Laparoscopic Adrenalectomy for Large Adrenal Tumors.

Adrenal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830593
• Other study ID #: OMU KAEK (2019/78)
• Status: Completed
• Start date: February 7, 2019
• Est. completion date: July 5, 2019

Study information

• Verified date: December 2018
• Source: Samsun Liv Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 5, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adrenal Adenoma
• Adrenal Gland Neoplasms
• Adrenal Tumor
• Adrenocortical Adenoma

Intervention

Procedure:
• Laparoscopic Adrenalectomy
minimally invasive lateral transperitoneal adrenalectomy

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun
Turkey	Samsun Liv Hospital	Samsun

Sponsors (2)

Lead Sponsor	Collaborator
Samsun Liv Hospital	Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 c — View Citation

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. — View Citation

Outcome

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