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Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05637554
Collaborator
(none)
40
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic appendectomy using clipping.
  • Procedure: Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview, Prospective Randomized Comparative Study
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Operative time [After procedure completion, an average of 1 hour.]

    Time of the total procedure.

  2. Postoperative complications [Through study completion, an average of 1 year.]

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

Secondary Outcome Measures

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

    Duration of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Ahmed Hamed Mohamed Elfoly, Resident Doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05637554
Other Study ID Numbers:
  • Laparoscopic appendectomy.
First Posted:
Dec 5, 2022
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Appendicitis

Study Results

No Results Posted as of Feb 1, 2023