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

NCT ID: NCT05675124

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-12-01

Brief 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

Conditions

Post Operative Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Needlescopic laparoscopic adrenalectomy

Needlescopic laparoscopic surgery refers to the use of instruments with a diameter of less than or equal to 3 mm for laparoscopic surgery.

Group Type: EXPERIMENTAL

Needlescopic laparoscopic adrenalectomy

Intervention Type: 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

a 12 mm camera port ,and two additional (left anterior axillary line and left midclavicular line; for left tumors) or three additional(right anterior axillary line, right midclavicular line, and subxiphoid; for right tumors) 5 mm working ports along the ipsilateral subcostal were created regionally.

Group Type: ACTIVE_COMPARATOR

conventional laparoscopic adrenalectomy

Intervention Type: DEVICE

conventional laparoscopic adrenalectomy

Interventions

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.

Intervention Type: DEVICE

conventional laparoscopic adrenalectomy

conventional laparoscopic adrenalectomy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Chueh

Role: PRINCIPAL_INVESTIGATOR

Dep. of Urology, NTUH

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Jeff Chueh, Director, Dep. of Urology, NTUH

Role: CONTACT

chuehs@ntuh.gov.tw

(02)2312-3456 ext. 263155。

Chu-wen Fang

Role: CONTACT

007abao@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 18164803 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11743271 (View on PubMed)

Other Identifiers

202204074RINC

Identifier Type: -

Identifier Source: org_study_id