Hand-made Extracorporeal Knotting Versus Clip for Stump Closure in Laparoscopic Appendectomy

NCT ID: NCT07281612

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-11-30

Brief Summary

Acute appendicitis is one of the most common causes of emergency abdominal surgery. Laparoscopic appendectomy is now widely used because it offers advantages such as shorter hospital stay, less postoperative pain, and better cosmetic outcomes. However, the optimal technique for appendiceal stump closure remains unclear, and different methods such as endoloops, clips, sutures, and staplers are currently used in clinical practice.

This randomized controlled trial will compare two commonly used stump closure techniques during laparoscopic appendectomy: hand-made extracorporeal knotting and polymeric clip application. Participants will be randomly assigned in a 1:1 ratio to either group. The study outcomes include failure of technique, postoperative ileus, and intra-abdominal infection within 15 days after surgery.

The aim of this study is to determine whether hand-made extracorporeal knotting is more effective than clip application in reducing postoperative complications related to appendiceal stump closure.

Detailed Description

Acute appendicitis is a major cause of acute abdomen and a frequent indication for emergency surgery. Laparoscopic appendectomy has become the preferred surgical approach due to advantages such as reduced postoperative pain, quicker recovery, lower wound infection rates, and improved cosmetic outcomes. Despite technical advancements, appendiceal stump leakage remains a serious postoperative concern, potentially resulting in intra-abdominal sepsis and reoperation.

A variety of appendiceal stump closure techniques are in use, including endoloops, sutures, staplers, and clips. Both hand-made extracorporeal knotting and polymeric nonabsorbable clips (Hem-o-lok®) are commonly employed and considered safe. Hand-made extracorporeal knotting has potential advantages of lower cost and usability in resource-limited settings, but the optimal closure technique remains controversial and evidence is limited.

This study is designed as a single-center, prospective, parallel-group randomized controlled trial conducted at Abbas Institute of Medical Sciences, Muzaffarabad. A total of 190 patients aged 10-70 years presenting with acute appendicitis and undergoing laparoscopic appendectomy will be enrolled. After diagnostic laparoscopy and confirmation of eligibility, participants will be randomized by simple lottery method into one of two groups:

Intervention Group: appendiceal stump closure using hand-made extracorporeal knotting (modified Tayside knot), with two knots applied.

Comparator Group: appendiceal stump closure using a nonabsorbable polymeric Hem-o-lok® clip.

Demographic variables, comorbidities, stump diameter, and operative time will be recorded. Outcomes will be assessed intraoperatively and postoperatively, with follow-up continuing until postoperative day 15. The primary outcome is intra-abdominal infection within 15 days. Secondary outcomes include failure of technique during surgery and postoperative ileus.

Statistical analysis will be performed using SPSS software. Categorical variables will be analyzed using a chi-square test, and continuous variables will be summarized as mean ± standard deviation. A p-value ≤ 0.05 will be considered statistically significant.

The findings of this trial may help determine whether hand-made extracorporeal knotting provides superior clinical outcomes or cost advantages compared to polymeric clips, and may guide standardization of appendiceal stump closure techniques in laparoscopic appendectomy, particularly in low-resource surgical settings.

Conditions

Appendicectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hand Made Knot Group

Appendiceal stump closure using hand-made extracorporeal knotting (modified Tayside knot). Two extracorporeal knots will be applied to secure the appendiceal stump during laparoscopic appendectomy.

Group Type: EXPERIMENTAL

Hand-made Extracorporeal Knotting

Intervention Type: PROCEDURE

Appendiceal stump closure performed using a hand-made extracorporeal knot (modified Tayside knot technique). Two knots will be applied. Used during laparoscopic appendectomy

Arm 2

Appendiceal stump closure using a nonabsorbable polymeric Hem-o-lok® clip. One clip is applied at the appendiceal stump and a second clip may be added 2-3 mm above the first if needed

Group Type: ACTIVE_COMPARATOR

Clip Closure

Intervention Type: PROCEDURE

Appendiceal stump closure performed using a nonabsorbable polymeric Hem-o-lok® clip system (Teleflex Medical, USA). The clip is applied to the stump during laparoscopic appendectomy

Interventions

Hand-made Extracorporeal Knotting

Appendiceal stump closure performed using a hand-made extracorporeal knot (modified Tayside knot technique). Two knots will be applied. Used during laparoscopic appendectomy

Intervention Type: PROCEDURE

Clip Closure

Appendiceal stump closure performed using a nonabsorbable polymeric Hem-o-lok® clip system (Teleflex Medical, USA). The clip is applied to the stump during laparoscopic appendectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 10 to 70 years
• Either sex
• Clinical diagnosis of acute appendicitis with Alvarado score >6
• ASA physical status I-III
• Planned laparoscopic appendectomy

Exclusion Criteria

• Patient request for open appendectomy
• Complicated appendicitis (perforation, appendicular abscess, or appendicular mass)
• Local or diffuse peritonitis
• Friable or necrotic appendix base
• Pelvic inflammatory disease

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Punjab Health Care Commission

OTHER

Sponsor Role: lead

Responsible Party

Haseeb Ul Hassan

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haseeb Ul Hassan, MBBS

Role: PRINCIPAL_INVESTIGATOR

AIMS Institute

Locations

AIMS

Muzaffarabad, AJK/Punjab, Pakistan

Countries

Pakistan

Other Identifiers

AIMS-APP-Knot-vs-Clip

Identifier Type: -

Identifier Source: org_study_id