| CTRI Number |
CTRI/2017/10/009976 [Registered on: 03/10/2017] Trial Registered Prospectively |
| Last Modified On: |
29/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two sutures in closure of vagina following small incision abdominal hysterectomy (laparoscopic) |
|
Scientific Title of Study
|
Comparison of unidirectional and bidirectional barbed suture in vaginal cuff closure during total laparoscopic hysterectomy- A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neethu S |
| Designation |
Junior Resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Dept of OBG, WCH Block, JIPMER, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9747014824 |
| Fax |
|
| Email |
neethu1091@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Murali |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Dept of OBG, WCH Block, JIPMER, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8940760837 |
| Fax |
|
| Email |
muralidraiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neethu S |
| Designation |
Junior Resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Dept of OBG, JIPMER, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9747014824 |
| Fax |
|
| Email |
neethu1091@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and research (JIPMER), WCH Block, D Nagar, Pondicherry-605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education And Research JIPMER |
| Address |
WCH Block, JIPMER, Dhanvantari Nagar, Pondicherry- 605006 |
| Type of Sponsor |
Government 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 Neethu S |
Jawarharlal Institue of Postgraduate Medical Education And Research (JIPMER) |
Dept of OBG, WCH Block, JIPMER, Dhanvantari Nagar , Pondicherry
Pondicherry
PONDICHERRY |
9747014824
neethu1091@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients who are scheduled to undergo TLH(total laparoscopic hysterectomy) for benign conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bidirectional barbed suture |
Duration of vaginal cuff closure in total laparoscopic hysterectomy using bidirectional barbed suture |
| Comparator Agent |
Unidirectional barbed suture |
Duration of vaginal cuff closure in total laparoscopic hysterectomy using unidirectional barbed suture |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Patients who are scheduled to undergo total laparoscopic hysterectomy for benign conditions |
|
| ExclusionCriteria |
| Details |
Uterus >20 Weeks
Acute PID |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare vault closure time during total laparoscopic hysterectomy (TLH) using unidirectional barbed suture with bidirectional barbed suture |
Duration in minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative vaginal bleeding, infection and cuff dehiscence between the unidirectional and bidirectional barbed suture in total laparoscopic hysterectomy |
2 and 4 weeks after the procedure |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2017 |
| Date of Study Completion (India) |
16/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Total laparoscopic hysterectomy (TLH) is a well established alternative to transabdominal hysterectomy for treatment of benign uterine disease with special advantage of less pain, shorter hospitalisation, earlier return to normal activities and better cosmetic outcome. In TLH when vaginal vault is closed laparoscopically intra corporeal knot tying is done which requires experience. With development in technology , several solutions have been proposed to reduce stress on surgeons. One of these is Barb technology, which has microscopic etching which allows self anchoring without the need of knots
In this study the time taken for closure of vaginal cuff in TLH using unidirectional and bidirectional barbed suture will be compared. Hypothesis: Unidirectional barbed suture have to be locked by a loop at one end , this step is not needed for bidirectional barbed suture. Hence time taken for bidirectional barbed suture closure of vaginal cuff may be shorter |