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Efficacy and Safety of Posterior Retroperitoneoscopic Adrenalectomy: A Comparative Study (PostLapAdrnl)

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ClinicalTrials.gov Identifier: NCT02618694
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Alexandria University
Information provided by (Responsible Party):
Ahmed Mohamed Bakr Arabi, Suez Canal University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adrenal Mass Adrenal Disease Pheochromocytoma Cushing Syndrome Procedure: Posterior retroperitoneoscopic adrenalectomy Procedure: Transperitoneal laparoscopic adrenalectomy Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Posterior Retroperitoneoscopic Approach Versus Transperitoneal Laparoscopic Approach in Management of Adrenal Tumors: A Randomized Comparative Study
Study Start Date : April 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
patient had posterior retroperitoneoscopic adrenalectomy
 Procedure: Posterior retroperitoneoscopic adrenalectomy
Patient is in prone, half Jack-knife position, and hips and knees are fixed in 75-90°. A 15 mm trocar incision just below the tip 12th rib. Prepare a small retroperitoneal space with finger and insert two 5 mm trocars about 5 cm lateral and medial to the first trocar with digital guidance. Medial trocar will be inserted upward. Lateral one will be lateral and below the 11th rib. Dissect inferior to diaphragm and retraction of the kidney downward. Mobilize the adrenal gland. At right side, start medial and caudally. Control the adrenl arteries crossing the IVC posteriorly. Prepare adrenal vein posterolaterally. Control between two clips. Continue gland dissection laterally and cranially. At left side, prepare the adrenal vein between the gland and diaphragm medial to the upper pole of the kidney. Dissect medial, lateral and cranially. Retrieve the mass through middle incision. Insert a drain and close skin incisions (Walz M. K., 2005).
Other Name: Posterior retroperitoneal laparoscopic adrenalectomy
Active Comparator: Group 2
patient had Transperitoneal laparoscopic adrenalectomy
 Procedure: Transperitoneal laparoscopic adrenalectomy
On right side, patient is on supine position. Put a trocar at umbilicus for the camera. Put 4 trocars 1-2 cm subcostal from subxiphoid (10-12 mm) for liver retractor, to far lateral (5 mm) and two 10 mm trocars inbetween. Retract liver, incise the retroperitoneum, and identify right adrenal gland between upper pole of the kidney and IVC. Dissect gland from the kidney than laterally and posteriorly from the diaphragm. Expose, apply clips to, and divide the adrenal vein. On left side, patient is on lateral decubitus. Put a trocar at umbilicus for the camera, 4 trocars 1-2 cm subcostal from the midline to the far most lateral possible (the last is 5 mm the rest are 10 mm). Mobilize colon flexure and expose the kidney. Separate kidney from the pancreas and spleen. Mobilize the tumor, starting by posterior surface, superior border then from the renal surface. Divide the adrenal vein. Retrieve the mass (Suzuki, Tsuru, & Ihara, 2012; Linos, 2005; George & Kavoussi, 2010).
Other Names:
  • Anterior laparoscopic adrenalectomy
  • Lateral laparoscopic adrenalectomy


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Mean amount of intraoperative blood loss [ Time Frame: 1 year ]
    measured in milliliters.

  3. 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.

  4. Rate of complications [ Time Frame: 1.5 year ]
    classified by Clavien-Dindo classification system


Secondary Outcome Measures :
  1. Mean of postoperative pain score [ Time Frame: 1 year ]
    using visual analogue scale or face scale score (according to participant's level of education)

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618694


Locations
Egypt
Alexandria Main University Hospital
Alexandria, Egypt, 21500
Suez Canal University Hospital
Ismailia, Egypt
Sponsors and Collaborators
Suez Canal University
Alexandria University
Investigators
Study Chair: Sami M Shaaban, Professor Suez Canal University - Department of Urology and Andrology
Study Director: Haitham M Badawy, PhD Alexandria University - Department of Urology
Study Director: Tamer H Abou-Youssif, PhD Alexandria University - Department of Urology
More Information
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Publications:
Doublet, J. D., Janetscek, G., Joyce, A., Mandressi, A., Rassweiller, J., & Tolley, D. (2002). Guidelines in laparoscopy. European Association of Urology.
Eichel, L., & Clayman, R. V. (2012). Fundamentals of laparoscopic and robotic urologic surgery. In A. J. Wein, S. R. Kavoussi, A. C. Novick, A. W. Partin, & C. A. Peters, Campell and Walsh Urology (pp. 204-253). Philadelphia: Saunders.
George, A. K., & Kavoussi, L. R. (2010). Laparoscopic Adrenalectomy. In S. D. Graham, T. E. Keane, S. D. Graham, & T. E. Keane (Eds.), Glenn's Urologic Surgery (pp. 859-866). Phiadelphia: Lippincott Williams and Wilkins.
Linos, D. (2005). Left anterior laparoscopic adrenalectomy. In D. Linos, & J. A. van Heerden, Adrenal Glnads (pp. 320-324). Berlin: Springers.
Linos, D. (2005). Right anterior laparoscopic adrenalectomy. In D. Linos, & J. A. van Heerden, Adrenal Galnd (pp. 313-319). Berlin: Springer.
Linos, D., & van Heerden, J. A. (2005). Adrenal Glands: diagnostic aspects and surgical therapy. Berlin: Springer.
Sam, A., & Meeran, K. (2009). Licture notes: Endocrinology and Diabetes. UK: Wiley-Black Well.
Suzuki, K., Tsuru, N., & Ihara, H. (2012). Laparoscopic approaches for Adrenal galnds. In J. A. Smith, S. S. Howards, & G. M. Preminger, Hinman's Atlas of Urologic Surgery (pp. 1111-1122). Philadilphia: Sunders.
Walz, M. K. (2005). Posterior retroperitoneoscopic adrenalectomy. In D. Linios, & J. A. van Heerden, Adrenal Glands (pp. 333-339). Berlin: Springer.

Responsible Party: Ahmed Mohamed Bakr Arabi, Demonstrator, Suez Canal University
ClinicalTrials.gov Identifier: NCT02618694     History of Changes
Other Study ID Numbers: 2380
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ahmed Mohamed Bakr Arabi, Suez Canal University:
adrenal
supra-renal
adrenalectomy
 retroperitoneoscopy
posterior retroperitoneoscopy
Laparoscopic adrenalectomy

Additional relevant MeSH terms:
Pheochromocytoma
Cushing Syndrome
Adrenal Gland Diseases
Paraganglioma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adrenocortical Hyperfunction
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents