Open to Laparoscopic Reverse Conversion of Perforated Appendicitis

NCT ID: NCT05283733

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-18
• Study Completion Date: 2021-12-25

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.

Conditions

Laparoscopic Surgery; Acute Appendicitis With Rupture; Sepsis; Abdominal Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

group A

the group who was subjected to the reverse conversion technique

Group Type: EXPERIMENTAL

reverse conversion technique

Intervention Type: PROCEDURE

converting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis

group B

the control group who was completed by open technique

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

reverse conversion technique

converting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis

Intervention Type: PROCEDURE

Other Intervention Names

laparoscopic lavage

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mohamed lotfy

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zagazig University

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

ZUH 235

Identifier Type: -

Identifier Source: org_study_id