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NCT Number: NCT05675124

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

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

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Timing that two consecutive VAS less than 3 points

    Time frame: 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 outcomes

  1. Cumulative morphine dosing

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Chu-wen Fang

CONTACT

[email protected]

Jeff Chueh, Director, Dep. of Urology, NTUH

CONTACT

[email protected]

(02)2312-3456 ext. 263155。

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2023
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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