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CTRI Number  CTRI/2025/08/092783 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To study the usefulness of Martius fat pad flap in the successful repair of conditions, fistula between vagina and anal canal and complete tear of the perineum 
Scientific Title of Study   Evaluation of the usefulness of Martius fat pad flap in rectovaginal fistula and complete perineal tear repair- A case control study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Richa Vatsa 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 702, Department of Obstetrics and Gynaecology, Mother and Child Block, AIIMS, New Delhi
Z-31, GF, Hauz Khas, New Delhi
South West
DELHI
110029
India 
Phone  9810248161  
Fax    
Email  dr.richavatsa@aiims.edu  
 
Details of Contact Person
Scientific Query
 
Name  Richa Vatsa 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 702, Department of Obstetrics and Gynaecology, Mother and Child Block, AIIMS, New Delhi
Z-31, GF, Hauz Khas, New Delhi
South West
DELHI
110029
India 
Phone  9810248161  
Fax    
Email  dr.richavatsa@aiims.edu  
 
Details of Contact Person
Public Query
 
Name  Richa Vatsa 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 702, Department of Obstetrics and Gynaecology, Mother and Child Block, AIIMS, New Delhi
Z-31, GF, Hauz Khas, New Delhi
South West
DELHI
110029
India 
Phone  9810248161  
Fax    
Email  dr.richavatsa@aiims.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Richa Vatsa 
Address  Room 702, Department of obstetrics and gynecology, 7th Floor, Mother child Block, AIIMS, New Delhi 110029 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Richa Vatsa  All India Institute of Medical Sciences  Room 702, Department of Obstetrics and Gynaecology, 7th Floor, Mother Child Block, AIIMS, Ansari Nagar, New Delhi
South
DELHI 
9810248161

dr.richavatsa@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  RVF or CPT repair with the use of Martius fat pad flap  CPT or RVF repair will be done using the standard technique.For Martius fat pad flap, it will take roughly 30 minutes extra. For Martius fat pad flap, the incision will be given over labia majora to remove fat pad graft with vascular attachment at lower end. The fat pad flap is carefully mobilized with dissection by cautery with preserved blood supply at lower end. A tunnel will be created under the vaginal tissue to pass the flap to the repair site. The flap is secured in place, over the repaired CPT/ RVF. This will be followed by muscle closure then vaginal mucosa closure. The incision on the labia will be closed. 
Comparator Agent  RVF or CPT repair without the use of Martius fat pad flap  CPT or RVF repair will be done using the standard technique. CPT or RVF repair will be done using the standard technique. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Cases
1. Patients with surgery for RVF or CPT repair with the use of MFPF

Control
1. Patients with RVF or CPT repair without the use of MFPF
 
 
ExclusionCriteria 
Details  Cases
1. RVF and CPT repair with colostomy
Controls
1. RVF and CPT repair with colostomy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients having complete symptomatic relief after surgery as calculated by Cleveland Clinic Incontinence scores  Percentage of patients having complete symptomatic relief after surgery as calculated by Cleveland Clinic Incontinence scores at Day 0, 1 month, 3 month and 6 month post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. Surgical site infection in the postoperative period
2. Wound breakdown in the postoperative period
3. Cause of RVF and CPT
4. Perineal disfigurement, as perceived by patient on VAS score of 10
5. Pain on Days 0, 3, 7,30 and 90 for prospective cases on VAS score of 10
6. Female sexual satisfaction index at 6 months
 
Surgical site infection till postoperative day 14
Perineal disfigurement, as perceived by patient on VAS score of 10
Pain on Days 0, 3, 7,30 and 90 for prospective cases on VAS score of 10
Female sexual satisfaction index at 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Both rectovaginal fistula (RVF) and complete perineal tear (RVF) results in abnormal communication between the vagina and rectum. Both these conditions lead to significant discomfort to patients and lead to impairment of quality of life. All these lead to significant psychological distress for patients. The success rate of RVF repair is 69%-80%, as reported in the literature. The failure of repair occurs due to compromised vascularity, infection, and repair under tension.  Martius fat pad flap (MFPF) uses vascularised fatty tissue from the labia to provide vascularity to the repaired tissue.  These flaps have been used for the repair of both VVF and RVFs. The success rate reported in the literature with these flaps is 65-100%.

Groups: Two groups will be there, depending on surgeon’s discretion of choice of surgery.

Cases: Patients who will undergo RVF or CPT repair with the use of MFPF

Control: Patients who will undergo RVF or CPT repair without the use of MFPF

Methodology:

The patients of RVF and CPT who who will undergo repair will be recruited. Details like age, demographic profile, cause of RVF/CPT, previous repair, surgical details, postoperative recovery, and any complication during surgery placement will be noted. Incontinence will be measured using Cleveland Clinic Incontinence scores pre- and post surgery. Then surgical details will include the type of surgery, duration of surgery and blood loss. The outcomes will be compared between two groups, one with MFPF and one without MFPF. The patients of the prospective part of the study will be called for regular follow-up for pain on Days 0, 3, 7,30 and 90 for prospective cases on a VAS score of 10. Further, sexually active patients will be asked to fill out a female sexual function index (FSFI) questionnaire pre- and at least 6 months post-surgery. 

 
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