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

NCT ID: NCT05675124

Condition: Post Operative Pain, Acute

Conditions: Official terms:
Pain, Postoperative

Conditions: Keywords:
Visual Analogue Scale
Post Operative Pain
Dosage of analgesic
Cosmetic

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Needlescopic laparoscopic adrenalectomy
Description: 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.
Arm group label: Needlescopic laparoscopic adrenalectomy

Intervention type: Device
Intervention name: conventional laparoscopic adrenalectomy
Description: conventional laparoscopic adrenalectomy
Arm group label: conventional laparoscopic adrenalectomy

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

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Country: Taiwan

Start date: February 1, 2023

Completion date: December 1, 2026

Lead sponsor:
Agency: National Taiwan University Hospital
Agency class: Other

Source: National Taiwan University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05675124

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