Posterior Retroperitoneoscopic Approach Versus Transperitoneal Laparoscopic Approach in Management of Adrenal Tumors: A Randomized Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Suez Canal University
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Mean operative time
Study Overview
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 Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients have one or more of the following;
- •Functioning adrenal adenoma,
- •Nonfunctioning adenoma < 7 cm by pelvi-abdominal CT,
- •Secondary metastatic adrenal mass suitable for laparoscopic adrenalectomy,
- •Adrenal hyperplasia indicated for laparoscopic adrenalectomy.
Exclusion Criteria
- •Patients with cardiovascular disease (as angina, acute myocardial infection, congestive heart failure); history of stroke, transient myocardial attacks, coronary angioplasty or coronary artery bypass graft surgery, or any other contraindication for laparoscopy e.g. COPD,
- •Pregnant females,
- •Locally advanced malignant disease,
- •Evidence of regional lymph node involvement,
- •Vascular malignant invasion,
- •Malignant uncontrolled hypertension with pheochromocytoma,
- •Need for other simultaneous surgical intervention at the same session e.g. cholecystectomy.
Arms & Interventions
Group 1
patient had posterior retroperitoneoscopic adrenalectomy
Intervention: Posterior retroperitoneoscopic adrenalectomy (Procedure)
Group 2
patient had Transperitoneal laparoscopic adrenalectomy
Intervention: Transperitoneal laparoscopic adrenalectomy (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- mean of scar cosmetic assessment score(1.1 year)
- Mean of postoperative pain score(1 year)
Investigators
Ahmed Mohamed Bakr Arabi
Demonstrator
Suez Canal University