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

Not Applicable

Not yet recruiting

• Conditions: Post Operative Pain, Acute
• Interventions: Device: conventional laparoscopic adrenalectomy; Device: Needlescopic laparoscopic adrenalectomy

• Registration Number: NCT05675124
• Lead Sponsor: National Taiwan University Hospital

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-08-19
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-05
• Study First Posted: 2023-01-09
• Last Update Posted: 2023-01-09
• Study Start: 2023-02-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional laparoscopic adrenalectomy	conventional laparoscopic adrenalectomy	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.
Needlescopic laparoscopic adrenalectomy	Needlescopic laparoscopic adrenalectomy	Needlescopic laparoscopic surgery refers to the use of instruments with a diameter of less than or equal to 3 mm for laparoscopic surgery.

Primary Outcome Measures

Name	Time	Method
Timing that two consecutive VAS less than 3 points	up to 1 month postoperatively	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)

Secondary Outcome Measures

Name	Time	Method
Cumulative morphine dosing	Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change)	\>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)

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan