Open to Laparoscopic Reverse Conversion of Perforated Appendicitis

NCT05283733 | Completed DMC

• 1 other identifier: ZUH 235
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

laparoscopic; appendectomy; reverse conversion; reoperation; intraabdominal abscesses

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• The hospital length of stay

  up to 3 months

• the operative time

  Intraoperative

Study Arms (2)

group A

EXPERIMENTAL

the group who was subjected to the reverse conversion technique

Procedure: reverse conversion technique

group B

NO INTERVENTION

the control group who was completed by open technique

Interventions

reverse conversion technique PROCEDURE

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

Also known as: laparoscopic lavage

group A

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Egypt

Location

MeSH Terms

Conditions

Sepsis; Abdominal Abscess

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Abscess; Suppuration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 17, 2022
• Study Start: January 18, 2018
• Primary Completion: December 15, 2021
• Study Completion: December 25, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

EG (1)