Clinical Trial: Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Seoul National University Hospital

Current Primary Outcome: Operation time [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    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 ]
    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 ]
  • 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 ]
  • 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 ]
    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)


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: August 22, 2012
Date Started: September 2012
Date Completion: August 2017
Last Updated: September 16, 2016
Last Verified: September 2016