Comparison of Needlescopic vs. Conventional Laparoscopic Adrenalectomy for Tumor Less Than 4 cm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Needlescopic laparoscopic adrenalectomy, conventional laparoscopic adrenalectomy.
- Who it may be relevant to
- Registry conditions: Post Operative Pain, Acute. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
Interventions
- Device 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. - Device conventional laparoscopic adrenalectomy
conventional laparoscopic adrenalectomy
Primary outcome measures
- Timing that two consecutive VAS less than 3 points [Time frame: up to 1 month postoperatively]
Secondary outcome measures (1)
- Cumulative morphine dosing [Time frame: Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Publications
- Liao CH, Lai MK, Li HY, Chen SC, Chueh SC. Laparoscopic adrenalectomy using needlescopic instruments for adrenal tumors less than 5cm in 112 cases. Eur Urol. 2008 Sep;54(3):640-6. doi: 10.1016/j.eururo.2007.12.028. Epub 2007 Dec 26. PMID 18164803
- Chueh SC, Chen J, Chen SC, Liao CH, Lai MK. Clipless laparoscopic adrenalectomy with needlescopic instruments. J Urol. 2002 Jan;167(1):39-42; discussion 42-3. doi: 10.1016/s0022-5347(05)65378-5. PMID 11743271
Identifiers
NCT: NCT05675124 · 202204074RINC