| CTRI Number |
CTRI/2024/03/064477 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare 3 surgical devices plastic clip, commercially available loops and hand made knot technique to secure appendiceal base in terms of surgical time, cost, safety ,surgeons preference and technical ease |
|
Scientific Title of Study
|
Comparison of stump ligation time, safety and cost-effectiveness between HOLP, Endo loop and Roader’s knot for appendectomy in uncomplicated acute appendicitis: a randomized controlled trial at a single centre |
| 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 Agrawal Kavita Khemchand |
| Designation |
Assistant Professor |
| Affiliation |
Dr.B.R.Ambedkar State Institute of Medical Sciences, Mohali |
| Address |
Department of general surgery
Room no 103
Civil Hospital Sector 56 A
Mohali
Department of general surgery
Room no 103
Civil Hospital Sector 56 A
Mohali
Rupnagar
PUNJAB
160055
India |
| Phone |
7087438617 |
| Fax |
|
| Email |
drkavitaagrawal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Agrawal Kavita Khemchand |
| Designation |
Assistant Professor |
| Affiliation |
Dr.B.R.Ambedkar State Institute of Medical Sciences, Mohali |
| Address |
Department of general surgery
Room no 103
Civil Hospital Sector 56 A
Mohali
Department of general surgery
Room no 103
Civil Hospital Sector 56 A
Mohalii
Rupnagar
PUNJAB
160055
India |
| Phone |
7087438617 |
| Fax |
|
| Email |
drkavitaagrawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Agrawal Kavita Khemchand |
| Designation |
Assistant Professor |
| Affiliation |
Dr.B.R.Ambedkar State Institute of Medical Sciences, Mohali |
| Address |
Department of general surgery
Room no 103
Civil Hospital Sector 56 A
Mohali
Department of general surgery
Room no 103
Civil Hospital Sector 56 A
Mohali
Rupnagar
PUNJAB
160055
India |
| Phone |
7087438617 |
| Fax |
|
| Email |
drkavitaagrawal@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSIR-ASPIRE, Anusandhan bhawan, 2 Rafi Ahmed kidwai Marg New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
CSIR-ASPIRE |
| Address |
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 Agrawal Kavita Khemchand |
Dr. B.R.Ambedkar State Institute Of Medical Sciences |
Department of general surgery
Room no 103
Civil Hospital Sector 56 A
Mohali
Rupnagar
PUNJAB |
7087438617
drkavitaagrawal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
catgut endoloop |
stump ligation by catgut endoloop |
| Intervention |
hemlock polymer clips |
stump ligation by hemlock polymer clips |
| Comparator Agent |
stump ligation time, cost effectiveness, safety |
to compare stump ligation time, cost effectiveness, safety in all 3 intervention group in laparoscopic appendectomy |
| Intervention |
vicryl suture knot |
stump ligation by Roaders knot |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
2. Patients scheduled to undergo emergency laparoscopic appendectomy for acute uncomplicated appendicitis |
|
| ExclusionCriteria |
| Details |
1. Patient having preoperative evidence of perforated or gangrenous appendicitis
2. Patients with friable and unhealthy base
3. Patients in whom technique of stump closure will be changed due to intraoperative difficulty
4. Patients who get converted to open appendectomy
5. Patients in whom another device such as metal clips, intracorporeal suturing or stapler used as stump closure method
6. Patients in whom procedure is performed by a surgeon that does not belong to the investigator/co-investigator s of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare total stump ligation time between HOLP clip, Roader’s knot and Endoloop for the closure of the appendix base during laparoscopic appendectomy |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a) Cost effectiveness of the technique |
24 months |
| b) Grading of technical ease of the procedure by the operating surgeon using 5-point Likert scale questionnaire |
24 months |
| c) Any operative complication using Clavin-Dindo classification |
24 month |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
03/06/2024 |
| 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
|
This is a prospective three arm randomized controlled trial comparing HOLP, Endo loop and Roaders knot in terms of total stump ligation time, cost and complications for appendectomy in uncomplicated acute appendicitis. We are measuring stump ligation time along with total operative time. The study will also grade technical ease of the procedure by the operating surgeon using 5-point Likert`s scale questionnaire
Future plan: To establish method of choice for stump closure in laparoscopic appendectomy and to increase familiarity amongst surgeons regarding different techniques of laparoscopic appendicular stump ligation. |