Laparoscopic Adrenalectomy for Large Adrenal Tumors.

Completed

• Conditions: Adrenal Adenoma; Adrenal Tumor
• Interventions: Procedure: Laparoscopic Adrenalectomy

• Registration Number: NCT03830593
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2018-12
• Study First Submitted: 2019-02-02
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Study Start: 2019-02-07
• Primary Completion: 2019-05-20
• Study Completion: 2019-07-05
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Laparoscopic Adrenalectomy	laparoscopic adrenalectomy group 1: tumor size as \< 6 (group1)
Group 2	Laparoscopic Adrenalectomy	Laparoscopic adrenalectomy group2: tumor size ≥ 6 cm (group2)
Learning Curve	Laparoscopic Adrenalectomy	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.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Ondokuz Mayıs University; 🇹🇷 Samsun, Turkey

Samsun Liv Hospital; 🇹🇷 Samsun, Turkey