NCT07129746

Brief Summary

Laparoscopic appendectomy is the standard procedure for acute appendicitis. Among the various steps of the procedure one of the rate limiting step is the ligation of the appendicular stump which can be done using suture material, metallic clips and hem o loks. This study compares the effect the using metallic clips versus suture material in the ligation of appendicular stump in terms of length of surgery and associated intra-operative complications. The patients included will be within the age group of 15-60 years, with BMI of 18-28kg/m2, and with acute appendicitis of upto grade 3. The data will be analyzed using SPSS a p value of \<0.05 will be considered as statistically significant.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 3, 2025

Last Update Submit

August 15, 2025

Conditions

Laparoscopic Appendectomy

Keywords

AppendicitisLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Length of surgery

    The length of surgery will be measured in terms of minutes from the start of the pneumoperitoneum insufflation till the evacuation of the pneumoperitoneum at the conclusion of the surgery.

    Intraoperative

Study Arms (2)

Group A - Patients undergoing metallic clip ligation

ACTIVE COMPARATOR

One of the standard methods of appendicular stump ligation

Device: Metallic clip ligation of the appendicular stump

Group B - Patients undergoing suture material ligation of appendicular stump

EXPERIMENTAL

A feasible testing method with an anticipated increase in the length of surgery

Device: Suture ligation of appendicular stump

Interventions

Metallic clip ligation of the appendicular stumpDEVICE

The group A patients will be having the appendicular stump ligated using the metallic clip, and assessed in terms of length of surgery and associated intra operative complications.

Group A - Patients undergoing metallic clip ligation
Suture ligation of appendicular stumpDEVICE

The appendicular stump in the second arm will be ligated using appropriate suture material and assessed in terms of length of surgery and rate of intraoperative complications.

Group B - Patients undergoing suture material ligation of appendicular stump

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Both genders, within the age bracket of 15 years - 60 years.
  • With a BMI within the range of 18 - 28 kg/m2.
  • With a diagnosis made by a consultant surgeon and the grade of appendicitis upto 3.

You may not qualify if:

  • Patients with long standing comorbidities including chronic liver disease, diabetes mellitus, chronic kidney disease and hemorrhagic disorders.
  • Patients taking anticoagulants, carrier of active cases of Hepatitis B, C and/or HIV.
  • Patients on immunosuppression therapy. Diameter of appendicular stump of more than 10mm, perforated appendix, laparoscopic appendectomy converted to open appendectomy pelvic appendicitis and sub-hepatic appendicitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • Lee JS, Hong TH. Comparison of various methods of mesoappendix dissection in laparoscopic appendectomy. J Laparoendosc Adv Surg Tech A. 2014 Jan;24(1):28-31. doi: 10.1089/lap.2013.0374. Epub 2013 Nov 8.

    PMID: 24206120BACKGROUND

  • Sohn M, Agha A, Bremer S, Lehmann KS, Bormann M, Hochrein A. Surgical management of acute appendicitis in adults: A review of current techniques. Int J Surg. 2017 Dec;48:232-239. doi: 10.1016/j.ijsu.2017.11.028. Epub 2017 Nov 16.

    PMID: 29155250BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Central Study Contacts

MUHAMMAD SAUD IQBAL, MBBS

CONTACT

+923029424346saudiqbal08@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-graduate resident, Principal Investigator

Study Record Dates

First Submitted

August 3, 2025

First Posted

August 19, 2025

Study Start

August 15, 2025

Primary Completion

February 15, 2026

Study Completion

February 20, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations

PA(1)