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

N/ANot Yet RecruitingNCT05675124

National Taiwan University Hospital130 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

130

Conditions

Post Operative Pain, Acute

Interventions

Needlescopic laparoscopic adrenalectomyDEVICE

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.

conventional laparoscopic adrenalectomyDEVICE

conventional laparoscopic adrenalectomy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Over the age of 20 years old. 2. Primary aldosteronism with unilateral adrenal lesions smaller than 4 cm 3. Indications for laparoscopic surgery. 4. Informed consent Exclusion Criteria: 1. Over 80 years old 2. Suspected adrenal malignancy or pheochromocytoma 3. Other concurrent surgery 4. Patients who underwent bilateral adrenal tumor resection at the same time 5. History of peritonitis or having undergoing major ipsilateral abdominal surgery. 6. American Society of Anesthesiologists (ASA) Class III or IV (with severe cardiovascular disease, uncontrolled hypertension, diabetes, chronic pulmonary obstructive pulmonary disease, morbid obesity (BMI \> 40), dialysis patients, myocardial infarction, stroke, coronary artery disease, liver or coagulation dysfunction, etc.) 7. Opioid addiction 8. Patient have side effects from taking of acetaminophen, celecoxib or opioids 9. Acute intoxication of alcohol, sleep aids, anesthetics, centrally acting analgesics, opium or psychotropic drugs has occurred. 10. Patients using monoamine oxidase inhibitors (MAOIs) concurrently or within the past 14 days. 11. Patients with chronic pain or respiratory depression (such as chronic obstructive pulmonary disease) 12. Pregnancy

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Timing that two consecutive VAS less than 3 points

Timing that two consecutive VAS less than 3 points after operation * The nurse for pain assessement would not know the allocation of the patient to this trial arms * Wound pain was assessed on a visual analogue scale (VAS) from 0 (none) to 10 (worst)

Time frame: up to 1 month postoperatively

Secondary Outcomes

Cumulative morphine dosing

\>On the operative day: morphine (10mg/1mL/amp) 2mg IV Q4H PRN(every 4 hours.Pro re nata) was administered intravenously. \> Post-op Day 1: acetaminophen (500mg/tab) # 1 PO QID (quater in die) and celecoxib (200 mg/Cap) # 1 PO QD( quaque die), morphine (10mg/1mL/amp) 2mg IV Q4H PRN (every 4 hours.Pro re nata) as rescue analgesia (as VAS \>=3)

Time frame: Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change)

Central Contacts

Jeff Chueh, Director, Dep. of Urology, NTUH

CONTACT

(02)2312-3456 chuehs@ntuh.gov.tw

Chu-wen Fang

CONTACT

007abao@gmail.com

Data from ClinicalTrials.gov

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