Open to Laparoscopic Reverse Conversion of Perforated Appendicitis

Not Applicable

Completed

• Conditions: Acute Appendicitis With Rupture; Sepsis; Laparoscopic Surgery; Abdominal Abscess
• Interventions: Procedure: reverse conversion technique

• Registration Number: NCT05283733
• Lead Sponsor: Zagazig University

Brief Summary

A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in management of Acute Perforated Appendicitis

Detailed Description

Introduction: Acute appendicitis (AA), a frequent intra-abdominal surgical pathology, necessitates a thorough awareness of its symptoms, examination, diagnosis, and total surgical management. The surgical approach to AA is appendectomy; nevertheless, the medical literature continues to argue the merits of open vs laparoscopic surgery. As with other laparoscopic surgical techniques, the literature reports lower discomfort, earlier resumption of oral feeding and shorter hospital stay following laparoscopic appendectomy (LA) as compared to open appendectomy (OA). Additionally, laparoscopy has some drawbacks such as greater cost and lengthier operating durations as compared to open surgery. The goal of this clinical study: was to compare open appendectomy versus laparoscopic conversion from open (reverse conversion) for the treatment of acute perforated appendicitis in our setting. Patients and procedures: 426 patients had perforated appendectomy and divided between two groups: group A (interventional) 213 patients who were subjected to the reverse conversion technique and group B (control)213 patients who were operated by the open technique. The key end goals for comparing both groups were the rates of intraabdominal abscess, rates of wound infection, rates of ileus and rates of reoperation. The hospital length of stay and the operative time were used as secondary end goals for comparison.

Study Timeline

• Study Start: 2018-01-18
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-25
• Study First Submitted: 2022-02-18
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-16
• Last Update Submitted: 2022-03-16
• Study First Posted: 2022-03-17
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

Inclusion Criteria

• symptoms consistent with acute perforated appendicitis,
• had ultrasound or computed tomography (CT) evidence of acute perforated appendicitis,
• ages ranging from 16 to 65 years.

Exclusion Criteria

• radiological evidence of appendicular mass,
• septic shock or multi-organ failure (MOF) at presentation,
• Diabetes Mellitus (DM), renal failure, morbid obesity
• recent (6-month) history of thromboembolic disease
• immunomodulators,
• a history of inflammatory bowel disease (IBD),
• postoperative pathological report of the removed appendix revealed carcinoid or Crohn's disease,
• American Society of Anesthesiology (ASA) classification more than II.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	reverse conversion technique	the group who was subjected to the reverse conversion technique

Primary Outcome Measures

Name	Time	Method
the rates of intraabdominal abscess	3 months post operative	rates of complications
rates of wound infection	3 months post operative	rates of complications
rates of ileus	Baseline (Hospital admission)
rates of reoperation	3 months post operative

Secondary Outcome Measures

Name	Time	Method
the operative time	Intraoperative	Time of performing the procedures
The hospital length of stay	up to 3 months	the length of hospital stay

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Egypt