Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy

Not Applicable

Completed

• Conditions: Adrenal Disease
• Interventions: Procedure: LA; Procedure: PRA

• Registration Number: NCT01676025
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-30
• Study Start: 2012-09
• Primary Completion: 2016-02-28
• Study Completion: 2016-02-28
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LA	LA	Persons who get LA surgery.
PRA	PRA	Persons who get PRA surgery.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain sensation after surgery	Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks	Pain score will be described daily during hospitalization, and also at out patient clinic after discharge
Recovery of bowel movement	Participants will be followed the duration of hospital stay, an expected average of 5 days	Gas out is regarded as a recovery of bowel movement
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	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)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of