FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 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  
Status 
Not Applicable 
 
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.
 
Close