About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over the age of 20 years old.
Primary aldosteronism with unilateral adrenal lesions smaller than 4 cm
Indications for laparoscopic surgery.
Informed consent
Disqualifiers
Over 80 years old
Suspected adrenal malignancy or pheochromocytoma
Other concurrent surgery
Patients who underwent bilateral adrenal tumor resection at the same time
Trial design
Parallel
Treatments tested in this trial
Needlescopic laparoscopic adrenalectomy
DeviceCompared 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 adrenalectomy
Deviceconventional laparoscopic adrenalectomy
Treatment groups
Trial 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)
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)
Sponsors and contacts
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