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Completed

NCT Number: NCT03830593

Laparoscopic Adrenalectomy for 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuz Mayıs University, Samsun, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

laparoscopic adrenalectomy

Procedure

minimally invasive lateral transperitoneal adrenalectomy

Primary outcomes

  1. Operation time

    Time frame: intraoperative (minute)

    time from onset to complete of operation

  2. Blood loss

    Time frame: intraoperative

    amount of bleeding during surgery (milliliter)

  3. hospitalization

    Time frame: 1 day

    duration of postoperative hospital stay

  4. Complication

    Time frame: 1 day

    abnormal conditions during or after surgery

Sponsors and collaborators

Lead sponsor

Samsun Liv Hospital

Other

Collaborators

  • Ondokuz Mayıs University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2019
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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