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Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy (PRA)

Primary Purpose

Adrenal Disease

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

PRA

About this trial

This is an interventional treatment trial for Adrenal Disease focused on measuring pheochromocytoma, aldosteronism, cushing's syndrome, adrenal incidentaloma, Conn's syndrome

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PRA

Arm Description

Persons who get PRA surgery.

Persons who get LA surgery.

Outcomes

Primary Outcome Measures

Operation time

operation time will be measured by attending nerse

Secondary Outcome Measures

Pain sensation after surgery

Pain score will be described daily during hospitalization, and also at out patient clinic after discharge

Recovery of bowel movement

Gas out is regarded as a recovery of bowel movement

Wound complication

Blood loss during operation

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)

Full Information

NCT ID

NCT01676025

First Posted

August 22, 2012

Last Updated

October 4, 2017

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01676025

Brief Title

Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy

Acronym

PRA

Official Title

Randomized Controlled Trial Between PRA(Posterior Retroperitoneoscopic Adrenalectomy) and LA(Laparoscopic Adrenalectomy)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

February 28, 2016 (Actual)

Study Completion Date

February 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adrenal Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRA

Arm Type

Experimental

Arm Description

Persons who get PRA surgery.

Arm Title

Arm Type

Experimental

Arm Description

Persons who get LA surgery.

Intervention Type

Procedure

Intervention Name(s)

PRA

Intervention Type

Procedure

Intervention Name(s)

Primary Outcome Measure Information:

Title

Operation time

Description

operation time will be measured by attending nerse

Time Frame

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

Secondary Outcome Measure Information:

Title

Pain sensation after surgery

Description

Pain score will be described daily during hospitalization, and also at out patient clinic after discharge

Time Frame

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

Title

Recovery of bowel movement

Description

Gas out is regarded as a recovery of bowel movement

Time Frame

Participants will be followed the duration of hospital stay, an expected average of 5 days

Title

Wound complication

Time Frame

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

Title

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

Title

Intra-operative hemodynamic status

Description

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)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyueun Lee, Ph.D

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

29189215

Citation

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.

Results Reference

derived

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Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy

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