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CTRI Number  CTRI/2025/05/087674 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 24/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between post operative complications in vault closure by two different routes i.e endoscopic and transvaginal route after Total Laparoscopic Hysterectomy  
Scientific Title of Study   Post Operative Morbidity in Laparoscopic Vs Transvaginal cuff closure after Total Laparoscopic Hysterectomy - A Double blind Randomised controlled trial 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Bindia Goyal  
Designation  Junior resident  
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES , BATHINDA 
Address  Department of Obstetrics and Gynaecology , AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  6284116158  
Fax    
Email  bindiagoyal0115@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lajya Devi Goyal 
Designation  Professor and Head of Department of Obstetrics and Gynaecology  
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES , BATHINDA  
Address  Department of Obstetrics and Gynaecology , AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9417658846  
Fax    
Email  lajja.goyal@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lajya Devi Goyal 
Designation  Professor and Head of Department of Obstetrics and Gynaecology 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES , BATHINDA  
Address  Department of Obstetrics and Gynaecology , AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9417658846  
Fax    
Email  lajja.goyal@rediffmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences , Bathinda Pin code- 151001 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bathinda  
Address  All India Institute of Medical Sciences , Bathinda Mandi Dabawali Road , Bathinda Pin code - 151001 
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 Bindia Goyal   All India Institute of Medical Sciences , Bathinda   Department of Obstetrics and Gynaecology,
Bathinda
PUNJAB 
6284116158

bindiagoyal0115@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arm 1 - Laparoscopic Cuff Closure  Patients In Arm 1 Will Be Called In Post Operative Period To See Post Operative Morbidity After Laparoscopic Cuff Closure .Post operative complications like vaginal cuff dehiscence , infections etc will be seen . 
Intervention  Arm 2 - Transvaginal Cuff Closure  Patients Will Be Called In Post Operative Period After Transvaginal Cuff Closure To See Post Operative Morbidity . Post operative complications like vaginal cuff dehiscence , infections etc will be seen 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  41.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  All women scheduled for elective TLH age more than 40yrs and who underwent completion of entire procedure by laparoscopic approach up to colpotomy and Benign condition as indication to hysterectomy  
 
ExclusionCriteria 
Details  Patient undergoing hysterectomy for any malignant condition
Previous radiation therapy
Known allergy to suture material used in the study
Non-consenting women
Patients dropped out from the follow up were excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To Compare the Incidence of Vaginal Vault Dehiscence Between Laparoscopic and
Transvaginal Cuff Closure.  
To Compare the Incidence of Vaginal Vault Dehiscence Between Laparoscopic and Transvaginal Cuff Closure. The patients will be asked to follow‑up after 1 week, one month, and thereafter three months, if no other indication for frequent visits 
 
Secondary Outcome  
Outcome  TimePoints 
To compare other post operative complications and hospital stay   Detection of vaginal complications will be conducted through:

An objective assessment during the follow-up appointment
Information from hospital admissions, emergency department visits, or physician
evaluations within the 3-month follow-up period, gathered during recent medical
history assessment.  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   05/06/2025 
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="1"
Months="6"
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  
After a detailed history and physical examination of a female more than 40 years and considering inclusion and exclusion criteria, patients will be recruited for the study. A participant information sheet will be given to the patients and after a verbal explanation about the study, written informed consent in patient’s vernacular language will be taken. A case record form will be used for collecting the data. The demographic history of patient will be noted. Menstrual history, contraceptive history, obstetric history, personal and family history will be asked. A detailed examination of the patient will be done which will include general physical examination, respiratory, cardiovascular, abdominal examination and pelvic examination which will include per speculum, per vaginum examination, if required. All routine investigations like complete blood count (CBC), Random blood sugar (RBS), urine routine and microscopy (URINE R/M), serum electrolytes (SE), liver function test (LFT), blood group (ABORH), prothrombin tine/international normalized ratio (PT/INR), viral markers, and ultrasonography if required will be done. 11 Randomisation will be done by using computer generated random number tables. It will be a double blind randomized controlled trial . In this patient undergoing TLH and observer who will observe patient on follow up will be blind , hence double blind randomized controlled trial . All eligible participants who will give consent for the study will be randomly allocated to group A undergoing Laparoscopic cuff closure) or group B (undergoing Transvaginal cuff closure). Preoperative patient preparation, surgical methods, and postoperative patient care will be comparable. Their descriptive medical records and thorough patient details in their personal files will be maintained. At the time of discharge, the patients will be advised to avoid coitus for 2 weeks and heavy weight lift for 6 weeks. The patients will be asked to follow‑up after 1 week, one month, and thereafter three months, if no other indication for frequent visits. The 3 month follow-up period has been chosen because it has shown that almost all vaginal cuff dehiscences after TLH occur within 2 months after surgery. Assessment of vaginal cuff complications will be done either subjectively or objectively. This complications include vaginal cuff dehiscence , post operative vaginal bleeding , vaginal cuff hematoma and post operative infections .
Detection of vaginal complications will be conducted through: 
• An objective assessment during the follow-up appointment
• Information from hospital admissions, emergency department visits, or physician evaluations within the 3-month follow-up period, gathered during recent medical history assessment.
 
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