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Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy

NCT ID: NCT01676025

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-02-28

Brief Summary

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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

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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

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Adrenal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PRA

Persons who get PRA surgery.

Group Type EXPERIMENTAL

PRA

Intervention Type PROCEDURE

LA

Persons who get LA surgery.

Group Type EXPERIMENTAL

LA

Intervention Type PROCEDURE

Interventions

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PRA

Intervention Type PROCEDURE

LA

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyu Eun Lee

Assistant Professor, Department of Surgery, Seoul National University College of Medicine, Seoul, Korea

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyueun Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 29189215 (View on PubMed)

Other Identifiers

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Kyu.eun.lee-001

Identifier Type: -

Identifier Source: org_study_id