Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy

Adrenal Disease Clinical Trial

— PRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676025
• Other study ID #: Kyu.eun.lee-001
• Status: Completed
• Phase: N/A
• First received: August 22, 2012
• Last updated: October 4, 2017
• Start date: September 2012
• Est. completion date: February 28, 2016

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 28, 2016
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Disease
• Adrenal Gland Diseases

Intervention

Procedure:
• PRA

• LA

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Wound complication		Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Secondary	Blood loss during operation		Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
Secondary	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