Skip to main content
OpenTrials
Completed

NCT Number: NCT05283733

Open to Laparoscopic Reverse Conversion of Perforated Appendicitis

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University

Zagazig, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

reverse conversion technique

Procedure

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

Other names: laparoscopic lavage

Primary outcomes

  1. the rates of intraabdominal abscess

    Time frame: 3 months post operative

    rates of complications

  2. rates of wound infection

    Time frame: 3 months post operative

    rates of complications

  3. rates of ileus

    Time frame: Baseline (Hospital admission)

  4. rates of reoperation

    Time frame: 3 months post operative

Secondary outcomes

  1. The hospital length of stay

    Time frame: up to 3 months

    the length of hospital stay

  2. the operative time

    Time frame: Intraoperative

    Time of performing the procedures

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Acronym: reverse

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2022
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.