| CTRI Number |
CTRI/2024/05/066985 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, 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
|
COMPARISION OF POLYGALACTIN 910 WITH BARBED SUTURES FOR VAGINAL CUFF CLOSURE IN TOTAL LAPROSCOPIC HYSTERECTOMY |
| 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 PREETHI MASKI |
| Designation |
Junior Resident |
| Affiliation |
Adichunchanagiri Institute Of Medical Sciences, B.G. Nagara |
| Address |
Department Of Obstetrics and Gynecology, Adichunchanagiri Institute Of Medical Sciences,
B.G. Nagara
Mandya
KARNATAKA
571448
India |
| Phone |
8971879158 |
| Fax |
|
| Email |
preetumaski9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MAHENDRA G |
| Designation |
Professor |
| Affiliation |
Adichunchanagiri Institute Of Medical Sciences, B.G. Nagara |
| Address |
Department Of Obstetrics and Gynecology, Adichunchanagiri Institute Of Medical Sciences,
B.G. Nagara
Mandya
KARNATAKA
571448
India |
| Phone |
9964026610 |
| Fax |
|
| Email |
drmuba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PREETHI MASKI |
| Designation |
Junior Resident |
| Affiliation |
Adichunchanagiri Institute Of Medical Sciences, B.G. Nagara |
| Address |
Department Of Obstetrics and Gynecology, Adichunchanagiri Institute Of Medical Sciences,
B.G. Nagara
Mandya
KARNATAKA
571448
India |
| Phone |
8971879158 |
| Fax |
|
| Email |
preetumaski9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adichunchanagiri Institute of Medical Sciences,
B.G. Nagara 571448 |
|
|
Primary Sponsor
|
| Name |
Adichunchanagiri Institute Of Medical Sciences |
| Address |
Adichunchanagiri Institute Of Medical Sciences,
B.G. Nagara 571448 |
| 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 Preethi Maski |
Adichunchanagiri Institute Of Medical Sciences |
Department Of Obstetrics and Gynecology Adichunchanagiri Institute Of Medical Sciences,
B.G. Nagara 571448
Mandya
KARNATAKA |
8971879158
preetumaski9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Adichunchanagiri Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z907||Acquired absence of genital organ(s), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Polyglactin 910 suture |
Duration in minutes for vaginal cuff closure in total laparoscopic hysterectomy using Polyglactin 910 suture |
| Intervention |
Unidirectional Barbed suture with end stopper |
Duration in minutes for vaginal cuff closure in total laparoscopic hysterectomy using Unidirectional Barbed suture with end stopper |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients undergoing total laparoscopic hysterectomy
2. Abnormal uterine bleeding
3. Chronic PID
4. Age more than 30 years
5. Those who have given informed consent
|
|
| ExclusionCriteria |
| Details |
1. Age less than 30 years
2. Those undergoing total abdominal hysterectomy
3. Those undergoing vaginal hysterectomy
4. Patients with malignancy
5. Patients with coagulation disorder
6. Patients who require prolapse repair |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare vault closure time during total laparoscopic hysterectomy using unidirectional barbed suture with polyglactin 910 suture |
Baseline Day of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate total operative time from first incision till closure |
Day of surgery |
| To evaluate post operative pain using 10 point Visual Analog Scale score |
Day of surgery post-surgery day 2 day of discharge post surgery day 7 post surgery day 21 |
| To evaluate intraoperative handling property of both the suture using Product Usage Assessment Scale |
Day of surgery |
| To assess the length of hospital stay |
Day of surgery till day of discharge |
| To assess vaginal cuff related complications |
Day of surgery post-surgery day 2 day of discharge post surgery day 7 post surgery day 21 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/05/2024 |
| 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 one of the very commonly performed gynecological procedures. In the recent times a shift is seen in preference of laparoscopic hysterectomies over laparotomy. Laparoscopy has several important advantages over laparotomy, which include less pain, reduced recovery time, shorter hospital stay, and avoidance of a large operative scar[1]. Laparoscopic hysterectomy has been reported to have higher rates of vaginal complications including vaginal cuff dehiscence compared to open surgery. Laparoscopic colpotomies using electrosurgical devices likely cause more tissue necrosis and devascularization owing to higher vaginal complications. Laparoscopic hysterectomy is also associated technical difficulty and long learning curve, that might add to the complications rate. Laparoscopic suturing of the vaginal cuff and knotting is the most challenging step in total laparoscopic hysterectomy (TLH) and requires surgical skill. In TLH, the vaginal cuff can be sutured laparoscopically (either intracorporeal or extracorporeal) and vaginally[2]. Endoscopic suturing with knotting increases the time of surgery considerably[3]. The barbed suture is a relatively newer suture material. It is being used for closure in laparoscopic surgeries. The haemostatic properties and ease of use has made barbed sutures (Trubarb) a preferred mode of closure. Currently polyglactin 910 (Trusynth) is widely used for closure of vaginal cuff, by continuous interlocking suturing and knotting for the closure of vaginal cuff in total laparoscopic hysterectomies. |