| CTRI Number |
CTRI/2023/11/059947 [Registered on: 17/11/2023] Trial Registered Prospectively |
| Last Modified On: |
13/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Other |
|
Public Title of Study
|
To Find out superiority of Vaginal or Laparoscopic closure of vault in Total Laparoscopic Hysterectomy |
|
Scientific Title of Study
|
Vaginal Versus Laparoscopic closure of vault in Total Laparoscopic Hysterectomy- A Prospective Observational study |
| 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 Chandana KR |
| Designation |
Postgraduate student |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
New PG hostel,Jawaharlal Nehru Medical College campus, Belagavi, Karnataka
Belgaum
KARNATAKA
5990010
India |
| Phone |
9916011626 |
| Fax |
|
| Email |
chkr9816@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M B BELLAD |
| Designation |
Professor |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Obstetrics and Gynecology
J N Medical College, Belagavi -10
Belgaum
KARNATAKA
5990010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Chandana KR |
| Designation |
Postgraduate student |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
New PG hostel,Jawaharlal Nehru Medical College campus, Belagavi, Karnataka
KARNATAKA
5990010
India |
| Phone |
9916011626 |
| Fax |
|
| Email |
chkr9816@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Jawaharlal Nehru Medical College, belagavi |
|
|
Primary Sponsor
|
| Name |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and gynecology, Jawaharlal Nehru medical college ,Nehru nagar, Belagavi -10 |
| Type of Sponsor |
Private medical college |
|
|
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 Chandana KR |
KLEs Dr Prabhakar Kore Hospital and Research centre |
Room No 10, Department of Obstetrics and gynecology .
KLEs Dr Prabhakar Kores Hospital and medical research centre , Belagavi, Karnataka
Belgaum
KARNATAKA |
9916011626
chkr9816@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Insitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing laparoscopic hysterectomy for benign conditions |
|
| ExclusionCriteria |
| Details |
1.Patients undergoing additional surgical procedures along with TLH in the same setting
2.Patients in whom Uterine or Cervical malignancies are diagnosed post operatively after undergoing TLH
3.Non consenting women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out superiority of Vaginal or Laparoscopic closure of vault in TLH |
To find out superiority of Vaginal or Laparoscopic closure of vault in TLH at immediate post op and at 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the post operative complications of TLH |
To find out the post operative complications of TLH upto 3 weeks post op |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/12/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Vaginal vault or cuff closure is a crucial and critical step of Total Laparoscopic Hysterectomy (TLH) and has been proposed to enhance post op outcome. There are two approaches to cuff closure in TLH i.e., Laparoscopic and vaginal.There is only limited data available in this area of the subject and hence there is a need for more studies to be done. The present study aims to assess and compare the two approaches with respect to the time consumption, and post opeartive complications.(Immediate and delayed (upto 3 weeks ) such as white discharge , bleeding PV ) |