| CTRI Number |
CTRI/2018/03/012363 [Registered on: 06/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of fistulectomy versus fistulotomy with marsupialization in patients of simple anal fistula. |
|
Scientific Title of Study
|
"A comparison in the management of Low Simple Anal Fistula using Fistulectomy and fistulotomy with marsupialization.
-A prospective, randomised, comparative study." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr shruti mujumdar |
| Designation |
General Surgery post graduate trainee |
| Affiliation |
Imambara District Hospital |
| Address |
superintendent office
Imambara district hospital
Akhan Bazar road
Chinsurah, Hooghly
West Bengal.
Hugli
WEST BENGAL
712101
India |
| Phone |
9008757565 |
| Fax |
|
| Email |
shrutimujumdar6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakas Chandra Samanta |
| Designation |
HOD and guide |
| Affiliation |
Imambara District Hospital |
| Address |
Dr Prakas Chandra Samanta
Department of General Surgery
care of superintendent office
Imambara district hospital
Akhan Bazar road
Chinsurah, Hooghly
West Bengal.
Hugli
WEST BENGAL
712101
India |
| Phone |
9433120271 |
| Fax |
|
| Email |
prakassamanta61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shruti mujumdar |
| Designation |
General Surgery post graduate trainee |
| Affiliation |
Imambara District Hospital |
| Address |
superintendent office
Imambara district hospital
Akhan Bazar road
Chinsurah, Hooghly
West Bengal.
WEST BENGAL
712101
India |
| Phone |
9008757565 |
| Fax |
|
| Email |
shrutimujumdar6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Imambara District Hospital-Hooghly |
|
|
Primary Sponsor
|
| Name |
Imambara District Hospital |
| Address |
Imambara District Hospital
Akhan Bazar road chinsurah
Hooghly 712101
West Bengal |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Prakas Chandra Samanta |
Head of the Department
Department of General Surgery
superintendent office
Imambara district hospital
Akhan bazar road
chinsurah
Hooghly-712101
West Bengal |
| Dr Ramanuj Mukherjee |
Associate Professor
Department of General Surgery
RGKar Medical college and Hospital
Kolkata
West Bengal-04 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shruti Mujumdar |
Imambara District Hospital |
Imambara District Hospital,
Akhan Bazar road
Chinsurah
Hooghly
West Bengal
Hugli
WEST BENGAL |
9008757565
shrutimujumdar6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,RGKar medical college and hospital, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
low simple anal fistula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fistulectomy |
fistulectomy involves the complete excision of the fistulous tract. |
| Intervention |
Fistulotomy with Marsupialization |
A fistulotomy is done which lays open the fistulous tract and the marsupialization of the fistulotomy wounds to approximate the wound edges. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Low trans-sphincteric -fistula tract involving less than the lower third of the anal sphincter.
2.A single internal and a single external opening.
3.Subcutaneous fistula.
4.The absence of a secondary tract.
5.Patients consenting for surgery
|
|
| ExclusionCriteria |
| Details |
1.Intersphinteric fistula.
2.All fistulae due to perineal injuries.
3.All congenital fistulae.
4.Patients with associated co-morbid conditions such as anal fissure, haemorrhoids, ulcerative colitis, crohns disease, intestinal tuberculosis, growth in anal canal etc.
5.Patients with a recurrent fistula.
6.Patients refusing to give consent for the surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome measure - wound healing time. |
for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome measures - post operative wound size, wound infection, post-operative pain, recurrence, anal incontinence and patient satisfaction. |
for 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2016 |
| Date of Study Completion (India) |
01/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Results:In our study we noted that the patients who underwent fistulotomy with marsupialization had faster wound healing time than the patients who underwent fistulectomy. These patients were also observed to have a shorter wound discharge time and smaller post operative wound size. Age, sex, BMI, operative time, post operative pain, wound infection, recurrence and patient satisfaction were statistically not significant. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction:Anal fistula are considered one of the commonest cause of persistant seropurulent discharge that irritates the neighbouring skin causing discomfort.Conventional surgical options for a simple anal fistula include a fistulotomy and a fistulectomy.A fistulectomy involves the complete excision of the fistulous tract. A fistulotomy lays open the fistulous tract where in small unepithelized wounds are left open which in turn hastens healing of the wound. Marsupialization of the fistulotomy wounds can reduce the healing time further.The objective of the study is to compare the post operative outcomes using fistulectomy versus fistulotomy with marsupialization in the treatment of low simple anal fistula. Methodology: This is a prospective, randomised and comparative study. It is conducted bsed on patients attending General surgery OPD in Imambara District Hospital,Hooghly from April 2016 to March 2017.This study compares the two surgical interventions, Fistulectomy versus Fistulotomy with marsupialization. The primary outcome of measure is the wound healing time and the secondary outcome of measures are the operative tie, post operative wound size, wound infection, post operative pain, recurrence, anal incontinence and patient satisfaction.The ethical clearence is obtained from IEC R.G.Kar Medical college and hospital, Kolkata.The written informed consent is obtained from all the participants prior to the study.The data is collected by using a structured study proforma and is entered into a microsoft excel spreadsheet and then statistically analyzed by SPSS version 24.0 and Graph Pad Prism version 5. Hypothesis: In patients with simple anal fistula, the post operative outcomes gained using fistulotomy with marsupialization are better than those gained by fistulectomy. |