Comparison Between Metallic Clip Ligation and Suture Ligation of Appendicular Stump in Laparoscopic Appendectomy

August 15, 2025 updated by: MUHAMMAD SAUD IQBAL, Jinnah Hospital

Comparison Between Metallic Clip Ligation and Suture Ligation of Appendicular Stump in Laparoscopic Appendectomy, a Randomized Control Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with long standing comorbidities including chronic liver disease, diabetes mellitus, chronic kidney disease and hemorrhagic disorders.
  2. Patients taking anticoagulants, carrier of active cases of Hepatitis B, C and/or HIV.
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A - Patients undergoing metallic clip ligation
One of the standard methods of appendicular stump ligation
Device: Metallic clip ligation of the appendicular stump
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.
Experimental: Group B - Patients undergoing suture material ligation of appendicular stump
A feasible testing method with an anticipated increase in the length of surgery
Device: Suture ligation of appendicular stump
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of surgery
Time Frame: Intraoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2025

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

February 20, 2026

Study Registration Dates

First Submitted

August 3, 2025

First Submitted That Met QC Criteria

August 15, 2025

First Posted (Actual)

August 19, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Jinnah Hospital Lahore

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The individual patient data will not be shared with other researchers on the basis of keeping confidentiality of the patients since this is a small center localized study. The matter was discussed with the ethical review board and the study was agreed upon under the aforementioned condition.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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