NCT02618694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

November 15, 2015

Last Update Submit

March 1, 2017

Conditions

Adrenal MassAdrenal DiseasePheochromocytomaCushing Syndrome

Keywords

adrenalsupra-renaladrenalectomyretroperitoneoscopyposterior retroperitoneoscopyLaparoscopic adrenalectomy

Outcome Measures

Primary Outcomes (4)

  • 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

  • Mean amount of intraoperative blood loss

    measured in milliliters.

    1 year

  • 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

  • Rate of complications

    classified by Clavien-Dindo classification system

    1.5 year

Secondary Outcomes (2)

  • Mean of postoperative pain score

    1 year

  • mean of scar cosmetic assessment score

    1.1 year

Study Arms (2)

Group 1

EXPERIMENTAL

patient had posterior retroperitoneoscopic adrenalectomy

Procedure: Posterior retroperitoneoscopic adrenalectomy

Group 2

ACTIVE COMPARATOR

patient had Transperitoneal laparoscopic adrenalectomy

Procedure: Transperitoneal laparoscopic adrenalectomy

Interventions

Posterior retroperitoneoscopic adrenalectomyPROCEDURE

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).

Also known as: Posterior retroperitoneal laparoscopic adrenalectomy
Group 1
Transperitoneal laparoscopic adrenalectomyPROCEDURE

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).

Also known as: Anterior laparoscopic adrenalectomy, Lateral laparoscopic adrenalectomy
Group 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alexandria Main University Hospital

Alexandria, Alexandria Governorate, 21500, Egypt

Location

Suez Canal University Hospital

Ismailia, Ismailia Governorate, Egypt

Location

Related Publications (18)

  • 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.

    PMID: 23023976BACKGROUND

  • 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.

    PMID: 21878230BACKGROUND

  • 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.

    PMID: 21463807BACKGROUND

  • Doublet, J. D., Janetscek, G., Joyce, A., Mandressi, A., Rassweiller, J., & Tolley, D. (2002). Guidelines in laparoscopy. European Association of Urology.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.1097/01.sla.0000193806.81428.6f.

    PMID: 16371735BACKGROUND

  • 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.

    BACKGROUND

  • Linos, D. (2005). Left anterior laparoscopic adrenalectomy. In D. Linos, & J. A. van Heerden, Adrenal Glnads (pp. 320-324). Berlin: Springers.

    BACKGROUND

  • Linos, D. (2005). Right anterior laparoscopic adrenalectomy. In D. Linos, & J. A. van Heerden, Adrenal Galnd (pp. 313-319). Berlin: Springer.

    BACKGROUND

  • Linos, D., & van Heerden, J. A. (2005). Adrenal Glands: diagnostic aspects and surgical therapy. Berlin: Springer.

    BACKGROUND

  • 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. doi: 10.1016/j.urology.2006.11.005.

    PMID: 17382144BACKGROUND

  • 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. doi: 10.1046/j.1464-410x.2002.02845.x.

    PMID: 12133053BACKGROUND

  • 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.

    PMID: 21856076BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 10737474BACKGROUND

  • 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.

    BACKGROUND

  • Walz, M. K. (2005). Posterior retroperitoneoscopic adrenalectomy. In D. Linios, & J. A. van Heerden, Adrenal Glands (pp. 333-339). Berlin: Springer.

    BACKGROUND

  • 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. doi: 10.1016/j.surg.2006.07.039.

    PMID: 17188142BACKGROUND

MeSH Terms

Conditions

Adrenal Gland DiseasesPheochromocytomaCushing Syndrome

Condition Hierarchy (Ancestors)

Endocrine System DiseasesParagangliomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueAdrenocortical Hyperfunction

Study Officials

  • Sami M Shaaban, Professor

    Suez Canal University - Department of Urology and Andrology

    STUDY CHAIR

  • Haitham M Badawy, PhD

    Alexandria University - Department of Urology

    STUDY DIRECTOR

  • Tamer H Abou-Youssif, PhD

    Alexandria University - Department of Urology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

November 15, 2015

First Posted

December 1, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

EG(2)