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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  
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 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  
Status 
Not Applicable 
 
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

 

 

 

 
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