Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05637554
• Other study ID #: Laparoscopic appendectomy.
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: January 2024

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Mohamed Ahmed Hamed Mohamed Elfoly, Resident Doctor
• Phone: +201005126585
• Email: Mohamed.14223992[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appendicitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Time of the total procedure.	After procedure completion, an average of 1 hour.
Primary	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	Hospital stay	Duration of hospital stay	Through the patient's hospital stay, an average of 1 week.