reverse: Open to Laparoscopic Reverse Conversion of Perforated Appendicitis

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT05283733

Collaborator

(none)

426

Enrollment

Location

Arms

47.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Surgery Acute Appendicitis With Rupture Sepsis Abdominal Abscess	Procedure: reverse conversion technique	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

426 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 18, 2018

Actual Primary Completion Date :

Dec 15, 2021

Actual Study Completion Date :

Dec 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group A the group who was subjected to the reverse conversion technique	Procedure: reverse conversion technique converting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis Other Names: laparoscopic lavage
No Intervention: group B the control group who was completed by open technique

Arm

Intervention/Treatment

Experimental: group A

the group who was subjected to the reverse conversion technique

Procedure: reverse conversion technique

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

Other Names:

laparoscopic lavage

No Intervention: group B

the control group who was completed by open technique

Outcome Measures

Primary Outcome Measures

the rates of intraabdominal abscess [3 months post operative]
rates of complications
rates of wound infection [3 months post operative]
rates of complications
rates of ileus [Baseline (Hospital admission)]
rates of reoperation [3 months post operative]

Secondary Outcome Measures

The hospital length of stay [up to 3 months]
the length of hospital stay
the operative time [Intraoperative]
Time of performing the procedures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.