search
Back to results

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

Primary Purpose

Post Operative Pain, Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Needlescopic laparoscopic adrenalectomy
conventional laparoscopic adrenalectomy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Operative Pain, Acute focused on measuring Visual Analogue Scale, Post Operative Pain, Dosage of analgesic, Cosmetic

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Needlescopic laparoscopic adrenalectomy

conventional laparoscopic adrenalectomy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Cumulative morphine dosing
>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)

Full Information

First Posted
August 19, 2022
Last Updated
January 5, 2023
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05675124
Brief Title
Comparison of Needlescopic vs. Conventional Laparoscopic Adrenalectomy for Tumor Less Than 4 cm
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Acute
Keywords
Visual Analogue Scale, Post Operative Pain, Dosage of analgesic, Cosmetic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Needlescopic laparoscopic adrenalectomy
Arm Type
Experimental
Arm Description
Needlescopic laparoscopic surgery refers to the use of instruments with a diameter of less than or equal to 3 mm for laparoscopic surgery.
Arm Title
conventional laparoscopic adrenalectomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Needlescopic laparoscopic adrenalectomy
Intervention 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.
Intervention Type
Device
Intervention Name(s)
conventional laparoscopic adrenalectomy
Intervention Description
conventional laparoscopic adrenalectomy
Primary Outcome Measure Information:
Title
Timing that two consecutive VAS less than 3 points
Description
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)
Time Frame
up to 1 month postoperatively
Secondary Outcome Measure Information:
Title
Cumulative morphine dosing
Description
>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)
Time Frame
Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Chueh, Director, Dep. of Urology, NTUH
Phone
(02)2312-3456
Ext
263155。
Email
chuehs@ntuh.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chu-wen Fang
Email
007abao@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Chueh
Organizational Affiliation
Dep. of Urology, NTUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18164803
Citation
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.
Results Reference
background
PubMed Identifier
11743271
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs