| CTRI Number |
CTRI/2024/10/074680 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Psychosocial and sexual impacts of Genito-urinary and Rectovaginal fistula in women |
|
Scientific Title of Study
|
To study the psychosocial and sexual impact of Genito-urinary and Recto-vaginal Fistula in women in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashita Aggarwal |
| Designation |
Urogynae Fellow |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Obstetrics and gynaecology ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI New Delhi DELHI 110029 India |
| Phone |
9593253026 |
| Fax |
|
| Email |
ASHITA.AGG@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
RAJESH KUMARI |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI South DELHI 110029 India |
| Phone |
9911226176 |
| Fax |
|
| Email |
drrajeshkumari@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
ASHITA AGGARWAL |
| Designation |
UROGYNAE FELLOW |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI
DELHI 110029 India |
| Phone |
9593253026 |
| Fax |
|
| Email |
ASHITA.AGG@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| ROOM NO 728, 7TH FLOOR, DEPARTMENT OF OBS AND GYNAE, AIIMS, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Department of OBG, Ansari Nagar, New Delhi- 110029 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ashita Aggarwal |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
Department of OBG, AIIMS,New Delhi-110029 New Delhi DELHI |
9593253026
ASHITA.AGG@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, (2) ICD-10 Condition: N398||Other specified disorders of urinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Diagnosed case of Genito-Urinary Fistula/ Recto-vaginal fistula
2. Willing to participate in the study.
3. Willing to follow-up.
|
|
| ExclusionCriteria |
| Details |
1. Not willing to participate in the study.
2. Known case of malignancy.
3. Radiation fistula.
4. Patients with co-morbidities affecting Quality of life.
5. Colo-vaginal fistula
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Psychosocial health assessed by SF-36 questionnaire
2.Sexual health assessed by FSFI -6 questionnaire
|
10 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Operating time
2. Intra-operative complications
3. Total hospital stay.
4. Short-term and long-term complications |
10 YEARS |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
15/10/2024 |
| 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="1" Months="7" 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
|
It is a ambispective study to study the psychosocial and sexual impact of Genito-urinary and recto-vaginal fistula in women in India. Women with fistula experience constant leakage of urine and/or feces and it affects a woman’s physical, economic, psychological, sexual and social life. Quality of life of patients living with Genito-urinary fistula/ Rectovaginal fistula is deeply affected. Surgery is the mainstay of treatment. This study aims to assess the psycho-social and sexual impact of Genito-urinary and/or recto-vaginal fistulas in women. The primary objective of this study is to assess the impact on psychological health and social relationships and sexual health in women with Genito-Urinary fistula and recto-vaginal fistula. The secondary objective of this study is to assess physical health, to assess the risk factors associated with Genito-Urinary and recto-vaginal fistula, to assess intra-operative complications of various fistula surgeries and to assess short term and long-term complications of various fistula surgeries. METHODOLOGY-If you decide to participate in this study, and you had surgery for Genito-urinary fistula/ rectovaginal fistula at AIIMS, New Delhi, your surgical records will be retrieved and intraoperative and immediate post operative complications will be noted down from your case sheet. Your current symptoms pertaining to fistula or urinary/ bowel complaints, sexual dysfunction, chronic pain, discharge etc. will be asked in details and pelvic examination will be done .You will be asked to fill the SF-36 and FSFI questionnaire. If you have Genito-urinary/ rectovaginal fistula and are about to undergo some surgical procedure for correction of the same, your detailed history will be taken and pelvic examination will be done. SF-36 and FSFI questionnaire will be filled pre-operatively. During surgery, any intraoperative complications will be noted. Similarly, immediate postoperative complications will be noted. You will be asked to visit once at 6 weeks and then at 6 months. In both the visits, you’ll be asked for your complaints and symptoms and physical examination will be done. SF-36 and FSFI questionnaire will be filled at 6 weeks and 6 months. The primary outcomes are Psychosocial health assessed by SF-36 questionnaire and Sexual health assessed by FSFI -6 questionnaire. The secondary outcomes are Operating time, Intra-operative complications, Total hospital stay and Short-term and long-term complications |