Mdm jeddah 1

Haemostasis, sealing and adhesion prevention
in Gynecology and Obstetrics
Prof. Dr. med. Michael D Mueller
Universitätsklinik für Frauenheilkunde

michel.mueller@insel.ch
Universitätsklinik für Frauenheilkunde, Inselspital Bern
Bleeding and vessel sealing in Obstetrics and Gynecology, Jeddah 9.12.12 2

 Are sometimes difficult in surgery
 Life threatening bleeding is not seldom in OBGYN
 Insufficient haemostasis
 may contribute to postoperative morbidity and mortality
 adhesion formation
Haemostasis and vessel sealing

Adhesions
 Adhesions may cause:
• Re-hospitalisation
• Dyspareunia
• Chronic pelvic pain
• Intestinal obstruction
• Chronic fatigue
• Infertility
 Prevention of adhesions (de novo or by re-formation) 
challenging surgical problem
 TachoSil® is an efficacious and safe local haemostatic
and helps to prevent adhesions

What is TachoSil®?
Coatet with human
• Fibrinogen 5.5 mg / cm2
• Thrombin 2.0 IU / cm2
• Riboflavin (yellow to mark
the active side)
Sponge
• Equine collagen

Fibrin-
Monomer
Fibrin-Polymer
Principles of Action
Tissue
Vlies
Thrombin
Faktor IIa
Fibrinogen
Faktor I
Strong TachoSil®-
Tissue connection

Animal model: TachoSil® applied on a liver
Cryofixation and SEM-photo after 15 minutes
Liver
parenchyma
Fibrin clot
Closer view after 15 min.  stringy
structure of the fibrin clot

Characteristics – tissue integration
Progressive biologic tissue integration
 Endogenous Fibrin  metabolic elimination
 Collagen  granulation tissue (few cells, rich
in collagen fibers)
 after 24 weeks nearly no remnants
4 W postop. 12 W postop.
TachoSil®
remnants

General indications
Hämostase
• Parenchymatöse Organe
• Sämtliche Weichteile, Hals,
Extremitäten
• Thorakal und abdominal
• Nach Lymphadenektomie
• Lungen, Darm, parenchymatöse
Organe
• Induratio Penis Plastica
Adhesion prevention
• Microsurgery
• Myoma
Haemostasis
•Parenchymatous organs
•Soft tissues in general, neck,
extremities
•Thoracic surgery and
abdominal surgery in general
Sealing
• After lymphadenectomy
• Lungs, bowel,
parenchymatous organs
• Bladder

Collagen fleecebound fibrin sealant is not associated with an
increased risk of thromboembolic events or major bleeding after its
use for haemostasis in surgery: a prospective multicentre
surveillance study. Birth M et al. (2009)
Prospective multicenter study (12 European countries)
Study focused on the occurrence of thromboembolic events, major
bleeding & immunologic events (hypersensitivity incl anaphylaxis) during
first 6 months after surgery
124 adverse events in 3098 patients receiving TachoSil® :
46 (1.5%) thromboembolic events
62 (2.0%) major bleeding events
8 (0.3%) immunologic events
Group of gynecologic surgery: no thromboembolic or immunologic
events 1 major bleeding event

TachoSil® – established & well documented
Number of studies /
surgical specialisation
Visceral surgery 11
Vascular surgery 14
Gynecol incl. Breast 5
Neurosurgery 4
Thoracic 11
Urology 7
Others 4
Basic science 27
Review 25
Number of studies /
country
Japan 22
Germany 20
Austria 12
USA 11
England 8
Others 30
Multicenter 5
Total 108
Study design
Review 27
Basic science 27
Cohort 19
Case Reports 17
RCT 10
Comparative 8
Total 108

Osada H. et al (1999)
Diagnosis
n
Patients
Myoma 12
Cervical cancer 1
Endometrium cancer 1
Adenomyosis and
benigne ovarian
tumor 1
Tubal infertility 1
Durchgeführte
Prozeduren
Anzahl
Patienten
Myomectomy 10
Radical hysterectomy 2
Simple hysterectomy 2
Microsurgery of the
tubes 1
Ovarial cystectomy 1
Retrospective case series from Japan, 4 centres

TachoSil® in Obstetrics and Gynecology
Santulli P. et al (2011)

C-section and diffuse Bleeding of the uterine scar

Postpartum Hemorrhage (PPH)
Anticipate the danger !!!!

Risk factor Odds Ratio (95% CI)
retained placenta 3.5 (2.1 - 5.8)
failure to progress during the second
stage of labor
3.4 (2.4 - 4.7)
placenta accreta 3.3 (1.7 - 6.4)
lacerations 2.4 (2.0 - 2.8)
instrumental delivery 2.3 (1.6 - 3.4)
large for gestational age (LGA)
newborn
1.9 (1.6 - 2.4)
hypertensive disorders 1.7 (1.2 - 2.1)
induction of labor 1.4 (1.1 - 1.7)
augmentation of labor with oxytocin 1.4 (1.2 - 1.7)
Obesity
Risks for Postpartum Hemorrhage (PPH)
“4 T’ s” as a mnemonic: tone, tissue, trauma, and thrombosis
Sheiner E et al. (2005)

Vaginal- or cervical tears 1:8
Atony of the uterus 1:100
Retained placenta 1:2300
Placenta accreta etc. 1:2500
Inversio uteri 1:6400
Stanco et al. 1993; AJOG
 Hysterectomy
20%
45%
Reasons for PPH

Abu Dhabi 1997
Bristol 1988
Dublin 1990
Hinchingbrooke 1998
Total
1 100.1
Prendiville W et al. BJOG 1988
Cochrane Database 2003
Reduction > 40%
Transfusions
Anaemia
PPH Prophylaxis
Active management of the third stage of labor:
 intramuscular administration of 10 IU of oxytocin
 controlled cord traction
 fundal massage after delivery of the placenta
substantially reduces the risk of PPH

 Initial general management
administration of oxytocin, emptying the urinary bladder, fluid
replacement, examination of birth canal and placenta

 Specific management for uterine atony
uterotonic drugs, uterine massage, bimanual compression of
the uterus (external or internal),
 Specific management for genital lacerations
repair of genital lacerations, hemostatics, compression
 Specific management for retained placenta
manual removal
 Continued management
until the woman reaches the appropriate facility or the
appropriate provider: anti-shock garment, IV perfusion,
“walking” blood bank
First line treatment of PPH

500-1000ml
10-15%
1000-1500ml
15-25%
1500-2000ml
25-35%
none
Palpitations
Tachycardia
BP change
Symptoms
Slight fall
(80-100mmHg)
Weakness
Sweating
Tachycardia
Marked fall
(70-80mmHg)
Restlessness
Pallor
oliguria
Clinical findings in postpartum haemorrhage
Degree of shock
2000-3000ml
35-45%
moderatecompensate mild severe
Profound fall
(50-70mmHg)
Collapse
Air hunger
anuria
Blood loss
Go to the OR

Second line
Surgery
Embolisation
rFactor VIIa
(NovoSeven®)
Tamponade

Second line
Tamponade
„Tamponade Test“
Condous et al. Obstet Gynecol 2003
Sengstaken-Blakemore-Catheter
Linton-Catheter
Foley-Catheter (several!)
Gaze-Tamponade
„Kondome“-Catheter
Bakri-Catheter
70-300ml
"When blood is flowing in rivers, it will make
packers out of non-packers in a hell of a hurry!„
Horger E. AJOG 1993
Vaginal delivery

Atony 4 weeks after delivery !!
No retained placental material

B-Lynch C. BJOG 1997
Ferguson JE. Obstet Gynecol 2000
Hayman RG Obstet Gynecol 2002
Manidip P. el al J Obstet Gynaecol Res 2003
Atony (when the bleeding is reduced after compression of the uterus)
B-Lynch-Suture

Allam MS et al. Int J Gynaecol Obstet 2005
Ghezzi et al. Hum Reprod 2007
Multiple compression sutures

TachoSil® in obstetrics for
 Oozing hemorrhages
 Bleeding from the stitches

Perreira-Technique

92917 238 (0.3%) 12 (5%)
Pl accreta
(n,% praevia)
0
Prior CS
Total
women
Pl praevia
(n,%)
3820
850
29
1
2
>3
3 183
125 (0.65%)
15 (1.8%)
3 (10%)
5 (3%)
6 (24%)
7 (47%)
2 (67%)
2 (40%)
Clark O et al. Obstet Gynecol 1985
Placenta accreta, in- or percreta

 Bleeding from the lower part of the uterus
 Risk of hysterectomy preop discussed with
the patient
 Prepared team with experienced surgeons
Placenta praevia

„low“ compression sutures
Placenta previa (bleeding from the lower part of the uterus!)
Cave: occlusion of the cervical canal

1
2
3
4
Blader

Placenta percreta

Successful continuation of pregnancy after repair of a
midgestational uterine rupture with the use of a fibrincoated
collagen fleece (TachoComb®) in a primigravid
woman with no known risk factors. Shirata I et al. (2007)
 30-year-old Japanese primigravid woman presented at 24 2/7 gw
 Past medical history noncontributory & antenatal care uneventful
 No uterine contractions or history of recent abdominal trauma
 Emergency laparotomy  partial uterine rupture of ~ 3 cm in the
right posterior wall of the uterine fundus
 Uterine rupture sutured  sufficient hemostasis could not be
obtained  TachoComb®
 Cesarean section at 35 2/7 gw

TachoSil® can be used in laparoscopic surgery
Preparation
• Compress the TachoSil®
• Roll the piece, yellow side
outside
Introduction
• Open the trocar
• Go through the upper part of
the trocar and grab the
TachoSil®
• The trocar has to be dry!

Myomas  surgical challenge for adhesions &
bleeding

Adhesions after myomectomy
Dubuisson JB 1998
155 41 % 19 %
81 98 % 82 %

Adhesions after myomectomy
More frequent in posterior myomas
Usually located at the site of the suture
More frequent with simultaneous surgery (e.g. ovary)
The size of the myoma does not play a role!

TachoSil® as bleeding and adhesion prevention

Endometrioma: strategies for adhesion prevention
1) Careful surgical procedure
( better no surgery than bad surgery !)
2) Application of barier agents
3) Pharmacologic interventions
4) Adjuvant therapy to avoid recurrence

Surgical strategies for adhesion prevention
• Cutting
• Surgical denudation
• Ischemia
• Dessication & abrasion
peritoneal trauma
healing process = mesothelial
regeneration and fibrosis
adhesions between the damaged
serosal surfaces
TachoSil® dissolves gradually and
might be used to prevent adhesions

a. Carefully handle tissue with field enhancement (magnification)
techniques
b. Focus on planned surgery and, if any secondary pathology is
identified, question the risk: benefit ratio of surgical treatment before
proceeding
c. Perform diligent haemostasis and ensure diligent use of cautery
d. Reduce cautery time and frequency and aspirate aerosolised tissue
following cautery
e. Excise tissue—reduce fulguration
f. Reduce duration of surgery, risk of infection, drying of tissues
g. Use frequent irrigation and aspiration in laparoscopic and laparotomic
surgery when needed
h. Limit use of sutures and choose fine non-reactive sutures
Good surgical technique is fundamental to any adhesion reduction
strategy:
De Wilde RL et al. (2012)

i. Avoid foreign bodies when possible—such as materials with loose
fibres
j. Avoid non-peritonised implants and meshes
k. Minimal use of dry towels or sponges in laparotomy
l. Use starch- and latex-free gloves in laparotomy
m. Reduce pressure and duration of pneumoperitoneum in laparoscopic
surgery
De Wilde RL et al. (2012)

Stripping and TachoSil®

TachoSil® in acute bleeding

Deep conization, pelvic Lymphonodectomy

TachoSil® as lymphocyst prevention?

Prevention of Lymphocele in Female Pelvic Lymphadenectomy by a
Collagen Patch Coated With the Human Coagulation Factors: A
Pilot Study. Tinelli A. et al. (2011)
Randomized in 2 groups: 1 = standard technique plus TachoSil® (n = 30)
2 = standard technique only (n = 28)
Intraoperative application of TachoSil® :
- reduced rate of postoperative lymphocysts after PL
- seems to provide a useful additional treatment option for reducing
drainage volume and preventing lymphocele development after PL

The Use of a Surgical Patch in the Prevention of Lymphoceles After
Extraperitoneal Pelvic Lymphadenectomy for Prostate Cancer: A
Randomized Prospective Pilot Study. Simonato A et al. (2009)
Femoralkanal (T1, 1x1cm) EIV, external iliac
vein
Fossa obturatoria (T2, 2.5x1cm) EIA, external iliac
artery
ON, obturator nerve.
* Clips & cautery
60 Patients with
prostatectomy
Standard
technique +
TachoSil® (n=30)
Standard
technique *
(n=30)

Simonato A et al. (2009)

TachoSil® reduced the risk of lymphocele
Significantly less lymphocysts
5 vs 19 (P=0.009)
Less symptomatic lymphocysts
2 vs 11 (P = 0.001)
Less surgery necessary
1 vs 4
Kontroll
TachoSil
3
0
3
0
5
1
9
2
11
Simonato A et al. (2009)

Laparoscopic transvesical repair of recurrent vesicovaginal
Fistula using with Fleece-bound sealing system
Erdogru T. et al. (2008)
• 37 year old woman with recurrent VVF
• 5 yr after initial operation
• TachoSil used as tissue barrier between Bladder and
Vagina

Summary:
Clinical benefits and possibilities with TachoSil®
 can be applied in areas of difficult accessibility.
Also suitable for MIS procedures
 can be applied in sensitive areas (e.g. close to nerves)
 can be used to cover large areas (overlapping patches)
 is highly flexible after sealing the wound and withstands extreme
stretching and compression  Haemostasis secured even under
demanding conditions
can be used immediately since no preparation is needed
By combining the adhesive properties of fibrin clotting with the mechanical
support of a collagen sponge, TachoSil® achieves
 haemostasis within 3-5 minutes

Thank you very much!

Mdm jeddah 1

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