| CTRI Number |
CTRI/2024/10/075568 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| 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 clinical trial to compare operative time and postoperative recovery and complications in two different methods of appendicular stump closure,hem-o-lok® clips and endo loops in laparoscopic appendectomy done in appendicitis patients. |
|
Scientific Title of Study
|
Comparative Effectiveness and safety of Hem-o-Lok® clips versus Endo loops for Appendicular stump closure in Laparoscopic Appendectomy: A randomized controlled trial in a Tertiary Care Center in Eastern Uttar Pradesh. |
| 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 Darshan Jalwal |
| Designation |
Junior resident ,Department of general surgery |
| Affiliation |
All India Institute of Medical Sciences,Gorakhpur |
| Address |
Department of general surgery,All India Institute of Medical Sciences,Gorakhpur,India,273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8619105186 |
| Fax |
|
| Email |
Jalwaldarshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukul Singh |
| Designation |
Associate professor ,Department of general surgery |
| Affiliation |
All India Institute of Medical Sciences,Gorakhpur |
| Address |
Department of general surgery,All India Institute of Medical Sciences,Gorakhpur,India,273008.
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9997343119 |
| Fax |
|
| Email |
SINGHMUKUL3911@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukul Singh |
| Designation |
Associate professor ,Department of general surgery |
| Affiliation |
All India Institute of Medical Sciences,Gorakhpur |
| Address |
Department of general surgery,All India Institute of Medical Sciences,Gorakhpur,India,273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9997343119 |
| Fax |
|
| Email |
SINGHMUKUL3911@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Gorakhpur,India,273008 |
|
|
Primary Sponsor
|
| Name |
Dr Darshan Jalwal |
| Address |
Department of general surgery,All India Institute of Medical Sciences,Gorakhpur,India,273008 |
| 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 Darshan Jalwal |
All India Institute of Medical Sciences,Gorakhpur |
Department of general surgery,All India Institute of Medical Sciences,Gorakhpur,India,273008
Gorakhpur
UTTAR PRADESH |
8619105186
Jalwaldarshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee ,All India Institute of Medical Sciences,Gorakhpur,India ,273008 |
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 |
Endo Loops |
In this group we will be using endo loops for appendicular stump closure in laparoscopic appendectomy and will document the intraoperative time required and postoperative complications . |
| Intervention |
Hem-o-Lok® Clips |
In this group we will be using Hem-o-Lok® clips for appendicular stump closure in laparoscopic appendectomy and will document the intraoperative time required and postoperative complications . |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.acute appendicitiS
2.chronic appendicitis
|
|
| ExclusionCriteria |
| Details |
1.perforated appendicitis
2.necrotizing appendicitis
3.pregnant females
4.laparoscopic converted to open appendectomy
5.concomitant another procedure
6.patient not willing to be part of study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The time required to close the appendicular stump and investigate the differences in post-operative complications, including surgical site infections and stump leaks, as well as the length of hospital stay and recovery times between the two closure techniques. |
Operative time and postoperative day 40. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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) |
Open to Recruitment |
|
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
|
During laparoscopic appendectomy, the appendiceal stump can be ligated and resected using various methods such as an endoloop, endostapler, or polymeric clip. While an endoloop may pose some challenges in handling, a polymeric clip offers the advantage of easy application. The safety of polymeric clips in this procedure is well-established,with several studies noting shorter surgical times compared to endoloops. Recent guidelines also endorse the use of polymeric clips due to their cost effectiveness and efficiency. Furthermore, study showed fewer overall complications than using endoloops . However, there is a lack of sufficient evidence based data on this topic. This study aims to compare the effectiveness and safety of the widely available polymer locking ligation system that is Hem o Lok® clip versus the endoloop technique for stump closure in laparoscopic appendectomy. Hypothesis Hem o Lok® Clips are effective and safer than Endo Loops for Appendicular Stump Closure in Laparoscopic Appendectomy. Patients will be randomized into one of the two study groups based on there order of arrival in opd all odd number patient will be group A hem o lok clip and all even number patient will be group B endoloop. Patient will be followed for 40 days .in this duration patient will be assessed on day of discharge ,on the day when patient revisit for suture removal ,and 40 day after surgery .In addition patient will be assessed in between if any complications arise and patient revisit opd . |