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

January 5, 2023 updated by: National Taiwan University Hospital

Prospective Randomized Comparison of Needlescopic Versus Conventional Laparoscopic Adrenalectomy for Unilateral Adrenal Tumors Less Than 4 cm in Diameter Among Patients With Primary Aldosteronism

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jeff Chueh, Director, Dep. of Urology, NTUH
  • Phone Number: 263155。 (02)2312-3456
  • Email: chuehs@ntuh.gov.tw

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
Device: conventional laparoscopic adrenalectomy
conventional laparoscopic adrenalectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing that two consecutive VAS less than 3 points
Time Frame: up to 1 month postoperatively

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative morphine dosing
Time Frame: Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change)

>On the operative day: morphine (10mg/1mL/amp) 2mg IV Q4H PRN(every 4 hours.Pro re nata) was administered intravenously.

> Post-op Day 1: acetaminophen (500mg/tab) # 1 PO QID (quater in die) and celecoxib (200 mg/Cap) # 1 PO QD( quaque die), morphine (10mg/1mL/amp) 2mg IV Q4H PRN (every 4 hours.Pro re nata) as rescue analgesia (as VAS >=3)
Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Jeff Chueh, Dep. of Urology, NTUH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

June 1, 2026

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Estimate)

January 9, 2023

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202204074RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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