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Clinical Trials in Taiwan / NCT05675124
Starting soon Not applicable

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

NCT05675124 · tracked via the Priya Life Science Taiwan tracker
Sponsor
National Taiwan University Hospital
Phase
Not applicable
Started
2023-02-01
Last updated
2023-01-09

Condition(s) studied

Post Operative Pain, Acute

Investigational drug(s) / intervention(s)

Needlescopic laparoscopic adrenalectomyconventional laparoscopic adrenalectomy

Needlescopic laparoscopic adrenalectomy: 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: conventional laparoscopic adrenalectomy

Study 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

Eligibility

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
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 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

Primary outcome measure(s)

  • 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)

Trial sites (1)

FacilityCityRegionStatus
National Taiwan University Hospital Taipei Taiwan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05675124 on ClinicalTrials.gov ↗ ← All trials in Taiwan