Skip to main content
OpenTrials
Completed

NCT Number: NCT07281612

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

AIMS

Muzaffarabad, AJK/Punjab, 60000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand-made Extracorporeal Knotting

Procedure

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

Clip Closure

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

Primary outcomes

  1. Post operative ileus

    Time frame: within 48 hours of surgery

    Postoperative ileus defined as absence of bowel movement, passage of flatus, or audible bowel sounds up to 48 hours after surgery

  2. Intra abdominal infection

    Time frame: within 15 days of surgery

    Intra-abdominal infection defined as presence of fever, abdominal pain, or systemic symptoms confirmed by CT scan showing intra-abdominal abscess or infection requiring medical or surgical treatment.

Sponsors and collaborators

Lead sponsor

Punjab Health Care Commission

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Hand-made Extracorporeal Knotting Versus Clip for Stump Closure in Laparoscopic Appendectomy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.