Open to Laparoscopic Reverse Conversion of Perforated Appendicitis (reverse)

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

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

Study Overview

• Status: Completed
• Conditions: Sepsis; Laparoscopic Surgery; Abdominal Abscess; Acute Appendicitis With Rupture
• Intervention / Treatment: Procedure: reverse conversion technique

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 Type: Interventional
• Enrollment (Actual): 426
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; the group who was subjected to the reverse conversion technique	Procedure: reverse conversion technique; converting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis; Other Names: laparoscopic lavage
No Intervention: group B; the control group who was completed by open technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rates of intraabdominal abscess	rates of complications	3 months post operative
rates of wound infection	rates of complications	3 months post operative
rates of ileus		Baseline (Hospital admission)
rates of reoperation		3 months post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The hospital length of stay	the length of hospital stay	up to 3 months
the operative time	Time of performing the procedures	Intraoperative

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 25, 2021

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: reoperation; laparoscopic; appendectomy; reverse conversion; intraabdominal abscesses
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Inflammation; Wounds and Injuries; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Suppuration; Cecal Diseases; Intraabdominal Infections; Rupture; Abscess; Appendicitis; Abdominal Abscess
• Other Study ID Numbers: ZUH 235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No