Laparoscopic Adrenalectomy for Large Adrenal Tumors.

Is There Anything New in the Field of Large Adrenal Tumors ?

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.

Study Overview

• Status: Completed
• Conditions: Adrenal Tumor; Adrenal Adenoma
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Turkey
  • Samsun, Turkey, 55020
    • Samsun Liv Hospital
  • Samsun, Turkey, 55030
    • Ondokuz Mayıs University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent laparoscopic adrenalectomy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	time from onset to complete of operation	intraoperative (minute)
Blood loss	amount of bleeding during surgery (milliliter)	intraoperative
hospitalization	duration of postoperative hospital stay	1 day
Complication	abnormal conditions during or after surgery	1 day

Collaborators and Investigators

• Sponsor: Samsun Liv Hospital
• Collaborators: Ondokuz Mayıs University
• Investigators: Study Chair: Şaban Sarıkaya, Prof. MD, Ondokuz Mayıs University

Publications and helpful links

General Publications

• Huynh KT, Lee DY, Lau BJ, Flaherty DC, Lee J, Goldfarb M. Impact of Laparoscopic Adrenalectomy on Overall Survival in Patients with Nonmetastatic Adrenocortical Carcinoma. J Am Coll Surg. 2016 Sep;223(3):485-92. doi: 10.1016/j.jamcollsurg.2016.05.015. Epub 2016 May 26.
• Conzo G, Gambardella C, Candela G, Sanguinetti A, Polistena A, Clarizia G, Patrone R, Di Capua F, Offi C, Musella M, Iorio S, Bellastella G, Pasquali D, De Bellis A, Sinisi A, Avenia N. Single center experience with laparoscopic adrenalectomy on a large clinical series. BMC Surg. 2018 Jan 11;18(1):2. doi: 10.1186/s12893-017-0333-8.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2019
• Primary Completion (Actual): May 20, 2019
• Study Completion (Actual): July 5, 2019

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: endocrine surgery; laparoscopic adrenalectomy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Cortex Neoplasms; Adrenal Cortex Diseases; Adenoma; Adrenal Gland Neoplasms; Adrenocortical Adenoma
• Other Study ID Numbers: OMU KAEK (2019/78)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No