Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy

NCT01676025 | Completed

• 1 other identifier: Kyu.eun.lee-001
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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. The other is LA(laparoscopic adrenalectomy) which is performed through patient's abdominal cavity after making 3 or 4 holes in the abdomen.

Conditions

Adrenal Disease

Keywords

pheochromocytoma; aldosteronism; cushing's syndrome; adrenal incidentaloma; Conn's syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain sensation after surgery

  Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks

• 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

  Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks

Study Arms (2)

PRA

EXPERIMENTAL

Persons who get PRA surgery.

Procedure: PRA

LA

EXPERIMENTAL

Persons who get LA surgery.

Procedure: LA

Interventions

PRA PROCEDURE

PRA

LA PROCEDURE

LA

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29189215 DERIVED

MeSH Terms

Conditions

Adrenal Gland Diseases; Pheochromocytoma; Hyperaldosteronism; Cushing Syndrome; Adrenal incidentaloma

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adrenocortical Hyperfunction

Study Officials

• Kyueun Lee, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Surgery, Seoul National University College of Medicine, Seoul, Korea

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 30, 2012
• Study Start: September 1, 2012
• Primary Completion: February 28, 2016
• Study Completion: February 28, 2016
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

KR (1)