Adrenal DiseasePRANCT01676025
Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy
A study testing PRA and LA in people with Adrenal Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare two surgical methods of adrenalectomy. One is called PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at patient's back. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Adrenal Disease
- What is being tested?
- PRA and LA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to 28 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are expected to have benign adrenal disease at preoperative exams
- Patients who have pheochromocytoma measured less than 5cm, and the other benign adrenal tumors less than 7cm in diameter in preoperative CT scan
- Patients who do not have previous surgery history at the interested quadrant
- Patients who is I or II grade in ASA classification(American society of anesthesiologists' physical status classification)
- Patients who has tolerable liver function and renal function(bilirubin<2.0mg/dl and AST, ALT, serum creatinine within twice of upper normal range, coagulation panel : within normal limit)
- Patients whose BMI(body mass index) is less than 35
- Patients who are supposed to have normal cognitive function
- Patients who signed the consent paper.
Who cannot join
- Patients who are expected to have malignant or metastatic adrenal tumor at preoperative exams
- Patients who have bilateral adrenal tumors
- Patients who have condition to undergo the other operation at the abdomen together with adrenalectomy
- Pregnant patients
- Patients who have active or uncontrolled infection
- Patients who have medical problems as below
Show all 10Show fewer
- Uncontrollable hypertension with medication(Systolic BP>150 or diastolic BP>100)
- Angina, congestive heart failure, acute myocardial infection
- History of coronary angioplasty or Coronary artery bypass graft surgery
- History of stroke, transient ischemic attack with sequela
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Between PRA(Posterior Retroperitoneoscopic Adrenalectomy) and LA(Laparoscopic Adrenalectomy)
The purpose of this study is to compare two surgical methods of adrenalectomy. One is called PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through patient's abdominal cavity after making 3 or 4 holes in the abdomen.
Read the detailed description
Since 1992, transabdominal LA(laparoscopic adrenalectomy) has been a standard method of adrenalectomy. This traditional method has been used widely because this procedure provides wide view of the whole abdomen which is familiar to surgeons. But due to its unique location at retroperitoneum, adrenal is still not easy to approach. So various retroperitoneal approaches were designed and adjusted. Among those, PRA(posterior retroperitoneal adrenalectomy) has showed good outcomes in many institutes. PRA facilitates direct approach to kidney and adrenal gland, and so operative time can be shortened. But there has been no randomized controlled trial between these two methods.
Therefore, as experienced surgeons in both methods, we want to practice this study.
- Conditions
- Adrenal Disease
- Being tested
- PRA, LA
- Keywords
- pheochromocytoma, aldosteronism, cushing's syndrome, adrenal incidentaloma, Conn's syndrome
- Medical subject headings
- Adrenal Gland Diseases, Pheochromocytoma, Hyperaldosteronism, Cushing Syndrome, Adrenal incidentaloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRAProcedure or surgery
LAProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PRA | Experimental | Persons who get PRA surgery. Receives: Procedure: PRA |
| LA | Experimental | Persons who get LA surgery. Receives: Procedure: LA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
operation time will be measured by attending nerse
Measured: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Secondary outcomes (5)
Pain sensation after surgery
Pain score will be described daily during hospitalization, and also at out patient clinic after discharge
Measured: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Recovery of bowel movement
Gas out is regarded as a recovery of bowel movement
Measured: Participants will be followed the duration of hospital stay, an expected average of 5 days
Wound complication
Measured: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Blood loss during operation
Measured: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Intra-operative hemodynamic status
Events as below will be recorded and compared severe hypertension(systolic BP>200mmHg), severe hypotension(systolic BP<90mmHg), Tachycardia(HR>110/min), Bradycardia(HR<50/min)
Measured: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startSep 2012
- Primary completion28 Feb 2016
- Study completion28 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu Eun Lee, Seoul National University Hospital
- Investigators
- Kyueun Lee, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676025
- Sponsor's protocol ID
- Kyu.eun.lee-001
- Acronym
- PRA
- Status last verified
- Oct 2017
- First submitted
- 22 Aug 2012
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chai YJ, Yu HW, Song RY, Kim SJ, Choi JY, Lee KE. Lateral Transperitoneal Adrenalectomy Versus Posterior Retroperitoneoscopic Adrenalectomy for Benign Adrenal Gland Disease: Randomized Controlled Trial at a Single Tertiary Medical Center. Ann Surg. 2019 May;269(5):842-848. doi: 10.1097/SLA.0000000000002603.
PubMed 29189215
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Between PRA(Posterior Retroperitoneoscopic Adrenalectomy) and LA(Laparoscopic Adrenalectomy)
- ClinicalTrials.gov ID
- NCT01676025
- Acronym / sponsor ID
- PRA / Kyu.eun.lee-001
- Conditions
- Adrenal Disease
- Keywords
- pheochromocytoma, aldosteronism, cushing's syndrome, adrenal incidentaloma, Conn's syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 28 Feb 2016 (actual)
- First posted
- 30 Aug 2012 (estimated)
- 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 purpose of this study is to compare two surgical methods of adrenalectomy. One is called PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through patient's abdominal cavity after making 3 or 4 holes in the abdomen.
Detailed description
Since 1992, transabdominal LA(laparoscopic adrenalectomy) has been a standard method of adrenalectomy. This traditional method has been used widely because this procedure provides wide view of the whole abdomen which is familiar to surgeons. But due to its unique location at retroperitoneum, adrenal is still not easy to approach. So various retroperitoneal approaches were designed and adjusted. Among those, PRA(posterior retroperitoneal adrenalectomy) has showed good outcomes in many institutes. PRA facilitates direct approach to kidney and adrenal gland, and so operative time can be shortened. But there has been no randomized controlled trial between these two methods.
Therefore, as experienced surgeons in both methods, we want to practice this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRA | Experimental | Procedure: PRAPersons who get PRA surgery. |
| LA | Experimental | Procedure: LAPersons who get LA surgery. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who are expected to have benign adrenal disease at preoperative exams
- Patients who have pheochromocytoma measured less than 5cm, and the other benign adrenal tumors less than 7cm in diameter in preoperative CT scan
- Patients who do not have previous surgery history at the interested quadrant
- Patients who is I or II grade in ASA classification(American society of anesthesiologists' physical status classification)
- Patients who has tolerable liver function and renal function(bilirubin<2.0mg/dl and AST, ALT, serum creatinine within twice of upper normal range, coagulation panel : within normal limit)
Key exclusion criteria (10 listed)
- Patients who are expected to have malignant or metastatic adrenal tumor at preoperative exams
- Patients who have bilateral adrenal tumors
- Patients who have condition to undergo the other operation at the abdomen together with adrenalectomy
- Pregnant patients
- Patients who have active or uncontrolled infection
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 |
|---|---|---|
| PRA | Procedure or surgery | PRA |
| LA | Procedure or surgery | LA |
Primary outcome
Operation time
Time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
operation time will be measured by attending nerse
5 secondary outcomes
Pain sensation after surgery
Time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Recovery of bowel movement
Time frame: Participants will be followed the duration of hospital stay, an expected average of 5 days
Wound complication
Time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Blood loss during operation
Time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Intra-operative hemodynamic status
Time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Derived from this study: PubMed 29189215Chai YJ, Yu HW, Song RY, Kim SJ, Choi JY, Lee KE. Lateral Transperitoneal Adrenalectomy Versus Posterior Retroperitoneoscopic Adrenalectomy for Benign Adrenal Gland Disease: Randomized Controlled Trial at a Single Tertiary Medical Center. Ann Surg. 2019 May;269(5):842-848. doi: 10.1097/SLA.0000000000002603.
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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. This study is not recruiting at the moment.
Kyueun Lee, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRA and LA in people with Adrenal Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 6 Oct 2017. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks). 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 NCT01676025, which also lists 1 linked publication.
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 6 Oct 2017.