Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy (PRA)

Seoul National University

Status

Completed

Conditions

Adrenal Disease

Treatments

Procedure: PRA

Procedure: LA

Study type

Interventional

Funder types

Other

Identifiers

NCT01676025

Kyu.eun.lee-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

83 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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