Clinical trial NCT05283733: Open to Laparoscopic Reverse Conversion of Perforated Appendicitis
Official title: A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in Management of Acute Perforated Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery
Acute Appendicitis With Rupture
Sepsis
Abdominal Abscess
Keywords: laparoscopic
appendectomy
reverse conversion
reoperation
intraabdominal abscesses
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-03-17
Enrollment: 426
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the rates of intraabdominal abscess
timeFrame: 3 months post operative
measure: rates of wound infection
timeFrame: 3 months post operative
measure: rates of ileus
timeFrame: Baseline (Hospital admission)
measure: rates of reoperation
timeFrame: 3 months post operative
Secondary outcomes:
measure: The hospital length of stay
timeFrame: up to 3 months
measure: the operative time
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
References: