Efficacy and Safety of Posterior Retroperitoneoscopic Adrenalectomy: A Comparative Study (PostLapAdrnl)
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| ClinicalTrials.gov Identifier: NCT02618694 |
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Recruitment Status :
Completed
First Posted : December 1, 2015
Last Update Posted : March 3, 2017
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Sponsor:
Suez Canal University
Collaborator:
Alexandria University
Information provided by (Responsible Party):
Ahmed Mohamed Bakr Arabi, Suez Canal University
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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 |
Show Detailed Description
| 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
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1
patient had posterior retroperitoneoscopic adrenalectomy
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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 |
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Active Comparator: Group 2
patient had Transperitoneal laparoscopic adrenalectomy
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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:
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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
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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.
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 |
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:
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adrenal supra-renal adrenalectomy |
retroperitoneoscopy posterior retroperitoneoscopy Laparoscopic adrenalectomy |
Additional relevant MeSH terms:
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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 |