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Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy (PRA)

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Kyu Eun Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01676025
First received: August 22, 2012
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Adrenal Disease
 Procedure: PRA
Procedure: LA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Between PRA(Posterior Retroperitoneoscopic Adrenalectomy) and LA(Laparoscopic Adrenalectomy)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Operation time [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    operation time will be measured by attending nerse


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Pain score will be described daily during hospitalization, and also at out patient clinic after discharge

  • Recovery of bowel movement [ Time Frame: Participants will be followed the duration of hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]
    Gas out is regarded as a recovery of bowel movement

  • Wound complication [ Time Frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 84
Study Start Date: September 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRA
Persons who get PRA surgery.
 Procedure: PRA
Experimental: LA
Persons who get LA surgery.
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676025

Contacts
Contact: Kyueun Lee, Ph.D 82-2-2072-2081 kyu.eun.lee.md@gmail.com
Contact: Youngjun Chai, Bachelor 82-10-3394-3000 kevinjoon@naver.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyueun Lee, Ph.D         kyu.eun.lee.md@gmail.com    
Principal Investigator: Kyueun Lee, Ph.D            
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Kyueun Lee, Ph.D Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Kyu Eun Lee, Assistant Professor, Department of Surgery, Seoul National University College of Medicine, Seoul, Korea, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01676025     History of Changes
Other Study ID Numbers: Kyu.eun.lee-001
Study First Received: August 22, 2012
Last Updated: April 11, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
pheochromocytoma
aldosteronism
cushing's syndrome
adrenal incidentaloma
Conn's syndrome

Additional relevant MeSH terms:
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013