Pheochromocytoma Clinical Trial
— PostLapAdrnlOfficial title:
Posterior Retroperitoneoscopic Approach Versus Transperitoneal Laparoscopic Approach in Management of Adrenal Tumors: A Randomized Comparative Study
Verified date | March 2017 |
Source | Suez Canal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | December 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria Main University Hospital | Alexandria | |
Egypt | Suez Canal University Hospital | Ismailia |
Lead Sponsor | Collaborator |
---|---|
Suez Canal University | Alexandria University |
Egypt,
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Dickson PV, Alex GC, Grubbs EG, Ayala-Ramirez M, Jimenez C, Evans DB, Lee JE, Perrier ND. Posterior retroperitoneoscopic adrenalectomy is a safe and effective alternative to transabdominal laparoscopic adrenalectomy for pheochromocytoma. Surgery. 2011 Sep;150(3):452-8. doi: 10.1016/j.surg.2011.07.004. — View Citation
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean operative time | 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. | 1 year | |
Primary | Mean amount of intraoperative blood loss | measured in milliliters. | 1 year | |
Primary | Mean days of postoperative hospital stay | include the number of days to full diet, to mobilization and to complete recovery; i.e. return to usual daily activity. | 1 year | |
Primary | Rate of complications | classified by Clavien-Dindo classification system | 1.5 year | |
Secondary | Mean of postoperative pain score | using visual analogue scale or face scale score (according to participant's level of education) | 1 year | |
Secondary | mean of scar cosmetic assessment score | 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 | 1.1 year |
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