| 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
|
|
|
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
|
|
|
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. |