Open to Laparoscopic Reverse Conversion of Perforated Appendicitis

Sepsis Clinical Trial

— reverse  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283733
• Other study ID #: ZUH 235
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: December 25, 2021

Study information

• Verified date: March 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: December 25, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• reverse conversion technique
converting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rates of intraabdominal abscess	rates of complications	3 months post operative
Primary	rates of wound infection	rates of complications	3 months post operative
Primary	rates of ileus		Baseline (Hospital admission)
Primary	rates of reoperation		3 months post operative
Secondary	The hospital length of stay	the length of hospital stay	up to 3 months
Secondary	the operative time	Time of performing the procedures	Intraoperative