Laparoscopic Drainage Versus Interventional Radiology In Management Of Appendicular Abscess : A Randomized Controlled Trial.

This prospective randomized controlled clinical trial included all patients who developed the manifestations of appendicular abscess and referred to the Zagazig University Hospital Emergency Department between January 2020 and February 2022. The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 55342/24.1.2020), and was retrospectively submitted in clinicaltrials.gov in September 2021 (NCT05051683). The study was performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects. Written informed consent was obtained from all participants after explaining to them all the study procedures with its benefits and hazards. Patients ≥16- ≤60 years-old, with appendicular abscess , with early sepsis , no septic shock , ASA I & II , no other pathology and candidate for laparoscopy were deemed eligible for randomization. We excluded patients who were <16- >60 years-old, septic shock, appendicular mass, ASA III , previous abdominal operations, immune compromised patients , patients with immune suppressive therapy, pregnant patients and not candidate for laparoscopy.

Involved patients were simply randomized at a 1:1 ratio to "laparoscopic Group (LG)" or "Interventional Radiology Group (IG)" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the procedure.

The sample size was calculated by using open Epi program depending on the following data ; confidence interval 95%, power of the test 80%, ratio of unexposed/exposed 1, percent of patients with complications after management of appendicular abscess by interventional radiology 15 %, and those managed by laparoscopy 2 % , odds ratio 8.7 , and risk ratio 7.5, So the calculated sample size equal 172 patients divided into two equal group.

Primary and secondary outcomes were fecal fistula , recurrent collection and quality of life in each group after the procedures during the 3-months follow-up period, respectively.

Diagnosis After full history taking ( throbbing pain at right iliac fossa several days ago ) and complete physical examination ( fluctuant high grade fever especially at evening , severe pain & tenderness at right iliac fossa , toxic manifestations), appendicular abscess was clinically suspected and then confirmed by laboratory investigations (complete blood picture (WBC count more than 16000), liver and kidney functions, coagulation profile), radiological imaging (abdominal US or CT abdomen with oral and I.V contrast confirms appendicular abscess) , in laparoscopic group we exclude patients with other pathology after laparoscopic exploration However, the radiology finding was consistent with appendicular abscess.