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CTRI Number  CTRI/2025/08/093712 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To assess need of intraoperative urinary catheterization in women undergoing laparoscopic gynaecological surgeries. 
Scientific Title of Study   The feasibility of pre-surgery self-voiding without intraoperative urinary catheterization in laparoscopic procedures for benign adnexal pathologies: A Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rupambir Singh 
Designation  Junior Resident (Academic) 
Affiliation  AIIMS, New Delhi  
Address  95-1/2 Goutam Nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9682660413  
Fax    
Email  roopam1699@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anju Singh 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi  
Address  Room no 727, 7th floor, Mother and Child Block, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9958154179  
Fax    
Email  docanju.singh691@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anju Singh 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi  
Address  Room no 727, 7th floor, Mother and Child Block, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  09958154179  
Fax    
Email  docanju.singh691@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Research institution 
 
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 
Rupambir Singh  AIIMS, New Delhi  Room no 731, Gynae Office, 7th Floor, Mother and Child Block.
South
DELHI 
9682660413

roopam1699@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N97||Female infertility, (2) ICD-10 Condition: N832||Other and unspecified ovarian cysts, (3) ICD-10 Condition: N801||Endometriosis of ovary, (4) ICD-10 Condition: N971||Female infertility of tubal origin, (5) ICD-10 Condition: O001||Tubal pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Foleys Catheter  Urinary Catheterisation during the laparoscopic procedure shall be done in this group. 
Intervention  No use of Foleys catheter  Urinary Catheterisation in one group undergoing laparoscopic surgeries for benign adnexal pathologies and no catheterisation in the other group. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Scheduled for emergency or elective laparoscopic procedures for benign gynecological conditions (infertility, ectopic pregnancy, ovarian cystectomy, myomectomy, ectopic pregnancies)

ASA physical status I–II

Those willing to give informed written consent.
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the incidence of urinary tract symptoms and postoperative urinary tract infections (UTIs) in women with and without perioperative urinary catheterization.
2. To evaluate the incidence of microscopic hematuria in women with and without perioperative urinary catheterization.
 
1. Baseline (preoperatively)
2. Within 48 hours postoperatively
3. Within 7 days postoperatively. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the rate of postoperative urinary retention and need of urinary re-catheterisation in both groups.
2. To compare the length of hospital stay among two groups.
3. To compare the incidence of bladder injury among two groups.
 
1. Postoperatively upto 48 hours
2. From 48 hours to 7 days after surgery 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 3 
Date of First Enrollment (India)   15/09/2025 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response (Others) -  for publication purpose

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [roopam1699@gmail.com].

  6. For how long will this data be available start date provided 01-08-2027 and end date provided 01-08-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Urinary catheterization is commonly performed during benign laparoscopic gynaecological surgeries to prevent urinary retention and facilitate surgical access. However, routine catheter use may increase the risk of catheter-associated urinary tract infections (CAUTIs), delay mobilization, and reduce patient comfort—especially when the surgery is short and minimally invasive. Current evidence on the necessity of catheterization in such cases is limited and inconsistent. This study seeks to determine whether avoiding routine catheterization can reduce postoperative UTIs without increasing urinary retention, thereby supporting safer, more patient-centred perioperative care.

This study will be a prospective randomized controlled trial (RCT) conducted in the Department of Obstetrics and Gynaecology at AIIMS, New Delhi. The trial will be conducted over a period of 2 years, beginning from the date of ethical clearance. The study population will consist of women aged between 15- and 45-years undergoing emergency or elective laparoscopic gynaecologic surgeries for benign conditions, including ovarian cystectomy, laparoscopic myomectomy, diagnostic laparoscopy, and other non-hysterectomy procedures.

Group A shall consist of non-catheterised patients while Group B will include catheterised patients. The non-catheterization, self-voiding group (Group A) will not be catheterized unless intraoperative conditions necessitate it (e.g., prolonged surgery, bladder injury). While the catheterization group (Group A) will receive an indwelling Foley catheter immediately after induction of anaesthesia, which will be removed at the end of surgery or retained postoperatively as per the operating surgeon’s discretion. Allocation concealment will be ensured through unique identification numbers. Both the groups shall be required to void preoperatively. All surgeries will be performed by experienced gynaecologic laparoscopic surgeons under appropriate anaesthesia using standard laparoscopic techniques. Both groups will receive perioperative care as per institutional protocols. The type of surgery and the treatment received shall be unaffected by the allocation group in either case.

Data will be collected using a structured case record form designed for this study. Preoperative information including patient demographics, medical history, surgical indication, and baseline urine microscopy and culture will be recorded. Intraoperative variables such as type and duration of surgery and anesthesia, estimated blood loss, and need for intraoperative catheterization (if any) will also be documented. Postoperative assessments will include time to first spontaneous void, incidence of urinary retention (defined as inability to void within 6 hours post-surgery or post-void residual volume >150 mL measured by ultrasound), need for re-catheterization and the presence of any signs and symptoms of UTI. Postoperative urine samples will be collected for repeat urine microscopy and culture before discharge or within 7 days.



 
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