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CTRI Number  CTRI/2024/10/075064 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 30/04/2025
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   COMPARISON BETWEEN SINGLE PORT LAPAROSCOPIC VERSUS CONVENTIONAL THREE PORT APPENDICECTOMY  
Scientific Title of Study   A STUDY ON SINGLE PORT LAPAROSCOPIC VERSUS CONVENTIONAL THREE PORT APPENDICECTOMY 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. Manisha Rathod 
Designation  second year surgery Resident Doctor  
Affiliation  Government Medical College Bhavnagar 
Address  Room No.802 PG 3 ,Sir T hospital and government medical college ,Bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9624058794  
Fax    
Email  manisharathod607@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSamir M shah  
Designation  Head and professor of general surgery  
Affiliation  Sir T hospital Bhavnagar  
Address  General surgery department Sir T hospital Bhavnagar 364001

Bhavnagar
GUJARAT
364001
India 
Phone  9427215253  
Fax  0278-2422011  
Email  shah.samir1570@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrSamir M shah  
Designation  Head and professor of general surgery  
Affiliation  Sir T hospital Bhavnagar  
Address  General surgery department Sir T hospital Bhavnagar 364001

Bhavnagar
GUJARAT
364001
India 
Phone  9427215253  
Fax  0278-2422011  
Email  shah.samir1570@gmail.com  
 
Source of Monetary or Material Support  
Sir T hospital and government medical college Bhavnagar,gujrat, india 364001  
 
Primary Sponsor  
Name  SIR T HOSPITAL BHAVNAGAR 
Address  Sir T hospital bhavnagar and government medical college Bhavnagar , gujrat, india 364001 
Type of Sponsor  Government medical college 
 
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 MANISHA RATHOD  SIR T HOSPITAL BHAVNAGAR  Surgical IPD ,department of general surgery,SIR T HOSPITAL BHAVNAGAR And medical college bhavnagar, 364001
Bhavnagar
GUJARAT 		 9624058794

manisharathod607@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K37||Unspecified appendicitis, (2) ICD-10 Condition: K36||Other appendicitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  laparoscopic appendicectomy  we are comparing single port versus three port laparosocpic appendicectomy. 
Intervention  LAPROSCOPY APPENDICECTOMY  We are doing laparoscopic appendicectomy using single port and three port  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients diagnosed with acute,subacute or chronic appendicitis.

 
 
ExclusionCriteria 
Details  1.Patients with a history of previous abdominal surgery that could affect the surgical approach for appendectomy.

2.Patients with a known or suspected bleeding disorder.

3.Patients who are pregnant.

4.Patients with known cardiovascular, respiratory, or renal co-morbidities that could affect the surgical outcomes or increase the risk of postoperative complications

5.Patients with an ASA score of IV or V.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the patient satisfaction, post operative pain, hospital stay, duration of surgery of these two surgical approaches in order to provide evidence-based guidance to healthcare professionals regarding the optimal approach for appendectomy
 		 one year
 
 
Secondary Outcome  
Outcome  TimePoints 
to determine the most effective approach for patients undergoing appendectomy
provide critical information on potential complication
improve patient safety and surgical outcome
guide decision making for healthcare providers
 		 one year 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   N/A 
Date of First Enrollment (India)   20/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
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  
•Appendectomy is a commonly performed surgical procedure for the treatment of acute appendicitis.
•While the traditional three-port laparoscopic approach is the standard technique, the single-port laparoscopic approach has emerged as an alternative with potential benefits such as reduced postoperative pain, and faster recovery.
•This study aims to compare the clinical outcomes, safety, feasibility, patient satisfaction, return to normal work and effectiveness of single port laparoscopic versus conventional three port appendectomy, and provide evidence-based recommendations for the optimal surgical approach for appendectomy.
 
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