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

NCT07281612 | Completed Early Phase 1

• 1 other identifier: AIMS-APP-Knot-vs-Clip
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicectomy

Keywords

Appendicectomy; stump closure; knotting; clip; surgery; ileus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Hand Made Knot Group

EXPERIMENTAL

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

Arm 2

ACTIVE COMPARATOR

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

Interventions

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

Hand Made Knot Group

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

Arm 2

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Punjab Health Care Commission: lead

Study Sites (1)

AIMS

Muzaffarabad, AJK/Punjab, 60000, Pakistan

Location

MeSH Terms

Conditions

Ileus

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Haseeb Ul Hassan, MBBS

  AIMS Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: March 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-03

Locations

PA (1)