Tokyo, Sept. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059020) titled 'Development and Validation of a Predictive Scoring System for Bailout Surgery in Laparoscopic Cholecystectomy: A Cluster Randomized Controlled Trial' on Sept. 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Juntendo University Graduate School of Medicine
Condition:
Condition - benign gallbladder diseases
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate whether the application of the Bailout Score in the preoperative assessment of laparoscopic cholecystectomy can accurately predict surgical difficulty and the necessity of bailout procedures.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Presentation of the Bailout Score during preoperative assessment to predict surgical difficulty and the necessity of bailout procedures.
Interventions/Control_2 - Standard preoperative assessment without presentation of the Bailout Score.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Cases of benign gallbladder diseases treated with laparoscopic cholecystectomy between July 1, 2025, and September 30, 2027
Key exclusion criteria - Malignant diseases
Target Size - 800
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 06 Month 01 Day
Date of IRB - 2025 Year 07 Month 01 Day
Anticipated trial start date - 2025 Year 07 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067499
Disclaimer: Curated by HT Syndication.
