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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
