Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview

NCT05637554 | Unknown

• 1 other identifier: Laparoscopic appendectomy.
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators aim to compare between laparoscopic clipping and extracorporeal ligation in complicated appendicitis regarding safety, efficacy, operative time, postoperative outcome, hospital stay and complications.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (2)

• Operative time

  Time of the total procedure.

  After procedure completion, an average of 1 hour.

• Postoperative complications

  All patients will be observed postoperatively for occurrence of complications as leakage, pelvic abscess, wound infection

  Through study completion, an average of 1 year.

Secondary Outcomes (1)

• Hospital stay

  Through the patient's hospital stay, an average of 1 week.

Study Arms (2)

Laparoscopic clipping appendectomy

ACTIVE COMPARATOR

This group will undergo laparoscopic clipping of the base of the appendix during laparoscopic appendectomy.

Procedure: Laparoscopic appendectomy using clipping.

Laparoscopic extracorporeal ligation appendectomy

ACTIVE COMPARATOR

This group will undergo laparoscopic extracorporeal ligation of the base of the appendix during laparoscopic appendectomy.

Procedure: Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.

Interventions

Laparoscopic appendectomy using clipping. PROCEDURE

Laparoscopic appendectomy using clipping to secure the base of the appendix.

Laparoscopic clipping appendectomy

Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix. PROCEDURE

Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.

Laparoscopic extracorporeal ligation appendectomy

Eligibility Criteria

• Age: 7 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Acute complicated appendicitis.
• Perforated appendicitis (diagnosed intraoperatively)
• Patients who will undergo laparoscopic appendectomy.

You may not qualify if:

• Patients with straight forward appendectomy.
• Patients who are not fit for laparoscopic appendectomy.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Bessoff KE, Choi J, Wolff CJ, Kashikar A, Carlos GM, Caddell L, Khan RI, Stave CD, Spain DA, Forrester JD. Evidence-based surgery for laparoscopic appendectomy: A stepwise systematic review. Surg Open Sci. 2021 Aug 26;6:29-39. doi: 10.1016/j.sopen.2021.08.001. eCollection 2021 Oct.

  PMID: 34604728 BACKGROUND

• Casas MA, Dreifuss NH, Schlottmann F. High-volume center analysis and systematic review of stump appendicitis: solving the pending issue. Eur J Trauma Emerg Surg. 2022 Jun;48(3):1663-1672. doi: 10.1007/s00068-021-01707-y. Epub 2021 Jun 3.

  PMID: 34085112 BACKGROUND

• Mannu GS, Sudul MK, Bettencourt-Silva JH, Cumber E, Li F, Clark AB, Loke YK. Closure methods of the appendix stump for complications during laparoscopic appendectomy. Cochrane Database Syst Rev. 2017 Nov 13;11(11):CD006437. doi: 10.1002/14651858.CD006437.pub3.

  PMID: 29190038 BACKGROUND

• Delibegovic S, Mehmedovic Z. The influence of the different forms of appendix base closure on patient outcome in laparoscopic appendectomy: a randomized trial. Surg Endosc. 2018 May;32(5):2295-2299. doi: 10.1007/s00464-017-5924-z. Epub 2017 Nov 2.

  PMID: 29098432 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Hisham Ali Riad Shaban, Professor

  Assiut University

  PRINCIPAL INVESTIGATOR

• Moustafa Mahmoud Ebrahem

  Assiut University

  PRINCIPAL INVESTIGATOR

• Moustafa Ali Sayed Mahmoud

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Ahmed Hamed Mohamed Elfoly, Resident Doctor

CONTACT

+201005126585; Mohamed.14223992@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Model Details: Participants will be divided randomly into two groups, in the first group the investigators will use clipping in securing the base of the appendix but in other groups investigators will use extracorporeal ligation.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 5, 2022
• Study Start: February 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01