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

A Randomized Controlled Trial Comparing 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.

Study Overview

• Status: Completed
• Conditions: Appendicectomy
• Intervention / Treatment: Procedure: Hand-made Extracorporeal Knotting; Procedure: Clip 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.

• Study Type: Interventional
• Enrollment (Actual): 190
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • AJK/Punjab
    • Muzaffarabad, AJK/Punjab, Pakistan, 60000
      • AIMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative ileus	Postoperative ileus defined as absence of bowel movement, passage of flatus, or audible bowel sounds up to 48 hours after surgery	within 48 hours of surgery
Intra abdominal infection	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.	within 15 days of surgery

Collaborators and Investigators

• Sponsor: Punjab Health Care Commission
• Investigators: Principal Investigator: Haseeb Ul Hassan, MBBS, AIMS Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: surgery; ileus; clip; stump closure; Appendicectomy; knotting
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Obstruction; Ileus; Surgical Equipment; Equipment and Supplies; Surgical Instruments
• Other Study ID Numbers: AIMS-APP-Knot-vs-Clip

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At this time, plans for sharing individual participant data (IPD) have not been finalized. Data access may be limited due to patient privacy considerations, lack of a secure data-sharing framework, and institutional policies regarding confidentiality. If future sharing becomes possible, a detailed plan will be provided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No