Clinical Trial: A Randomized Controlled Trial of Single-Incision Laparoscopic Appendectomy via Pfannenstiel versus Umbilical Incision for Acute Appendicitis (Japan)

Tokyo, Sept. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062797) titled 'A Randomized Controlled Trial of Single-Incision Laparoscopic Appendectomy via Pfannenstiel versus Umbilical Incision for Acute Appendicitis' on Sept. 3.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Nippon Medical School

Condition: Condition - Acute appendicitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to compare Pfannenstiel and umbilical incisions for single-incision laparoscopic appendectomy in patients with acute appendicitis and to evaluate the efficacy and safety of the two approaches, with postoperative pain as the primary outcome. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single-incision laparoscopic appendectomy via a Pfannenstiel incision Interventions/Control_2 - Single-incision laparoscopic appendectomy via an umbilical incision

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 18 years or older. Patients diagnosed with acute appendicitis and considered eligible for single-incision laparoscopic appendectomy. Patients who have received an explanation of the study using the written informed consent document and provided written informed consent themselves, or, when the patient is unable to provide consent, whose legally acceptable representative has provided written informed consent. Key exclusion criteria - Patients with suspected appendiceal tumor or appendiceal cancer before surgery. Pregnant patients. Patients with severe obesity (BMI 35 kg/m2 or higher). Patients in whom laparoscopic surgery is strongly considered difficult because of a history of abdominal surgery or other reasons. Patients considered unsuitable for participation in this study by the principal investigator or study investigators. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 29 Day Date of IRB - 2026 Year 07 Month 27 Day Anticipated trial start date - 2026 Year 09 Month 04 Day Last follow-up date - 2027 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071869

Disclaimer: Curated by HT Syndication.