NCT05853302

Brief Summary

This retrospective study evaluates the safety and the effectiveness of robotic adrenalectomy when compared to laparoscopic approach in patients who underwent minimally-invasive lateral transperitoneal unilateral adrenalectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 2, 2025

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

May 2, 2023

Last Update Submit

August 25, 2025

Conditions

Adrenalectomy; Status

Keywords

minimally-invasive surgeryrobotic surgerylateral transabdominal adrenalectomy

Outcome Measures

Primary Outcomes (1)

  • Post-operative complications

    Evaluation of post-operative complications within 30 days from adrenalectomy

    June 1997-December 2021

Secondary Outcomes (2)

  • Mortality

    June 1997-December 2021

  • Robotic procedure effectiveness

    June 1997-December 2021

Study Arms (2)

Laparoscopic TLA

Patients who underwent laparoscopic lateral transabdominal unilateral adrenalectomy

Robotic TLA

Patients who underwent robotic lateral transabdominal unilateral adrenalectomy

Eligibility Criteria

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

In consideration of the 15%-minimally invasive procedure-related morbidity rate (both with laparoscopic and robotic approach), the 5%-significativity, the 80%-study power and the 10%-non-inferiority limit, the sample size is 316 patients. Such sample size is divided in 15 patients per group (Sealed Envelope Ltd. 2012. Power calculator for binary outcome noninferiority trial. \[Online\] Available from: https://www.sealedenvelope.com/power/binary-noninferior/ \[Accessed Mon Jan 31 2022\]).

You may qualify if:

  • Patients who underwent minimally-invasive unilateral adrenalectomy with lateral transabdominal approach between June 1st 1997 and December 31st 2021

You may not qualify if:

  • Patients who underwent bilateral or retroperitoneoscopic adrenalectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

Study Officials

  • Marco Raffaelli, Prof

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 10, 2023

Study Start

December 15, 2022

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

September 2, 2025

Record last verified: 2023-02

Locations

IT(1)