NCT05675124

Comparison of Needlescopic vs. Conventional Laparoscopic Adrenalectomy for Tumor Less Than 4 cm

Prospective Randomized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Unilateral Adrenal Tumors Less Than 4 cm in Diameter Among Patients With Primary Aldosteronism

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigator conduct a randomized clinical trial for the needlescopic and conventional laparoscopic adrenalectomy to assess whether mini laparoscopic adrenalectomy is better than conventional laparoscopic adrenalectomy in terms of pain, complication rate , and wound cosmetics

Detailed description

If the participant with unilateral PA tumor less than 4cm is willing to enter the clinical trial, he/she will be randomly assigned to two groups (conventional vs needlescopic laparoscopic adrenalectomy) in a 1:1 ratio, followed by preoperative assessement. All procedures were performed by experienced laparoscopic urologists (number of complex laparoscopic procedures \> 50 cases/yr for 10 yrs). The participant were blinded to the type of surgical procedure underwent until the pain assessment was completed in the morning of the second days after surgery

Conditions

• Post Operative Pain, Acute

Interventions

Type	Name	Description
DEVICE	Needlescopic laparoscopic adrenalectomy	Compared with traditional laparoscopic surgery using 5-12 mm instruments, the wound of needlescopic laparoscopic surgery is smaller. Postoperative pain and recovery are also better than traditional laparoscopic surgery.
DEVICE	conventional laparoscopic adrenalectomy	conventional laparoscopic adrenalectomy

Timeline

• Start date: 2023-02-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-01-09
• Last updated: 2023-01-09

Locations

1 site across 1 country: Taiwan