A Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery (3DAdrenal)

3D is Better for Adrenal: a Randomized Clinical Trial About Use of 3D Laparoscopy Versus 2D Laparoscopy in Adrenal Surgery

Comparison between 2D traditional laparoscopic surgery and 3D laparoscopy for adrenal surgery.

Study Overview

• Status: Completed
• Conditions: Adrenal Gland Neoplasms; Adrenal Adenoma; Adrenal Mass
• Intervention / Treatment: Procedure: laparoscopic adrenalectomy

Detailed Description

Laparoscopic adrenalectomy is today considered the gold standard of treatment for adrenal tumors. This technique was described for the first time by Gagner in 1992 and in the past years several studies have shown the advantages of laparoscopic approach with decrease of the perioperative morbidity, lower complication rates, less operative blood loss, less postoperative pain and shorter hospital stay compared with open adrenalectomy. Laparoscopic surgery is more difficult to learn and requires different psychomotor skills than open laparotomy. In fact, the surgeons have to work in a three-dimensional space, but are guided by two-dimensional images. The development of high definition cameras does not eliminate the major limitation of two-dimensional (2D) laparoscopy: lack of depth perception and lose of spatial orientation with potential increasing the strain for the surgeon, the risk of errors and the operative time. Three-dimensional (3D) HD laparoscopy was developed as an alternative to conventional 2D laparoscopy.

In literature there are still few clinical studies on use of 3D in laparoscopic adrenalectomies with different results.

For these reasons the investigators propose an international multicenter study to compare 3D laparoscopic adrenalectomy with standard laparoscopic adrenalectomy.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90127
    • Italy
  • PA
    • Palermo, PA, Italy, 90144
      • Giuseppe Di Buono

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients competent to give consent
• aged between 18 and 85 years
• functioning and not functioning benign adrenal lesions,
• adrenal malignancies candidate to laparoscopic adrenal surgery.

Exclusion Criteria:

• open adrenal surgery
• preoperative signs of local periadrenal invasiveness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2D group; patients underwent to 2D laparoscopic adrenalectomy for adrenal mass.	Procedure: laparoscopic adrenalectomy; laparoscopic adrenalectomy
Experimental: 3D group; patients underwent to 3D laparoscopic adrenalectomy for adrenal mass.	Procedure: laparoscopic adrenalectomy; laparoscopic adrenalectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
periperative surgical outcomes	evaluation of intraoperative surgical complication during laparoscopic adrenalectomy with YES or NO and questionnaire about resolution of complications. In details the investigators evaluates: vascular complications (Major lesions: renal artery, renal vein; aorta; vena cava; sovrahepatic veins. Minor lesions: adrenal vessels; accessory renal vessels; others); complication hollow viscus (bowel; colonic; stomach; urether); complication parenchymatous viscus (renal; adrenal; spleen; diaphragm); resolution of complications; conversion to open surgery. 30-day postoperative complications (only grade 3 - 4 - 5 sec. Clavien-Dindo classification)	30-postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
depth perception	evaluation of depth perception during surgical procedure with a questionnaire administered to surgical team with a score from 1 (min depth) to 5 (max depth)	intraoperatory time
definition of surgical plane	definition of surgical plane during surgery with a questionnaire administered to surgical team with a score from 1 (min definition) to 5 (max definition)	intraoperatory time
evaluation of surgical strain	variables of surgical strain: wrist, hand, neck, back, dizziness and/or headache (Yes=1; No=0).	intraoperatory time

Collaborators and Investigators

• Sponsor: University of Palermo

Publications and helpful links

General Publications

• Agrusa A, di Buono G, Chianetta D, Sorce V, Citarrella R, Galia M, Vernuccio L, Romano G, Gulotta G. Three-dimensional (3D) versus two-dimensional (2D) laparoscopic adrenalectomy: A case-control study. Int J Surg. 2016 Apr;28 Suppl 1:S114-7. doi: 10.1016/j.ijsu.2015.12.055. Epub 2015 Dec 18.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: August 17, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic adrenalectomy; adrenal surgery
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Cortex Neoplasms; Adrenal Cortex Diseases; Adenoma; Adrenal Gland Neoplasms; Adrenocortical Adenoma
• Other Study ID Numbers: 3D is better

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: databse is in the possession of the corresponding author and available upon request after publication of research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No