Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview

Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview, Prospective Randomized Comparative Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Appendicitis
• Intervention / Treatment: Procedure: Laparoscopic appendectomy using clipping.; Procedure: Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.

Detailed Description

Appendectomy has become one of the most commonly performed emergency abdominal operations since it's description by McBurney in the 1890s. Since laparoscopic appendectomy was first described in 1983, there is an increase in the general trend towards performing this surgery using laparoscopy instead of open technique as this approach shows better pain score, lesser use of analgesics, less operative complications, better post operative recovery, less hospital stay and rapid return to normal work.

There are many methods for securing the base of the appendix, some of which are expensive others are not available or technically demanding. In this study the investigators aim to compare between extracorporeal ligation and clipping techniques regarding feasibility, safety, efficacy, operative time, postoperative outcome and complications especially in complicated appendicitis.

AS management of complicated appendicitis laparoscopically is possible, secure and can lead to a little occurrence of infectious complications, fewer post-operative pain, quick revival and improve cosmesis so the investigators will do a prospective clinical trial comparative study between two common techniques to determine the best one in management of complicated cases.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Ahmed Hamed Mohamed Elfoly, Resident Doctor; Phone Number: +201005126585; Email: Mohamed.14223992@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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
Active Comparator: Laparoscopic clipping appendectomy; This group will undergo laparoscopic clipping of the base of the appendix during laparoscopic appendectomy.	Procedure: Laparoscopic appendectomy using clipping.; Laparoscopic appendectomy using clipping to secure the base of the appendix.
Active Comparator: Laparoscopic extracorporeal ligation appendectomy; 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.; Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	Duration of hospital stay	Through the patient's hospital stay, an average of 1 week.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hisham Ali Riad Shaban, Professor, Assiut University; Principal Investigator: Moustafa Mahmoud Ebrahem, Assiut University; Principal Investigator: Moustafa Ali Sayed Mahmoud, Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: Laparoscopic appendectomy.

Drug and device information, study documents

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