Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy (PRA)

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.

Study Overview

• Status: Completed
• Conditions: Adrenal Disease
• Intervention / Treatment: Procedure: PRA; Procedure: LA

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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRA; Persons who get PRA surgery.	Procedure: PRA
Experimental: LA; Persons who get LA surgery.	Procedure: LA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	operation time will be measured by attending nerse	Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain sensation after surgery	Pain score will be described daily during hospitalization, and also at out patient clinic after discharge	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	Participants will be followed the duration of hospital stay, an expected average of 5 days
Wound complication		Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Blood loss during operation		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)	Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Kyueun Lee, Ph.D, Seoul National University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 28, 2016
• Study Completion (Actual): February 28, 2016

Study Registration Dates

• First Submitted: August 22, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 30, 2012

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: pheochromocytoma; adrenal incidentaloma; aldosteronism; cushing's syndrome; Conn's syndrome
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases
• Other Study ID Numbers: Kyu.eun.lee-001