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

NCT05675124 | Not Yet Recruiting

• 1 other identifier: 202204074RINC
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain, Acute

Keywords

Visual Analogue Scale; Post Operative Pain; Dosage of analgesic; Cosmetic

Outcome Measures

Primary Outcomes (1)

• Timing that two consecutive VAS less than 3 points

  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)

  up to 1 month postoperatively

Secondary Outcomes (1)

• Cumulative morphine dosing

  Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change)

Study Arms (2)

Needlescopic laparoscopic adrenalectomy

EXPERIMENTAL

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

Device: Needlescopic laparoscopic adrenalectomy

conventional laparoscopic adrenalectomy

ACTIVE COMPARATOR

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.

Device: conventional laparoscopic adrenalectomy

Interventions

Needlescopic laparoscopic adrenalectomy 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.

Needlescopic laparoscopic adrenalectomy

conventional laparoscopic adrenalectomy DEVICE

conventional laparoscopic adrenalectomy

conventional laparoscopic adrenalectomy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 20 years old.
• Primary aldosteronism with unilateral adrenal lesions smaller than 4 cm
• Indications for laparoscopic surgery.
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jeff Chueh

  Dep. of Urology, NTUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Chueh, Director, Dep. of Urology, NTUH

CONTACT

(02)2312-3456; chuehs@ntuh.gov.tw

Chu-wen Fang

CONTACT

007abao@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: January 9, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)