NCT03830593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 7, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2019

Completed
Last Updated

October 10, 2019

Status Verified

December 1, 2018

Enrollment Period

3 months

First QC Date

February 2, 2019

Last Update Submit

October 8, 2019

Conditions

Adrenal TumorAdrenal Adenoma

Keywords

endocrine surgery; laparoscopic adrenalectomy;

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (3)

Group 1

laparoscopic adrenalectomy group 1: tumor size as \< 6 (group1)

Procedure: Laparoscopic Adrenalectomy

Group 2

Laparoscopic adrenalectomy group2: tumor size ≥ 6 cm (group2)

Procedure: Laparoscopic 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

Interventions

Laparoscopic AdrenalectomyPROCEDURE

minimally invasive lateral transperitoneal adrenalectomy

Group 1Group 2Learning Curve

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • American Society of Anesthesiologists score (ASA) ≤ 3.

You may not qualify if:

  • suspicion of malignancy on imaging such as local invasion, irregular tumor margins
  • Retroperitoneoscopic adrenalectomies
  • laparoscopic partial adrenalectomies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Samsun Liv Hospital

Samsun, 55020, Turkey (Türkiye)

Location

Ondokuz Mayıs University

Samsun, 55030, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 27238874BACKGROUND

  • 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.

    PMID: 29325527RESULT

MeSH Terms

Conditions

Adrenal Gland NeoplasmsACTH Syndrome, Ectopic

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Gland DiseasesEndocrine System DiseasesParaneoplastic Endocrine SyndromesParaneoplastic Syndromes

Study Officials

  • Şaban Sarıkaya, Prof. MD

    Ondokuz Mayıs University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 5, 2019

Study Start

February 7, 2019

Primary Completion

May 20, 2019

Study Completion

July 5, 2019

Last Updated

October 10, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)