| 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 |
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Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
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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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
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Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, New Delhi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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, |
|
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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. |
|
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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.
|
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| ExclusionCriteria |
|
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant Blinded |
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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 |
|
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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 |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) - for publication purpose
- By what mechanism will data be made available?
Response - Proposals should be directed to [roopam1699@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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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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