Clinical trial NCT03830593: Laparoscopic Adrenalectomy for Large Adrenal Tumors.
Official title: Is There Anything New in the Field of Large Adrenal Tumors ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Tumor
Adrenal Adenoma
Keywords: endocrine surgery; laparoscopic adrenalectomy;
Lead sponsor: Samsun Liv Hospital
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2019-02-05
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From April 2010 to October 2018, preoperative and postoperative data of 107 patients who underwent laparoscopic adrenalectomy

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.

Eligibility 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

Primary outcomes:
measure: Operation time
timeFrame: intraoperative (minute)
measure: Blood loss
timeFrame: intraoperative
measure: hospitalization
timeFrame: 1 day
measure: Complication
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun Liv Hospital
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: Şaban Sarıkaya, Prof. MD
role: STUDY_CHAIR
References:
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.
citation: 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.