Tokyo, July 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062337) titled 'Safety and efficacy of tubeless laparoscopic surgery for adrenal tumors' on July 25.
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 - Benign adrenal tumors (non-functional adenoma, aldosteronoma, pheochromocytoma, myelolipoma) requiring retroperitoneal laparoscopic resection
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the safety and efficacy of stratified tubeless protocol versus routine drainage placement for retroperitoneal laparoscopic resection of benign adrenal tumors in a dual-center prospective observational cohort, by analyzing perioperative recovery indicators and complication rates. This study is Phase 1 of a two-stage tubeless adrenal research project under unified ethical approval.
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Arm1: Tubeless protocol: laparoscopic adrenal resection without drainage tube, standardized hemostasis and vascular clipping, postoperative CT review.
Arm2: Conventional drainage: laparoscopic adrenal resection with routine indwelling retroperitoneal drainage tube.
Interventions/Control_2 - Arm1: Tubeless protocol: laparoscopic adrenal resection without drainage tube, standardized hemostasis and vascular clipping, postoperative CT review.
Arm2: Conventional drainage: laparoscopic adrenal resection with routine indwelling retroperitoneal drainage tube.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Unilateral benign adrenal tumor confirmed by preoperative imaging;
2. Receiving retroperitoneal laparoscopic adrenal tumor resection via 3-port or 4-port approach;
3. Complete written informed consent obtained;
4. For tubeless group participants, all the following nine low-risk criteria must be fully satisfied:
(1) Age less than 61 years;
(2) Maximum tumor diameter less than 3.0 cm;
(3) Adrenal parenchyma and central adrenal vein occluded with locking clips;
(4) No surgical field adhesion or fat saponification;
(5) Intraoperative blood loss less than 80 mL;
(6) No intraoperative injury to peritoneum, kidney or other adjacent organs;
(7) Thorough intraoperative hemostasis without obvious wound exudation;
(8) No bleeding along trocar puncture tracts;
(9) No postoperative anticoagulant administration within 12 hours after surgery.
Patients who do not meet all nine tubeless criteria will be allocated to the conventional drainage group.
Key exclusion criteria - 1. Preexisting coagulation disorders;
2. Oral anticoagulant medication taken within one week before surgery;
3. Cognitive dysfunction, communication disorders or severe psychiatric disorders unable to cooperate with treatment and follow-up;
4. Severe vital organ insufficiency or advanced systemic disease incompatible with general anesthesia;
5. Bilateral adrenal tumors;
6. Conversion to open surgery intraoperatively.
Target Size - 86
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 08 Month 01 Day
Date of IRB - 2025 Year 05 Month 25 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2026 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071334
Disclaimer: Curated by HT Syndication.
