Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview

NCT ID: NCT05637554

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic clipping appendectomy

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

Group Type ACTIVE_COMPARATOR

Laparoscopic appendectomy using clipping.

Intervention Type PROCEDURE

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

Laparoscopic extracorporeal ligation appendectomy

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic appendectomy using clipping.

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ahmed Hamed Mohamed Elfoly

Resident Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hisham Ali Riad Shaban, Professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Moustafa Mahmoud Ebrahem

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Moustafa Ali Sayed Mahmoud

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Mohamed Ahmed Hamed Mohamed Elfoly, Resident Doctor

Role: CONTACT

+201005126585

References

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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.

Reference Type BACKGROUND
PMID: 34604728 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34085112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29190038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29098432 (View on PubMed)

Other Identifiers

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Laparoscopic appendectomy.

Identifier Type: -

Identifier Source: org_study_id

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