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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2026-02-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Laparoscopic Appendectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A - Patients undergoing metallic clip ligation

One of the standard methods of appendicular stump ligation

Group Type ACTIVE_COMPARATOR

Metallic clip ligation of the appendicular stump

Intervention Type DEVICE

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 B - Patients undergoing suture material ligation of appendicular stump

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

Group Type EXPERIMENTAL

Suture ligation of appendicular stump

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No