| CTRI Number |
CTRI/2024/10/075074 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing skin closure techniques in laparoscopic surgery |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL STUDY COMPARING THREE TYPES
OF SKIN CLOSURE TECHNIQUES IN LAPAROSCOPIC SURGERY. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puli Karthik Reddy |
| Designation |
Post Graduate Resident |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University), medical college, Pune, PIN:411043 |
| Address |
Department of General surgery, Bharati Vidyapeeth (Deemed to be University) medical college, Pune-Satara road, Pune.
Pune MAHARASHTRA 411043 India |
| Phone |
9535982005 |
| Fax |
|
| Email |
karthikpuli95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajeev Doshi |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University), medical college, Pune, PIN:411043 |
| Address |
Department of General surgery, Bharati Vidyapeeth (Deemed to be University) medical college, Pune-Satara road, Pune.
Pune MAHARASHTRA 411043 India |
| Phone |
9422005001 |
| Fax |
|
| Email |
Rajeevsdoshi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajeev Doshi |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University), medical college, Pune, PIN:411043 |
| Address |
Department of General surgery, Bharati Vidyapeeth (Deemed to be University) medical college, Pune-Satara road, Pune.
Pune MAHARASHTRA 411043 India |
| Phone |
9422005001 |
| Fax |
|
| Email |
Rajeevsdoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati hospital, pune-411043, INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Karthik Reddy |
| Address |
Department of General surgery, Bharati Vidyapeeth (Deemed to be University) medical college, Pune-Satara road,Pune-411043, INDIA |
| Type of Sponsor |
Other [Self] |
|
|
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 Karthik Reddy |
Bharati hospital |
Major operation theatre complex, 3rd floor, Bharati Vidyapeeth campus, Dhankawadi, Pune Pune MAHARASHTRA |
9535982005
karthikpuli95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHARATI VIDYAPEETH (DEEMED to be UNIVERSITY) MEDICAL COLLEGE, Pune-Satara road, Pune-411043, INSTITUTIONAL ETHICS COMMITTEE. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (4) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cyanoacrylate glue |
Type of skin closure method |
| Intervention |
Nylon suture material |
Type of skin closure method |
| Comparator Agent |
Skin stappler |
Type of skin closure method |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
75.00 Day(s) |
| Gender |
Both |
| Details |
Adult patients in the age group of 18 to 75 who are undergoing elective laparoscopic surgeries in whom umbilical port site is included and with no previous complications like infected cases or emergencies are included in this study. |
|
| ExclusionCriteria |
| Details |
1.Patients who are included previously, in whom the laparoscopic port site is extended during intra operative period ,due to any particular cause are excluded from this study.
2.Patients who come on emergency basis and patients with infected intra abdominal solid organs are excluded from this study.
3.Patients who lost to follow up and patients who are not willing to give consent are not included in this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To review the wound cosmetologically under HWES (Hollander wound evaluation score) in different skin closure techniques. |
Day0 Day3 Day 7 to 10 Day 21 to 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess complications of wound closure in different skin closure techiniques.
To evaluate inflammatory response of the wound pertaining to different
techniques under Southampton wound grading system.
To measure the post operative pain at the port sites in patients who underwent laparoscopic
procedures using VAS scoring system. |
Day0 Day3 Day 7 to 10 Day 21 to 30 |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/10/2024 |
| 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="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
|
The rationale for conducting a randomized controlled study comparing three types of skin closure techniques in laparoscopic surgery stems from the necessity to optimize postoperative outcomes and address patient concerns regarding recovery and cosmesis. Despite the advantages of laparoscopic methods, such as reduced pain and quicker recovery times, the issue of incisional hernias and unsatisfactory scar appearances remains a significant concern. These complications can lead to extended recovery periods, additional surgeries, and dissatisfaction with the cosmetic outcomes, all of which can affect the patient’s quality of life and increase healthcare costs. Current closure techniques include traditional suturing, the use of adhesives, and metal staples, each with its own set of advantages and potential drawbacks. For instance, sutures are versatile and widely used but can be time-consuming and may cause more noticeable scarring. Adhesives provide a quick and less invasive method that reduces scarring but might not offer the same level of strength and durability, particularly in high-tension areas. Staples are fast and consistent but can be painful upon removal and may lead to more prominent scars. This study aims to directly compare these three methods in a controlled setting to provide empirical data on their efficacy, focusing on specific outcomes such as healing time, incidence of herniation, pain levels, and cosmetic satisfaction. |