Clinical trial NCT05675124: Comparison of Needlescopic vs. Conventional Laparoscopic Adrenalectomy for Tumor Less Than 4 cm
Official title: Prospective Randomized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Unilateral Adrenal Tumors Less Than 4 cm in Diameter Among Patients With Primary Aldosteronism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Pain, Acute
Keywords: Visual Analogue Scale
Post Operative Pain
Dosage of analgesic
Cosmetic
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Timing that two consecutive VAS less than 3 points
timeFrame: up to 1 month postoperatively
Secondary outcomes:
measure: Cumulative morphine dosing
timeFrame: Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Dep. of Urology, NTUH
name: Jeff Chueh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liao CH, Lai MK, Li HY, Chen SC, Chueh SC. Laparoscopic adrenalectomy using needlescopic instruments for adrenal tumors less than 5cm in 112 cases. Eur Urol. 2008 Sep;54(3):640-6. doi: 10.1016/j.eururo.2007.12.028. Epub 2007 Dec 26.
citation: Chueh SC, Chen J, Chen SC, Liao CH, Lai MK. Clipless laparoscopic adrenalectomy with needlescopic instruments. J Urol. 2002 Jan;167(1):39-42; discussion 42-3. doi: 10.1016/s0022-5347(05)65378-5.