Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview
Primary Purpose
Appendicitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic appendectomy using clipping.
Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Laparoscopic clipping appendectomy
Laparoscopic extracorporeal ligation appendectomy
Arm Description
This group will undergo laparoscopic clipping of the base of the appendix during laparoscopic appendectomy.
This group will undergo laparoscopic extracorporeal ligation of the base of the appendix during laparoscopic appendectomy.
Outcomes
Primary Outcome Measures
Operative time
Time of the total procedure.
Postoperative complications
All patients will be observed postoperatively for occurrence of complications as leakage, pelvic abscess, wound infection
Secondary Outcome Measures
Hospital stay
Duration of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05637554
Brief Title
Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview
Official Title
Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview, Prospective Randomized Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic clipping appendectomy
Arm Type
Active Comparator
Arm Description
This group will undergo laparoscopic clipping of the base of the appendix during laparoscopic appendectomy.
Arm Title
Laparoscopic extracorporeal ligation appendectomy
Arm Type
Active Comparator
Arm Description
This group will undergo laparoscopic extracorporeal ligation of the base of the appendix during laparoscopic appendectomy.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic appendectomy using clipping.
Intervention Description
Laparoscopic appendectomy using clipping to secure the base of the appendix.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.
Intervention Description
Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.
Primary Outcome Measure Information:
Title
Operative time
Description
Time of the total procedure.
Time Frame
After procedure completion, an average of 1 hour.
Title
Postoperative complications
Description
All patients will be observed postoperatively for occurrence of complications as leakage, pelvic abscess, wound infection
Time Frame
Through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
Hospital stay
Description
Duration of hospital stay
Time Frame
Through the patient's hospital stay, an average of 1 week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Ahmed Hamed Mohamed Elfoly, Resident Doctor
Phone
+201005126585
Email
Mohamed.14223992@med.aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham Ali Riad Shaban, Professor
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moustafa Mahmoud Ebrahem
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moustafa Ali Sayed Mahmoud
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34604728
Citation
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.
Results Reference
background
PubMed Identifier
34085112
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.
Results Reference
background
PubMed Identifier
29190038
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.
Results Reference
background
PubMed Identifier
29098432
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.
Results Reference
background
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Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview
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