| 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
|
|
|
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
|
|
|
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
|
|
|
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. |