious fecal incontinence for                                                                                                                                                            -
                                                                                                                                                                                                                                                          massimo volume tollerabile
                                                                                                                                                                                                                                                                Cleveland    Clinic    Continence
different reasons than the ones takent into consideration in this study;, patients that used drugs                                                                                                                                                        Score.


that can cause fecal incontinence or severe disorders of the intestinal alvum. Sample units: 20
patients.                                                                                                                                                                                               Kaspar Z’graggen, Christoph A. Maurer,       - Frequenza dei movimenti intestinali
                                                                                                                                                                                                        Stefan Birrer, Daniel Giachinoi, Beatrice    nelle 24 ore (range)
                                                                                                                                                                                                        Kem MD, Markus W, Buchler, A new             - Urgenza
                                                                                                                                                                                                        surgical Concept for Rectal Replacement      - Frammentazione delle feci
                                                                                                                                                                                                        aftewr low anterior resection. The           - Incontinenza (non viene indicata la
                                                                                                                                                                                                        transverse Coloplasty Pouch Annals of        modalità di valutazione.
                                                                                                                                                                                                        Surgery Vol. 234, N. 6, 780-2001 Lippicott
                                                                                                                                                                                                        Williams & Williams % Wilins, Inc.




 RESULTS
 In order to evaluate the validiy of the scale we firstly gave a definition of Cut-off levels by
 comparing the evaluation results of the scale with the data of the clinical evaluation done by the                                                                  PRATO EVALUATION SCALE
 clinician and by elaborating matrix tables regarding to each cut-off value. The scale presented                                                  INCONTINENCE                                                          OTHER SYMPTOMS
 two Cut-Offs: the first (light-medium) the second (medium-severe). Then sensitivity, specificity,
                                                                                                           DATE
 Vp+, Vp-, LR+, LR- have been evaluated. The evaluation of the Cut-Off was done using the                            Flatulence          Liquid Stools     Solid Stools      Bloating        Bleeding                  Rectal                            Pain                    Perineal
 Youden Index.                                                                                                                                                                                                         spasm                                                     Lesions
 The evaluation of the reproducibility was done through the K of Choen. K of Choen of 92% shoul                       SF          R          SF       R     SF        R                 Trace        True                                  Weak                Strong
 be considered as remarkable reproducibility.                                                            SOMETIME     1           2          3        5      6        8         1        1              2                   2                  1                    2             Present
 As there are several other scales to measure incontinence, the values of their validation have                                                                                                                                                                                      4
 been searched in order to compare them with the section of the Prato scale section regarding              DAILY      6           5          7        9     10       12         2        3              5                   5                  3                    5                 No
 the incontinence. This was done to understand if the use of a single scale is correct or if it’s                                                                                                                                                                                   lesion
 better to evaluate the incontinence with another scale and the other symptoms with this scale if                                                                                                                                                                                      0
 we should use this scale only.                                                                           ABSENT            0                     0              0              0               0                           0                             0
 A systematic bibliographical research has given unexpeted results, as the validation of the              TOTAL
 above-mentioned scales was done just for some of them; moreover, in those cases, only the
                                                                                                         Signature
 agreement among helth care professionals was considered.
 No data about sensitivity and specificity were.
 In a study R of Parson was evaluated to demonstrate a connection between scale values and
 clinical data, but the same Chocrane stated that this index tent to overestimate the real value.
                                                                                                                                                          Cut-off

                                                                                                                     VN                                                             VP
DISCUSSION                                                                                                           lieve                                                          media                                VP
The pilot study seems to show positive results but reproducibility must be held under control in                                                                                                                         grave
case of:
- Other valuators will be involved
- The sample selection includes more patients with light symptomatology.
This research is also oriented to start the validation of the scale about to the incontinence, as it’s
the only study conducted with a methodology suggested by Cochrane, also for this the preliminary
results are good.                                                                                            0                                                       7                           16                                                      38
                                                                                                                                                                          valore di cut-off
                                                                                                                                                                                    cut-




      Cut-off 16                    Valore                                     I.C. 95%                                         Cut-off 7                            Valore                                                     I.C. 95%
      Sensibility                    0,83                         0,661                       1,005                             Sensibility                          1,000                            1,000                                                    1,000
      Specificity                    0,91                         0,788                       1,029                             Specificity                           0,94                            0,849                                              1,02196623
         VPP                         0,88                         0,729                       1,035                                   VPP                             0,82                          0,59025087                                           1,04611277
         VPN                         0,87                         0,731                       1,007                                VPN                                1,00                          1,00000000                                           1,00000000
         LR +                        9,17                         2,406                       34,919                               LR +                              15,50                          4,05667414                                           59,22339135
         LR -                        0,18                         0,064                       0,369                                   LR -                            0,00
      Accuracy                       0,450                                                                                      Accuracy                              0,95
    Prob. Pre-test                   0,818                                                                                 Prob. Pre-test                            0,225
    (prevalence)                                                                                                           (prevalence)
    Pre-test odds                    7,500                                                                                 Pre-test odds                             0,290
   Post –test odds                   0,882                                                                                 Post –test odds                           4,500
   Prob. Post-test                   0,450                                                                                 Prob. Post-test                           0,818

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Diagnostic pilot study of an evaluation scale - 11th ECET Congress Bologna 2011

  • 1. DIAGNOSTIC PILOT STUDY OF AN EVALUATION SCALE OF THE REVERTION SYMPTOMS AFTER AN ANTERIOR RESECTION OF THE RECTUM Gaetano Militello (Ostomy Care Nurse, Wound Care Expert, U.S.L. 4, Misericordia e Dolce Hospital, Prato – Italy) Mario Antonini (Ostomy Care Nurse, Wound Care Expert, U.S.L. 11, San Giuseppe Hospital, Empoli – Italy) Sonia Fligor (Nurse, University of Florence – Italy) Cristina Lippi (Nurse, U.S.L. 4, Misericordia e Dolce Hospital, Prato – Italy) Giuliano Quaresimini (Surgeon Assistant, Misericordia e Dolce Hospital, Prato – Italy) Drug treatment for fecal incontinence in • Numero di persone che non INTRODUCTION adults By: Cheetam, Mark J, Brazzelli, Miriam, Norton, Christine C, Glazener, raggiungono una completa continenza • Numero di persone che non migliora The pilot study objective is to validate a scale for secondary symptoms of the revertion after the Cathryn MA, Cochrane Database of systematic Reviews, Issue 4. • Frequenza dell’incontinenza (diario o self-report) anterior rectum resection. As this problem seems to be scarcely evaluated in a correct scientific • Grado di incontinenza (ad esempio, il peso delle feci) way. A systematic bibliographical research highlighted that also the Cochrane shows two aspects: • Valutazione incontinenza • Episodi di urgenza fecale ano-rectal physiologic measurements are not directly comparable among different studies • Misurazioni fisiologiche anorettali because of the huge variability of the technology and the evaluation methods of the ano-rectal function used by different centers. Moreover they cannot be directly connected to the clinical Electrical stimulation for fecal SINTOMI DEL PAZIENTE: incontinence in adults By: Hosker G, Cody - Incontinenza descrizione outcomes. For these reasons such measurements should be considerate as substitute endpoints. JD, Norton CC, Cochrane Database of - Frequenza dell’incontinenza Systematic Reviews, Issue 4. - Punteggio incontinenza (non viene According to any research guidelines, indication from the research a standard related to the definito come misurarla) - Verificarsi di effetti negativi outcomes of the intestinal function should be defined to facilitate the comparison among Misurazioni della fisiologia anorettale. different studies of different rehabilitation techniques. Plugs for containing faecal incontinence SINTOMI DEL PAZIENTE: By: Deutekom M, Dobben A, Cochrane - La frequenza di incontinenza delle feci Database of Systematic Reviews, Issue 4. o flatus (diario o self-report) - Grado di incontinenza (ad esempio, il peso delle feci) METHODS AND MATERIALS VALUTAZIONE INCONTINENZA: - Episodi di urgenza anale. A diagnostic blind research has been done to define the following essential data of the test: MISURE FISICHE: - Realizzazione di pseudo-continenza - Accuracy; (continenza solo mentre indossa un tampone) - Reproducibility. - Per quanto tempo lo indossa e frequenza d’uso In case of lack of any other bibliographical indications, the clinical evaluation should be considered - Tasso di perdita - Controllo degli odori. the gold standard. Reconstructive Techniques after Rectal - Numero di movimenti intestinali al Resection for Rectal Cancer By: Carl J, giorno. Brown, Fenech, Darlene, McLeod, Robin S, - Urgenza, definita come l’incapacità di Cochrane Database of Systematic Reviews. rimandare la defecazione. - L’incontinenza fecale, misurata da uno strumento adeguato (non vengono definite le scare che possono essere considerate adeguate. Patients were selected from colo-proctological centers of Prato and Empoli USL (Local Sanitary - L’evacuazione incompleta, definita dalla sensazione di tenesmo residua dopo Units). la defecazione. L’uso di farmaci anti-diarrea, definito INCLUSION CRITERIA come la continua dipendenza da farmaci costipativi. The patients involved have had a revertion surgery after anterior resection of the rectum and they Bilateral sacral spinal nerve rectum - Frequenza episodi di were all out-patients. resection . Matzel KE, Stadelmaier U, Bittorf B, Hohenefellner, Hohenfellner - inocntinenza Soddisfazione del paziente (non EXCLUSION CRITERIA - specificato come valutata) Manometria (pressione di Patients that had a different type of resection; patients that were not reversed, patients that had compressione, pressione a riposo, soglie per la prima percezione, not been followed by the mentioned centers, patients with privious fecal incontinence for - massimo volume tollerabile Cleveland Clinic Continence different reasons than the ones takent into consideration in this study;, patients that used drugs Score. that can cause fecal incontinence or severe disorders of the intestinal alvum. Sample units: 20 patients. Kaspar Z’graggen, Christoph A. Maurer, - Frequenza dei movimenti intestinali Stefan Birrer, Daniel Giachinoi, Beatrice nelle 24 ore (range) Kem MD, Markus W, Buchler, A new - Urgenza surgical Concept for Rectal Replacement - Frammentazione delle feci aftewr low anterior resection. The - Incontinenza (non viene indicata la transverse Coloplasty Pouch Annals of modalità di valutazione. Surgery Vol. 234, N. 6, 780-2001 Lippicott Williams & Williams % Wilins, Inc. RESULTS In order to evaluate the validiy of the scale we firstly gave a definition of Cut-off levels by comparing the evaluation results of the scale with the data of the clinical evaluation done by the PRATO EVALUATION SCALE clinician and by elaborating matrix tables regarding to each cut-off value. The scale presented INCONTINENCE OTHER SYMPTOMS two Cut-Offs: the first (light-medium) the second (medium-severe). Then sensitivity, specificity, DATE Vp+, Vp-, LR+, LR- have been evaluated. The evaluation of the Cut-Off was done using the Flatulence Liquid Stools Solid Stools Bloating Bleeding Rectal Pain Perineal Youden Index. spasm Lesions The evaluation of the reproducibility was done through the K of Choen. K of Choen of 92% shoul SF R SF R SF R Trace True Weak Strong be considered as remarkable reproducibility. SOMETIME 1 2 3 5 6 8 1 1 2 2 1 2 Present As there are several other scales to measure incontinence, the values of their validation have 4 been searched in order to compare them with the section of the Prato scale section regarding DAILY 6 5 7 9 10 12 2 3 5 5 3 5 No the incontinence. This was done to understand if the use of a single scale is correct or if it’s lesion better to evaluate the incontinence with another scale and the other symptoms with this scale if 0 we should use this scale only. ABSENT 0 0 0 0 0 0 0 A systematic bibliographical research has given unexpeted results, as the validation of the TOTAL above-mentioned scales was done just for some of them; moreover, in those cases, only the Signature agreement among helth care professionals was considered. No data about sensitivity and specificity were. In a study R of Parson was evaluated to demonstrate a connection between scale values and clinical data, but the same Chocrane stated that this index tent to overestimate the real value. Cut-off VN VP DISCUSSION lieve media VP The pilot study seems to show positive results but reproducibility must be held under control in grave case of: - Other valuators will be involved - The sample selection includes more patients with light symptomatology. This research is also oriented to start the validation of the scale about to the incontinence, as it’s the only study conducted with a methodology suggested by Cochrane, also for this the preliminary results are good. 0 7 16 38 valore di cut-off cut- Cut-off 16 Valore I.C. 95% Cut-off 7 Valore I.C. 95% Sensibility 0,83 0,661 1,005 Sensibility 1,000 1,000 1,000 Specificity 0,91 0,788 1,029 Specificity 0,94 0,849 1,02196623 VPP 0,88 0,729 1,035 VPP 0,82 0,59025087 1,04611277 VPN 0,87 0,731 1,007 VPN 1,00 1,00000000 1,00000000 LR + 9,17 2,406 34,919 LR + 15,50 4,05667414 59,22339135 LR - 0,18 0,064 0,369 LR - 0,00 Accuracy 0,450 Accuracy 0,95 Prob. Pre-test 0,818 Prob. Pre-test 0,225 (prevalence) (prevalence) Pre-test odds 7,500 Pre-test odds 0,290 Post –test odds 0,882 Post –test odds 4,500 Prob. Post-test 0,450 Prob. Post-test 0,818