ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy (ROBYN)

ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy - A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation

Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy

Study Overview

• Status: Withdrawn
• Conditions: GYN Disorders
• Intervention / Treatment: Device: Laparoscopy; Device: Robotic-assisted surgery

Detailed Description

A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients present with gynecological disease that may be treated by surgical intervention

Description

Key Inclusion Criteria:

• Patient is willing to participate and to comply with the study procedures
• Patient present with gynecological disease that may be treated with surgical intervention

Key Exclusion Criteria:

• Life expectancy for less than 1 year

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epidemiological Section; Consecutive enrollment of patients with indications of interest
Observational Section; Extended data collection on patients treated via conventional laparoscopy or robotic-assisted surgery	Device: Laparoscopy; Laparoscopic surgery; Device: Robotic-assisted surgery; Robotic-assisted surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe treatment decision	Describe treatment decision for the procedure of choice	Enrollment Completion
Describe patient outcome	Describe patient outcome from robotic-assisted surgery and conventional laparoscopy by using physiological parameter such as relief or improvement of symptoms, number of complications or number of re-operations and changes in the patient reported quality of life (EQ-5D-5L) between baseline and FU at 12 Months (changes in the score)	12 Months
Describe impact of patient factors on outcome	Describe impact of patient factors on outcome by using physiological parameter, such as age, BMI, uterus size, report co-morbidities	12 Months
Complications of medical interest	Describe complication of medical interest	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Impact per patient reported questionnaires	Describe Quality of Life impact as assessed via patient reported questionnaires; changes in quality of life questionnaires scores between baseline and up to follow-up 12 months will be assessed (EQ-5D-5L on mobility, self-care, usual activities, pain/discomfort, anxiety/depression)	12 Months
Describe the impact of surgeon experience on outcome	Describe the impact of surgeon experience on outcome; individual surgeon experience will be collected (self-reported by surgeon) and linked to every performed procedure; descriptive assessment if the reported surgeon experience has an impact on the outcome, e.g. number of reported complications. As surgeon experience, the number of performed procedures per indication and technique (robotic-assisted surgery or laparoscopy will be collected), as well as the overall years the surgeon is performing surgeries.	12 Months
Describe the performance and use of Intuitive instruments	Describe the performance and use of Intuitive instruments; information on any device failure or device deficiency will be collected and descriptively assessed	12 Months
Describe the performance and use of Intuitive systems	Describe the performance and use of Intuitive systems; information on any device failure or device deficiency will be collected and descriptively assessed	12 Months

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Ingolf Juhasz-Böss, Prof. Dr., Universitätsklinikum Freiburg, Germany; Principal Investigator: Vincent Lavoué, Prof. Dr., CHU de Rennes, France

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female
• Other Study ID Numbers: 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes