Post Operative Pain, AcuteNCT05675124
Comparison of Needlescopic vs. Conventional Laparoscopic Adrenalectomy for Tumor Less Than 4 cm
A study testing Needlescopic laparoscopic adrenalectomy and conventional laparoscopic adrenalectomy in people with Post Operative Pain, Acute, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Needlescopic laparoscopic adrenalectomy and conventional laparoscopic adrenalectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 20 years old.
- Primary aldosteronism with unilateral adrenal lesions smaller than 4 cm
- Indications for laparoscopic surgery.
- Informed consent
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chu-wen Fang contact
About this study
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
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
Read the 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
- Being tested
- Needlescopic laparoscopic adrenalectomy, conventional laparoscopic adrenalectomy
- Keywords
- Visual Analogue Scale, Post Operative Pain, Dosage of analgesic, Cosmetic
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needlescopic laparoscopic adrenalectomyDevice
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 adrenalectomyDevice
conventional laparoscopic adrenalectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: conventional laparoscopic adrenalectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 1 month postoperatively
Secondary outcomes (1)
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)
Measured: Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Chueh, Principal investigator, Dep. of Urology, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675124
- Sponsor's protocol ID
- 202204074RINC
- Status last verified
- Jan 2023
- First submitted
- 19 Aug 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 18164803Chueh 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.
PubMed 11743271
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05675124
- Acronym / sponsor ID
- 202204074RINC
- Conditions
- Post Operative Pain, Acute
- Keywords
- Visual Analogue Scale, Post Operative Pain, Dosage of analgesic, Cosmetic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needlescopic laparoscopic adrenalectomy | Experimental | Device: Needlescopic laparoscopic adrenalectomyNeedlescopic laparoscopic surgery refers to the use of instruments with a diameter of less than or equal to 3 mm for laparoscopic surgery. |
| conventional laparoscopic adrenalectomy | Active comparator | Device: conventional laparoscopic adrenalectomya 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over the age of 20 years old.
- Primary aldosteronism with unilateral adrenal lesions smaller than 4 cm
- Indications for laparoscopic surgery.
- Informed consent
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needlescopic laparoscopic adrenalectomyCompared 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 | Needlescopic laparoscopic adrenalectomy |
| conventional laparoscopic adrenalectomyconventional laparoscopic adrenalectomy | Device | conventional laparoscopic adrenalectomy |
Primary outcome
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)
1 secondary outcome
Cumulative morphine dosing
Time frame: Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Background: PubMed 18164803Liao 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.
- Background: PubMed 11743271Chueh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chu-wen Fang contact
Jeff Chueh principal investigator
Dep. of Urology, NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needlescopic laparoscopic adrenalectomy and conventional laparoscopic adrenalectomy in people with Post Operative Pain, Acute, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeff Chueh, Director, Dep. of Urology, NTUH ((02)2312-3456 ext. 263155。, chuehs@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing that two consecutive VAS less than 3 points (time frame: up to 1 month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05675124, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.