Efficacy and Safety of Posterior Retroperitoneoscopic Adrenalectomy: A Comparative Study

NCT02618694 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

  • Adrenal Mass
  • Adrenal Disease
  • Pheochromocytoma
  • Cushing Syndrome

Interventions

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).

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).

Sponsors & Collaborators

  • Alexandria University

    collaborator OTHER
  • Suez Canal University

    lead OTHER

Principal Investigators

  • Sami M Shaaban, Professor · Suez Canal University - Department of Urology and Andrology

  • Haitham M Badawy, PhD · Alexandria University - Department of Urology

  • Tamer H Abou-Youssif, PhD · Alexandria University - Department of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-06-30
Completion
2016-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02618694 on ClinicalTrials.gov