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

NCT06576336 | Completed Phase 4

• 1 other identifier: 3D is better
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Adrenal Mass; Adrenal Adenoma; Adrenal Gland Neoplasms

Keywords

adrenal surgery; laparoscopic adrenalectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• depth perception

  intraoperatory time

• definition of surgical plane

  intraoperatory time

• evaluation of surgical strain

  intraoperatory time

Study Arms (2)

2D group

ACTIVE COMPARATOR

patients underwent to 2D laparoscopic adrenalectomy for adrenal mass.

Procedure: laparoscopic adrenalectomy

3D group

EXPERIMENTAL

patients underwent to 3D laparoscopic adrenalectomy for adrenal mass.

Procedure: laparoscopic adrenalectomy

Interventions

laparoscopic adrenalectomy PROCEDURE

laparoscopic adrenalectomy

2D group; 3D group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• open adrenal surgery
• preoperative signs of local periadrenal invasiveness

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (2)

Giuseppe Di Buono

Palermo, PA, 90144, Italy

Location

Italy

Palermo, 90127, Italy

Location

Related Publications (1)

• 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.

  PMID: 26708842 RESULT

MeSH Terms

Conditions

ACTH Syndrome, Ectopic; Adrenal Gland Neoplasms

Condition Hierarchy (Ancestors)

Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Surgery

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 28, 2024
• Study Start: January 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)