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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05283733
Other study ID # ZUH 235
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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