This document outlines a study protocol for evaluating a new minimally invasive laser surgery treatment for pilonidal sinus disease. The study aims to assess recurrence rates and healing times using laser surgery compared to other surgical techniques. It describes the candidate, guides, project summary, literature review, aims and objectives, materials and methods, and data collection forms for a prospective observational study comparing outcomes of patients undergoing laser surgery versus other treatments.

1. PROTOCOL FOR SUBMISSION OF THESIS FOR DEGREE IN DNB
IN GENERAL SURGERY
TITLE OF THESIS :-
NEW MINIMAL INVASIVE TREATMENT OF PILONIDAL SINUS
DISEASES BY LASER SURGERY : A PROSPECTIVE
OBSERVATIONAL STUDY
CANDIDATE NAME – DR. HIREN J. GONDALIYA
DNB Candidate , Department of General Surgery
Artemis Hospital ,Sector 51 , Gurugram,Haryana
NAME OF GUIDE: DR.PARITOSH S. GUPTA
MS,DNB(General Surgery),FMAS,MNAMS,FAIS,EPLM(IIM,C)
Head of department & Senior Consultant
Department of General ,MIS & Bariatric Surgery
Artemis Hospital ,Sector 51 , Gurugram,Haryana
NAME OF CO GUIDE: DR.ANSHUMAN KAUSHAL
MS,FNB(MAS),FACS,FCLIS(AIIMS),FMAS,FIAGES
Unit Head, Senior Consultant & Academic Coordinator
Department of General ,MIS & Bariatric Surgery

2. PROJECT SUMMARY
• A pilonidal sinus (PNS) is a small skin hole or tunnel. It may get filled with pus or
fluid, leading to the formation of a cyst or abscess. It appears in the cleft at the top
of the buttocks and causes severe pain. A pilonidal cyst usually contains dirt, hair,
and debris which oozes out pus and blood and emits a foul odour, if infected.
• Antibiotics are commonly used to treat this condition. However, the tunnel is quite
deep into the skin, so there is no permanent cure. The only permanent solution is
to surgically remove the sinus from the skin level deep into the tissue to the end of
the tunnel, where the tough hair that acts as the infection's seed is found.
• The best option to treat this condition is surgery. The doctor may suggest surgery
depending on the evaluation of your condition. Some of the surgeries are: laser
treatment, pilonidal cystectomy, and advanced flap surgery.
• Reasons to choose laser surgery for pilonidal sinus because of much less
recurrence, Less Pain, Less Cuts & Stitches Less Bleeding & Fast recovery ,Low
chance of infection
• This study aims to evaluate and compare the recurrance and healing time of
pilondal sinus after laser surgery vs other surgical technique

3. A limited number of SiLaT studies exist in the literature. Therefore, the aim of the current
study is to using such a minimally invasive technique in the management of SPND by
assessing the outcome and comparing it with other surgical technique

4. REVIEW IN LITERETURE
• Pilonidal sinus disease has led to heated debates since it was first described in the
medical literature. Although a consensus has been built on its etiology and
pathogenesis, the same course has not progressed for treatment modality. This review
is a short article about the process of pilonidal sinus disease from past to present.
Some important points were mentioned between the years 1833, which is accepted as
the milestone for the awareness of the disease, in which it was first reported until the
year of 1880, in which it was given its name. Although its name has been the same for
about two centuries, some other names such as “Jeep Disease” have also been used
depending on the population affected by the disease. At present, it is indisputable that
the disease is acquired. Large series were presented about the treatment in the last
two decades. Some surgical methods were even named after the ones who first
described them and they have many supporters. However, since the treatment
modalities have some advantages and disadvantages and they do not have marked
superiority over others, debates still continue. We hope that pilonidal sinus disease will
not lose its significance and be underrated in parallel with the developments in
technology and specialization in medicine.

5. • The beginning dates of many diseases as old as the history of humans is the date
that they were written for the first time. This date is 1833 for pilonidal sinus
disease. Herbert Mayo, British Physiologist, Anatomist and Surgeon (3rd April 1796-
28th June 1852), described it as a sinus containing hair follicles located in the
sacrococcygeal region in a woman, in 1833.
• Afterwards, an article named “Hair Extracted from an Ulcer” published by
Anderson in “Boston Medical Surgical Journal” in 1847 was found. He reported a
case of a 21-year-old male with a Scrophuloderma on his back, in his article written
as a letter to the editor. He reported that he drained the cavity after 3 wk and a
structure looking like a mesh made of multiple hairs of 2 inches long and after
complete drainage and cleaning of the hair in the cavity, the wound healed quickly.
Seven years later, in 1854 Warren reported 3 similar cases and this study is the first
case series known in the history of pilonidal sinus disease.
• The disease was given many names until 1880. Widely used ones are; sacral,
coccygeal or sacrococcygeal infundibulum, dermoid and dermoid fistula, congenital
dermal sinus and sacrococcygeal ectodermal sinus.
• Eventually, in 1880, Hodges named the disease with the statement of “I venture to
give the name of pilo-nidal (pilus, a hair, nidus, a nest) sinus to this rather singular
lesion.” He produced the word “pilonidal” by conjoining the word “pilus” which
means hair in Latin and “nidus” which means nest.

6. AIMS AND OBJECTIVES
AIMS:-
To assess the outcome in patients undergoing Laser repair of Pilonidal
sinus diseases
OBJECTIVE:-
Primary Objective:-
• Healing – assessed at end of 1 week, 2week , 4 week, 2 month duration .
• Recurrence – assessed at end of 3 months,6months,12 months
Secondary objective:-
• Post operative pain
• Infection
• Duration of hospital stay
• Return to work
• Wound dehiscence
• RESEARCH QUESTION
• evaluate and compare the effectivity , safety , feasibility of pilondal sinus surgery using
laser surgery with other surgical technique

7. MATERIAL AND METHODS
Study population :-
Patient in age range of 15 to 60 years in whom the diagnosis of pilonidal sinus
registerd with artemis health institute and scheduled for surgery with laser pilonidal
sinus repair
Study Design:
it is a prospective observational study in which patients with pilonidal sinus diseases
underwent Laser repair at Department of General ,MIS and Bariatric Surgery, Artemis
hospital ,gurugram .
Sample Size:
For the Prospective Observational Study, the sample size required can be calculated
according to the following formula
Where,
n = Total sample size
Z = SNV at α = 5% = 1.96 & α = 1% = 2.58
p = expected proportion in population based on previous/pilot studies
d = absolute error based on previous study or researcher corresponding to effect size

8. Calculation:
For the Prospective Observational Study, at 95 % confidence level with appropriate effect size
and the expected proportion in population is 87.5% and with 9% absolute error . Keeping
these values for the calculation of the sample size, our required sample size will be
• 53.64≈54
• Therefore, our required sample size for the study will be 60.
• Patient selection
inclusion criteria:
1.patient who have diagnosed a pilonidal sinus and willing for content for study
2.age 15 to 60 year ,both male and female gender
exlusion criteria :
1.patient unfit for surgery .
2.patient have other life theating condition
3.patient lost to follow up
4.concurant anorectal diseases
5.patient not want to willing for study
6.any pregnant female or suspected pregnancy at time of screening
7. Patients on cancer chemotherapeutic drugs, on immunosuppressant therapy.
8. uncooperative or mentally ill patients .

9. • Study duration :
january 2023 to december 2024
• STATISTICAL METHOD ANALYSIS:
• The data is collected & recorded in a tabular form. The continuous data will be
expressed as (Mean ± SD) and categorical data will be represented as absolute numbers
and percentages. The Kolmogorov-Smirnov tests will be performed to assess the
normality and the data will be analyzed with required statistical tests and descriptive
statistics. Parametric data are analyzed with student’s t-test/ independent t-test;
alternatively, the robust Non-Parametric data be analyzed using Wilcoxon Signed Rank
Test/ Mann-Whitney U test. The test criterion for statistical significance is being
considered by the researcher which is generally less than 0.05 (p<0.05).Nominal
Categorical data between the groups was compared using Chi-square test or Fisher’s
exact test as appropriate and use Pearson Correlation Coefficient for Normal data &
Spearman Correlation Coefficient for Non-Normal data to observe the extent of
relationship/correlation between the variables.
• All major data analysis packages as well as spreadsheets, such as Microsoft Excel and
SPSS are used as per requirement. For all statistical tests, the p-value is taken less than
0.05which indicates the valid evidence for statistical significance of the data.

10. • METHOD OF MEASUREMENT OF OUTCOME OF INTEREST:-
Variables data shall be recorded according to a pre-defined Proforma.
• DATA COLLECTION METHODS :-
Data collection forms shall be filled regarding the clinical data, investigations,
operative variables, outcome measures and during follow up and an electonic database
shall be maintained.
• DATA COLLECTION FORMS :-Attached in the Annexure.
• OPERATIVE TACHNIQUE
• All the surgical procedure were performed within the department of general surgery ,
artemis hospital ,gurugram
• Operative preparation :
• Informed consent for pilonidal sinus laser surgery was taken from patient. All patiebt
were kept nil per mouth at least 6 hour before surgery . Patient was asked to pass urine
just before going on to operation table.test dose of antibiotic given before incision.note
was made of laser surgery
• Laser pilonidal sinus repair procedure:
• Preoperative Preparation: Shaving the back;
• Intra-operatively, patients were put on the operating table

11. • Step 1
• Thorough evaluation of the lower back right from the Anal Verge to mid back
• Identify all the pits and associated abscess cavities. Missing one of the branches sinus tract
or abscess cavity is common cause of recurrence
• Step 2
• Crisscross incision is taken over the abscess cavity. Debride it well.
• Identify its connection with sinus
• Step 3
• Try to scoop the sinus tract as much as possible (Fig. 2).
• Use Radial Fibre to debride the sinus tract and abscess wall. Keep the setting at 10W with
1470nm diode laser. Deliver around 100 J of energy per centimeter, withdraw the fiber by
one centimeter and deliver another 100 J of energy per centimeter till the entire length is
debrided.
• Step 4
• Squeeze the fluid and muck out after laser debridement .Flush it with normal saline and
hydrogen peroxide.
• Step 5
• Make one crisscross incision at natal cleft for drainage through the pit. If the Pilonidal Sinus
is more than 4 cm long, make one additional crisscross incision in the centre of the sinus
tract to prevent collection in the recovery period.
• Step 6
Hemostasis achieved. Wound is keep open for drainage. Dressing done by betadine
solution and packing of sinus with betadine ointment and gauze piece apply over it .

12. ANNEXURES
• PROFORMA
• DEMOGRAPHICS :-
• Name: UHID :
• Age / Sex : Contact :
• Address : Occupation :
• Height : Weight : BMI:
• Date of Admission :
• Date of Surgery : Surgery :
• Date of Discharge : Hospital Stay :
• COMPLAINTS :-
• Pain : Duration :
• Swelling : Duration:
• Pus discharged: Duration:
• Constipation : Duration :
• Other complaints : Duration :
• History of any intervention :
• Co-morbidities :
• Other significant history