| CTRI Number |
CTRI/2024/05/067938 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To See Vault Dehiscence and other complications Of Vault Closure By Vaginal Route
Compared To Vault Closure Done Laparoscopically Through Abdomen During The Last Step Of Total Laparoscopic Hysterectomy In Perimenopausal Women From Rural India |
|
Scientific Title of Study
|
Comparison Of Outcomes Of Vaginal Cuff
Closure Versus Laparoscopic Cuff Closure In
Total Laparoscopic Hysterectomy In
Perimenopausal Women |
| 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. Dhruva Halani |
| Designation |
Senior Resident |
| Affiliation |
DMIHER (Datta Meghe Instiute of Higher Education and Research) |
| Address |
Department Of OBGY, Ground Floor Block B, AVBRH Hospital, Datta Meghe Instiute of Higher Education and Research, Sawangi, Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7567022833 |
| Fax |
|
| Email |
dhruva.halani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manjusha Agrawal |
| Designation |
Proffessor |
| Affiliation |
DMIHER (Datta Meghe Instiute of Higher Education and Research) |
| Address |
Department Of OBGY, Ground Floor Block B, AVBRH Hospital, Datta Meghe Instiute of Higher Education and Research, Sawangi, Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9518592696 |
| Fax |
|
| Email |
badnemanju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Dhruva Halani |
| Designation |
Senior Resident |
| Affiliation |
DMIHER (Datta Meghe Instiute of Higher Education and Research) |
| Address |
Department Of OBGY, Ground Floor Block B, AVBRH Hospital, Datta Meghe Instiute of Higher Education and Research, Sawangi, Wardha, Maharashtra, India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7567022833 |
| Fax |
|
| Email |
dhruva.halani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research House, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India. 442001 |
|
|
Primary Sponsor
|
| Name |
Dr Dhruva Halani |
| Address |
Deptartment Of Obstetrics and Gynaecology, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha |
| 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 DHRUVA HALANI |
Datta Meghe Instiute of Higher Education and Research |
Department Of OBGY, Ground Floor Block B, AVBRH Hospital, Datta Meghe Instiute of Higher Education and Research, sawangi, wardha, maharashtra, india
Wardha
MAHARASHTRA |
7567022833
dhruva.halani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dattta Meghe Institute Of Higher Education And Research Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N958||Other specified menopausal and perimenopausal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Suturing of the vault with vicryl 2347 suture |
suturing of the vault after total laparoscopic hysterectomy will be done by laparoscopic route (endosuturing) (10-20 minutes) |
| Intervention |
Suturing of the vault with vicryl 2347 suture |
suturing of the vault after total laparoscopic hysterectomy will be done by vaginal route (5-10 minutes) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient having benign indication for TLH (benign indications like fibroid,
adenomyosis, AUB)
2. Perimenopausal age group (40-55 years) |
|
| ExclusionCriteria |
| Details |
1. Gynaecological malignancies
2. Unfit for TLH |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vault dehiscence, hamatoma, cuff related complications |
baseline, After 1 and 2 months of followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of suturing of cuff, surgeon difficulty |
baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
Modification(s)
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="0"
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
|
Hysterectomy is the most common surgical intervention on the female genital tract following cesarean delivery. Suturing the vaginal cuff is the last stage of TLH. A variety of procedures are available, depending on the surgeon preference. It is possible to execute interrupted or continuous suturing, transvaginal cuff closure, and laparoscopic suturing. Due to the complexity of laparoscopic suturing procedures, the closure of the vaginal cuff is the most challenging aspect. Significant drawbacks like cuff dehiscence, intestinal injury, vault bleeding, cuff infection etc. of the procedure include the need for sophisticated surgical skills, a lengthy learning curve, and a time-consuming procedure.
In a total of 16 patients undergoing TLH at OBGY department of AVBRH, they will be simply randomized in a 1:1 ratio to have either laparoscopic or transvaginal closure of the vaginal cuff, and patients will be kept in the dark about the manner of closure. Post op cuff-related complications will be followed up after 1 and 2 month postoperative period like partial cuff disruption, dehiscence, granulation, cuff infection and yellowish vaginal discharge and will be analyzed.
The present study is also of value for providing new insight in the possible risk factors for vaginal dehiscence and vaginal cuff complications, because etiological studies and theories have not yet been supported by substantial evidence. There is an ongoing need to study the superiority of one vaginal vault suturing technique over another as the available data is limited. |