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Laparoscopic Adrenalectomy for Large Adrenal Tumors.

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ClinicalTrials.gov Identifier: NCT03830593
Recruitment Status : Completed
First Posted : February 5, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Ondokuz Mayıs University
Information provided by (Responsible Party):
Mehmet Necmettin Mercimek, Samsun Liv Hospital

Brief Summary:
Laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm. However, this is an ongoing debate that exact cut-off value of tumor size for LA. The aim of this study was to assess whether the size of the adrenal tumor affects preoperative and postoperative outcomes in patients undergoing laparoscopic transperitoneal adrenalectomy as well as to evaluate the learning curve.

Condition or disease Intervention/treatment
Adrenal Tumor Adrenal Adenoma Procedure: Laparoscopic Adrenalectomy

Detailed Description:

From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent LTA with adrenal mass were recorded prospectively and analyzed retrospectively.

The inclusion criteria were all hormonally active adrenal lesions, detection of increases in size in < 4 cm adrenal tumors on serial imaging, solitary adrenal metastases without evidence of local invasion, tumors size ≥ 4 cm, patients between the age of 18 and 80, and American Society of Anesthesiologists score (ASA) ≤ 3. The patients with adrenal masses that specified suspicion of malignancy on imaging such as local invasion, irregular tumor margins were evaluated as ineligible for LTA, and excluded in this study, were addressed to open surgery. Retroperitoneoscopic and laparoscopic partial adrenalectomies were also excluded from the study.

Totally 102 patients were included in the study. The patients were allocated according to adrenal tumor size as <6cm (group 1:76) and ≥ 6 cm (group 2: 26). The variables such as demographics, tumor size, and laterality, operation time, blood loss, per-operative and postoperative complications, length of hospital stay, final pathology result were compared between the two groups. In order to evaluate the learning curve, the patients were also classified into three consecutive groups including group A (1-25), group B (25-50), group C (51-75) and group D (76-102) according to the chronological order of their surgery. Variables including operation time, tumor size, blood loss, and hospital stay, and overall complications were used to investigate the learning curve.


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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Is There Anything New in the Field of Large Adrenal Tumors ?
Actual Study Start Date : February 7, 2019
Actual Primary Completion Date : May 20, 2019
Actual Study Completion Date : July 5, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
laparoscopic adrenalectomy group 1: tumor size as < 6 (group1)
Procedure: Laparoscopic Adrenalectomy
minimally invasive lateral transperitoneal adrenalectomy

Group 2
Laparoscopic adrenalectomy group2: tumor size ≥ 6 cm (group2)
Procedure: Laparoscopic Adrenalectomy
minimally invasive lateral transperitoneal adrenalectomy

Learning Curve
The patients, underwent laparoscopic adrenalectomy, were also classified into group A (1-25), B (26-50), C (51-75), and D (76-102) according to the chronological order of their surgery in order to evaluate the learning curve.
Procedure: Laparoscopic Adrenalectomy
minimally invasive lateral transperitoneal adrenalectomy




Primary Outcome Measures :
  1. Operation time [ Time Frame: intraoperative (minute) ]
    time from onset to complete of operation

  2. Blood loss [ Time Frame: intraoperative ]
    amount of bleeding during surgery (milliliter)

  3. hospitalization [ Time Frame: 1 day ]
    duration of postoperative hospital stay

  4. Complication [ Time Frame: 1 day ]
    abnormal conditions during or after surgery



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent laparoscopic adrenalectomy
Criteria

Inclusion Criteria:

  1. all hormonally active adrenal lesions,
  2. detection of increases in size in < 4 cm adrenal tumors on serial imaging,
  3. solitary adrenal metastases without evidence of local invasion,
  4. tumors size ≥ 4 cm,
  5. patients between the age of 18 and 80
  6. American Society of Anesthesiologists score (ASA) ≤ 3.

Exclusion Criteria:

  1. suspicion of malignancy on imaging such as local invasion, irregular tumor margins
  2. Retroperitoneoscopic adrenalectomies
  3. laparoscopic partial adrenalectomies

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): NCT03830593


Locations
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Turkey
Samsun Liv Hospital
Samsun, Turkey, 55020
Ondokuz Mayıs University
Samsun, Turkey, 55030
Sponsors and Collaborators
Samsun Liv Hospital
Ondokuz Mayıs University
Investigators
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Study Chair: Şaban Sarıkaya, Prof. MD Ondokuz Mayıs University

Publications of Results:
Other Publications:
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Responsible Party: Mehmet Necmettin Mercimek, MD, Samsun Liv Hospital
ClinicalTrials.gov Identifier: NCT03830593     History of Changes
Other Study ID Numbers: OMU KAEK (2019/78)
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Necmettin Mercimek, Samsun Liv Hospital:
endocrine surgery; laparoscopic adrenalectomy;
Additional relevant MeSH terms:
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Adenoma
Adrenal Gland Neoplasms
Adrenocortical Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Gland Diseases
Endocrine System Diseases
Adrenal Cortex Neoplasms
Adrenal Cortex 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