Clinical Trial: Efficacy and Safety of Posterior Retroperitoneoscopic Adrenalectomy: A Comparative Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Posterior Retroperitoneoscopic Approach Versus Transperitoneal Laparoscopic Approach in Management of Adrenal Tumors: A Randomized Comparative Study

Brief Summary: This randomized comparative study assesses the safety and efficacy of the posterior retroperitoneoscopic adrenalectomy in comparison to the standard, anterior transperitoneal approach and suppose that this new technique is a safe and effective alternative to the standard approach.

Detailed Summary:

Aim of the study:

To upgrade the urosurgical care level for candidate of surgical adrenalectomy due to adrenal diseases, to increase efficacy of the procedure and shorten the operative time and duration of hospital stay and convalescence.

Study Objective:

Comparing the safety and efficacy of posterior retroperitoneoscopic versus anterior transperitoneal adrenalectomy, as regard to the operative time, estimated intraoperative blood loss, days of postoperative hospital stay, and rate of complications.

Study Question:

Can the posterior retroperitoneoscopic approach provide a better alternative to anterior laparoscopic approach in terms of effectiveness and safety for laparoscopic adrenalectomy?

Study Hypothesis:

Investigators suggest that posterior retroperitoneoscopic approach is a safe and effective alternative to anterior transperitoneal approach for adrenalectomy with less operative time, estimated blood loss, postoperative days of hospitalization and rate of complications.

Significance and Relevance:

This study is suspected to be beneficial for urologists and oncology surgeons, as they can select the most effective intervention for patients with adrenal disease.

Study setting:

The study will be carried out over one year starting from 4/2015 to 5/2016, including the operations and data management. Operative procedures will be carried out at Urology Departments on Suez Canal, and A
Sponsor: Suez Canal University

Current Primary Outcome:

• Mean operative time [ Time Frame: 1 year ]
  total time from the first abdominal incision to the last suture, and the time elapsed to identify the adrenal vein, a critical step at the operation.
• Mean amount of intraoperative blood loss [ Time Frame: 1 year ]
  measured in milliliters.
• Mean days of postoperative hospital stay [ Time Frame: 1 year ]
  include the number of days to full diet, to mobilization and to complete recovery; i.e. return to usual daily activity.
• Rate of complications [ Time Frame: 1.5 year ]
  classified by Clavien-Dindo classification system

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Mean of postoperative pain score [ Time Frame: 1 year ]
  using visual analogue scale or face scale score (according to participant's level of education)
• mean of scar cosmetic assessment score [ Time Frame: 1.1 year ]
  The patient satisfaction of the scar will be assessed by THE SUM of scores of three questionnaires; body image questionnaire score + photo series questionnaire score + future surgical procedure preference questionnaire score

Original Secondary Outcome: Same as current

Information By: Suez Canal University

Dates:
Date Received: November 15, 2015
Date Started: April 2015
Date Completion:
Last Updated: March 1, 2017
Last Verified: March 2017