Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062182) titled 'A Progressive Tubeless Day Surgery Mode for Laparoscopic Adrenal Tumors with Preoperative Bleeding Risk Stratification' on July 9.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Xuzhou Cancer Hospital

Condition: Condition - Adrenal Tumors, Adrenal Adenoma, Functional Adrenal Mass Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To establish a standardized progressive tubeless day surgery system for laparoscopic adrenal tumors based on self-developed preoperative stratified bleeding risk control criteria. We aim to verify the clinical safety and recovery advantages of risk-stratified perioperative ERAS management, compare the differences in perioperative indicators between low and high bleeding risk groups, and evaluate the health economic benefits of the 48-hour tubeless day surgery model for adrenal tumors. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Progressive tubeless laparoscopic adrenal tumor resection combined with 48-hour ERAS day-surgery protocol for patients satisfying all general inclusion criteria and seven low intraoperative bleeding risk standards. No drainage tube is placed after operation, and standardized short-stay perioperative management is adopted. Interventions/Control_2 - Conventional laparoscopic adrenal tumor resection with routine placement of postoperative drainage tube for patients meeting all general inclusion criteria but failing to satisfy the seven low intraoperative bleeding risk standards. Standard ordinary inpatient management is adopted instead of tubeless treatment and 48-hour day-surgery mode.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Imaging-confirmed adrenal space-occupying lesions, scheduled for retroperitoneal laparoscopic adrenal tumor resection; Complete clinical and intraoperative data available to assess seven intraoperative bleeding risk indicators; Patients and their families provide informed consent and voluntarily cooperate with full-course follow-up. Key exclusion criteria - Patients undergoing open or robotic adrenal tumor resection; Severe preoperative coagulation disorders with inability to discontinue anticoagulant/antiplatelet drugs; Combined end-stage cardiac, pulmonary, hepatic or renal failure intolerant to short-term enhanced recovery management; Cases with missing key clinical or intraoperative data, refusal of follow-up, or voluntary withdrawal during the study. Target Size - 360

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 03 Day Anticipated trial start date - 2026 Year 07 Month 15 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071157

Disclaimer: Curated by HT Syndication.