FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069655 [Registered on: 28/06/2024] Trial Registered Prospectively
Last Modified On: 27/06/2024
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   A study comparing two different types of suturing materials used in laparoscopic gynaecological surgeries. 
Scientific Title of Study   Efficacy of Barbed versus Polyglactin 910 for Vault closure in Total Laparoscopic Hysterectomy in a Tertiary care center in South India - A Randomized 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 Balaji Shri Vishnu V 
Designation  DNB Resident 
Affiliation  Southern Railway Headquarters Hospital, Chennai 
Address  Room No RH 11/201 Labour room 1st Floor Department of Obstetrics and Gynaecology Southern Railway Headquarters Hospital Constable Road Ayanavaram
Room No 221 Gynaec OPD 1st Floor Department of Obstetrics and Gynaecology Southern Railway Headquarters New Hospital Complex Constable Road Ayanavaram
Chennai
TAMIL NADU
600023
India 
Phone  9442719924  
Fax    
Email  balajishrivishnu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K S Raja Rajeswari  
Designation  Additional Chief Health Director 
Affiliation  Southern Railway Headquarters Hospital, Chennai 
Address  Room No RH 11/201 Labour Room 1st Floor Department of Obstetrics and Gynaecology Southern Railway Headquarters Hospital Constable Road Ayanavaram

Chennai
TAMIL NADU
600023
India 
Phone  9840808586  
Fax    
Email  drrajarajeswari7@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Balaji Shri Vishnu V 
Designation  DNB Resident 
Affiliation  Southern Railway Headquarters Hospital, Chennai 
Address  Room No RH 11/201 Labour Room 1st Floor Department of Obstetrics and Gynaecology Southern Railway Headquarters Hospital Constable Road Ayanavaram

Chennai
TAMIL NADU
600023
India 
Phone  9442719924  
Fax    
Email  balajishrivishnu@gmail.com  
 
Source of Monetary or Material Support  
Southern Railway Headquarters Hospital Constable Road Ayanavaram Chennai 600023 
 
Primary Sponsor  
Name  Southern Railway Headquarters Hospital 
Address  Southern Railway Headquarters Hospital Constable Road Ayanavaram Chennai 600023 
Type of Sponsor  Other [Central Government Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Balaji Shri Vishnu V  Southern Railway Headquarters Hospital  Room No RH 11/201 Labour Room 1st Floor Department of Obstetrics and Gynaecology Southern Railway Headquarters Hospital Constable Road Ayanavaram Chennai 600023
Chennai
TAMIL NADU 
9442719924

balajishrivishnu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Southern Railway Headquarters Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Barbed suture  Spiral poly-dioxanone knotless tissue control device, unidirectional with end loop Frequency - used once during vault closure in Total laparoscopic hysterectomy Duration - Not applicable (One time use) 
Intervention  Polyglactin 910  Polyglactin 910 i.e. Vicryl is a synthetic absorbable, coated, braided, multifilament suture material made of 90% glycolide and 10% l-lactide Frequency - used once during vault closure in Total laparoscopic hysterectomy Duration - Not applicable (One time use) 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  All women undergoing total laparoscopic hysterectomy for benign gynaecological conditions, who are willing for the study. 
 
ExclusionCriteria 
Details  1. Women with gynaecological malignancies
2. Immunocompromised patients
3. Morbidly obese patients
4. Unfit for surgery due to general condition
5. Participants not consenting for study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time taken for closure of vault intracorporealy between barbed and polyglactin 910 in total laparoscopic hysterectomy  Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of Post Operative complications between Barbed suture & Polyglactin 910 like
1 surgical site infection (vault)
2 dyspareunia
3 vault dehiscence 
4 weeks 
Surgical difficulty in vault closure between Barbed & Polyglactin 910 assessed using Visual Analogue Scale (VAS)  Baseline 
Post operative pain between Barbed & Polyglactin 910 assessed using Visual Analogue Scale (VAS)  24 hours & Day 3 
Cost difference between Barbed & Polyglactin 910  Baseline 
 
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)   08/07/2024 
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="2"
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   Hysterectomy is the surgical removal of uterus done for benign and malignant gynaecological conditions. Hysterectomy is performed by various approaches viz. Abdominal hysterectomy (AH), Vaginal hysterectomy (VH), Laparoscopic assisted Vaginal hysterectomy (LAVH), Laparoscopic hysterectomy (LH(a)), Total Laparoscopic hysterectomy (TLH), Robotic assisted hysterectomy (RH) and Single-port Laparoscopic hysterectomy (SP-LH) & Mini-Laparoscopic hysterectomy (mini-LH). 

Total Laparoscopic Hysterectomy is the procedure where the entire operation is performed laparoscopically including suturing of the vaginal vault and there is no vaginal component except for the removal of the uterus. It requires higher degree of laparoscopic surgical skill. A new challenge in minimally invasive laparoscopic surgeries is the ability to quickly and properly tie the surgical knots. In TLH, the vaginal cuff closure is the technically difficult part and improper closure can lead to vault dehiscence. Minimally invasive procedures seem to increase the risk of vaginal cuff dehiscence (VCD). Vaginal vault closure in laparoscopic hysterectomy is performed by various techniques and using various suture materials viz. vault closure vaginally or intracorporeally, using barbed or vicryl sutures, unidirectional or bidirectional barbed sutures, suturing with interrupted / running / figure of 8 sutures. 

Barbed suture is a new class of suture introduced to aid surgeons during laparoscopic suturing, with the aim to reduce operative time, blood loss, and vaginal dehiscence. Barbed sutures are different from the conventional sutures as barbed sutures do not require a knot placement and the barbs present in the suture material act as self-retaining points at regular intervals along the suture that makes the technique knotless and distributes the tension equally in the tissue. The surgical knot reduces the tensile strength of the suture by thinning and stretching the suture. This intrinsic disadvantage of any suture is avoided by barbed sutures. These sutures also reduce the operating time by eliminating the need for placement of knots which is the technically challenging task in intracorporal suturing of laparoscopic surgeries.  

This study compares Polyglactin 910 and Barbed suture used for vault closure intracorporeally in Total Laparoscopic Hysterectomy. The former need knotting and the latter does not need knotting, thus the latter helps in saving time and brings about surgical ease while operating especially for a beginner in laparoscopic surgeries. But we need evidence to establish that one suture is superior over the other including the overall outcome like the incidence of postoperative complications, postoperative pain, quality of life, cost of material, time saved, surgical ease, etc. In India, only less number of studies are available comparing these to sutures for vault closure. This study uses a reliable methodology - Randomized Controlled Trial and the conclusion of the trial will add evidence to the existing literature and useful for surgical practice in future.
 
Close