| CTRI Number |
CTRI/2026/03/106433 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the safety and effectiveness of laparoscopic surgery for complicated appendicitis in adolescents and adults |
|
Scientific Title of Study
|
Feasibility, Safety and Effectiveness of Laparoscopic Appendectomy for Complicated Acute Appendicitis in Adolescents and Adults– A Prospective interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHISHEK KUMAR |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pardesh University of Medical Sciences Saifai, Etawah |
| Address |
Department of General Surgery , Uttar Pardesh University of Medical Sciences Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9759577636 |
| Fax |
|
| Email |
abhikr222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar |
| Designation |
Professor |
| Affiliation |
Uttar Pardesh University of Medical Sciences Saifai, Etawah |
| Address |
Department of General Surgery , Uttar Pardesh University of Medical Sciences Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9953177755 |
| Fax |
|
| Email |
dranilsjhdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar |
| Designation |
Professor |
| Affiliation |
Uttar Pardesh University of Medical Sciences Saifai, Etawah |
| Address |
Department of General Surgery , Uttar Pardesh University of Medical Sciences Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9953177755 |
| Fax |
|
| Email |
dranilsjhdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funded academic study in Uttar Pardesh Institute of Medical Sciences Saifai Etawah Uttar Pardesh ,India 206130 |
|
|
Primary Sponsor
|
| Name |
Uttar Pardesh Institute of Medical Sciences |
| Address |
Uttar Pardesh Institute of Medical Sciences , Saifai , Etawah PINCODE -206130 |
| Type of Sponsor |
Government medical college |
|
|
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 Abhishek kumar |
Uttar Pardesh Institute of Medical Sciences |
Department of General Surgery 2nd floor Old OPD building Uttar Pardesh Institute of Medical Sciences
Etawah
UTTAR PRADESH |
9759577636
abhikr222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe uttar pardesh university of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic Appendectomy |
Laparoscopic appendectomy performed for patients diagnosed with complicated appendicitis (gangrenous , perforated appendicitis , appendicular abscess , or peritonitis ) along with standard preoperative and postoperative antibiotic therapy as per institutional protocol . |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1-Adolescents and Adult aged 14 years and above
2-Patient diagnosed with complicated acute appendicitis (Gangrenous appendicitis , perforated appendicitis , appendicular abscess , appendicular peritonitis ) based on ultrasonography , contrast enhanced computed tomography or intraoperative findings.
|
|
| ExclusionCriteria |
| Details |
1-Age less than 14 years
2-Uncomplicated acute appendicitis
3-Appendicular lump managed conservatively
4-Suspected appendicular or caecal malignancy
5- pregnant females
6- patient unfit for general anesthesia
7- patient not willing to participate or not providing consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative complications following laparoscopic appendectomy including
1-intraabdominal abscess
2-port site infection
3-conversion to open appendectomy
4intraopertaive complications |
Postoperative complications following laparoscopic appendectomy assessed at 0 day ,1 week ,4 week including
1-intraabdominal abscess
2-port site infection
3-conversion to open appendectomy
4intraopertaive complications |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean operative time |
During surgery |
| length of hospital stay |
During hospital admission |
| Time to return normal daily activity |
within 3 months follow up |
| Overall recovery time |
3 months post surgery |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
30/03/2026 |
| 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="1"
Months="6"
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
|
Acute appendicitis is one of the most common surgical emergencies worldwide. Complicated acute appendicitis includes gangrenous appendicitis, perforated appendicitis, appendicular abscess and appendicular peritonitis. Open appendectomy has traditionally been the standard surgical treatment for complicated appendicitis. However, laparoscopic appendectomy has increasingly been used due to potential benefits such as reduced postoperative pain, shorter hospital stay and faster recovery.
This prospective single arm interventional study aims to evaluate the feasibility, safety and effectiveness of laparoscopic appendectomy in adolescents and adults aged 14 years and above diagnosed with complicated acute appendicitis. A total of 64 patients meeting the inclusion criteria will be enrolled. All eligible patients will undergo laparoscopic appendectomy under general anesthesia along with standard perioperative antibiotic therapy as per institutional protocol.
Primary outcome measures include postoperative intra abdominal abscess, port site infection, intraoperative complications and conversion to open appendectomy within 30 days after surgery. Secondary outcome measures include operative time, length of hospital stay and overall recovery time assessed up to 3 months follow up.
The findings of this study will help determine whether laparoscopic appendectomy is a safe and effective approach for managing complicated acute appendicitis in a tertiary care teaching hospital setting. |