| 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
|
|
|
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
|
|
|
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. |