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

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

Show Detailed Description

Study Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Cushing disease

Genetic and Rare Diseases Information Center resources: Pheochromocytoma Cushing's Syndrome Paragangliomas 1 Carotid Body Tumor Neuroendocrine Tumor Neuroepithelioma Hyperadrenalism

U.S. FDA Resources

Arms and Interventions

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

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

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
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

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

Publications:

Constantinides VA, Christakis I, Touska P, Palazzo FF. Systematic review and meta-analysis of retroperitoneoscopic versus laparoscopic adrenalectomy. Br J Surg. 2012 Dec;99(12):1639-48. doi: 10.1002/bjs.8921. Epub 2012 Sep 28. Review.

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.

Dickson PV, Jimenez C, Chisholm GB, Kennamer DL, Ng C, Grubbs EG, Evans DB, Lee JE, Perrier ND. Posterior retroperitoneoscopic adrenalectomy: a contemporary American experience. J Am Coll Surg. 2011 Apr;212(4):659-65; discussion 665-7. doi: 10.1016/j.jamcollsurg.2010.12.023.

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.

Ekstein P, Szold A, Sagie B, Werbin N, Klausner JM, Weinbroum AA. Laparoscopic surgery may be associated with severe pain and high analgesia requirements in the immediate postoperative period. Ann Surg. 2006 Jan;243(1):41-6.

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.

Manabe D, Saika T, Ebara S, Uehara S, Nagai A, Fujita R, Irie S, Yamada D, Tsushima T, Nasu Y, Kumon H; Okayama Urological Research Group, Okayama, Japan. Comparative study of oncologic outcome of laparoscopic nephroureterectomy and standard nephroureterectomy for upper urinary tract transitional cell carcinoma. Urology. 2007 Mar;69(3):457-61.

Naya Y, Nagata M, Ichikawa T, Amakasu M, Omura M, Nishikawa T, Yamaguchi K, Ito H. Laparoscopic adrenalectomy: comparison of transperitoneal and retroperitoneal approaches. BJU Int. 2002 Aug;90(3):199-204.

Park SK, Olweny EO, Best SL, Tracy CR, Mir SA, Cadeddu JA. Patient-reported body image and cosmesis outcomes following kidney surgery: comparison of laparoendoscopic single-site, laparoscopic, and open surgery. Eur Urol. 2011 Nov;60(5):1097-104. doi: 10.1016/j.eururo.2011.08.007. Epub 2011 Aug 12.

Sam, A., & Meeran, K. (2009). Licture notes: Endocrinology and Diabetes. UK: Wiley-Black Well.

Shalhav AL, Dunn MD, Portis AJ, Elbahnasy AM, McDougall EM, Clayman RV. Laparoscopic nephroureterectomy for upper tract transitional cell cancer: the Washington University experience. J Urol. 2000 Apr;163(4):1100-4. Review.

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.

Walz MK, Alesina PF, Wenger FA, Deligiannis A, Szuczik E, Petersenn S, Ommer A, Groeben H, Peitgen K, Janssen OE, Philipp T, Neumann HP, Schmid KW, Mann K. Posterior retroperitoneoscopic adrenalectomy--results of 560 procedures in 520 patients. Surgery. 2006 Dec;140(6):943-8; discussion 948-50.


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

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