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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorNational Taiwan University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Needlescopic laparoscopic adrenalectomy

    Device

    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 adrenalectomy

    Device

    conventional laparoscopic adrenalectomy

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Needlescopic laparoscopic adrenalectomyExperimental treatment 1 intervention
Group B: conventional laparoscopic adrenalectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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)

Other outcomes

Sponsors and contacts

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