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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Post Operative Pain, Acute

Intervention / Treatment
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* Device: Needlescopic laparoscopic adrenalectomy
* Device: conventional laparoscopic adrenalectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 20 years old. Primary aldosteronism with unilateral adrenal lesions smaller than 4 cm Indications for laparoscopic surgery. Informed consent Exclusion Criteria: Over 80 years old Suspected adrenal malignancy or pheochromocytoma Other concurrent surgery Patients who underwent bilateral adrenal tumor resection at the same time History of peritonitis or having undergoing major ipsilateral abdominal surgery. 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.) Opioid addiction Patient have side effects from taking of acetaminophen, celecoxib or opioids Acute intoxication of alcohol, sleep aids, anesthetics, centrally acting analgesics, opium or psychotropic drugs has occurred. Patients using monoamine oxidase inhibitors (MAOIs) concurrently or within the past 14 days. Patients with chronic pain or respiratory depression (such as chronic obstructive pulmonary disease) Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Needlescopic laparoscopic adrenalectomy<br>Needlescopic laparoscopic surgery refers to the use of instruments with a diameter of less than or equal to 3 mm for laparoscopic surgery. | Device: Needlescopic laparoscopic adrenalectomy<br>* 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.<br>|
| Active Comparator: conventional laparoscopic adrenalectomy<br>a 12 mm camera port ,and two additional (left anterior axillary line and left midclavicular line; for left tumors) or three additional(right anterior axillary line, right midclavicular line, and subxiphoid; for right tumors) 5 mm working ports along the ipsilateral subcostal were created regionally. | Device: conventional laparoscopic adrenalectomy<br>* conventional laparoscopic adrenalectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | up to 1 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual Analogue Scale, Post Operative Pain, Dosage of analgesic, Cosmetic