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

Withdrawn

• Conditions: GYN Disorders
• Interventions: Device: Laparoscopy; Device: Robotic-assisted surgery

• Registration Number: NCT05496244
• Lead Sponsor: Intuitive Surgical

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-11
• Study Start: 2022-11
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15
• Primary Completion: 2026-11
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Life expectancy for less than 1 year

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Section	Robotic-assisted surgery	Extended data collection on patients treated via conventional laparoscopy or robotic-assisted surgery
Observational Section	Laparoscopy	Extended data collection on patients treated via conventional laparoscopy or robotic-assisted surgery

Primary Outcome Measures

Name	Time	Method
Describe patient outcome	12 Months	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)
Describe impact of patient factors on outcome	12 Months	Describe impact of patient factors on outcome by using physiological parameter, such as age, BMI, uterus size, report co-morbidities
Describe treatment decision	Enrollment Completion	Describe treatment decision for the procedure of choice
Complications of medical interest	90 days	Describe complication of medical interest

Secondary Outcome Measures

Name	Time	Method
Quality of Life Impact per patient reported questionnaires	12 Months	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)
Describe the impact of surgeon experience on outcome	12 Months	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.
Describe the performance and use of Intuitive systems	12 Months	Describe the performance and use of Intuitive systems; information on any device failure or device deficiency will be collected and descriptively assessed
Describe the performance and use of Intuitive instruments	12 Months	Describe the performance and use of Intuitive instruments; information on any device failure or device deficiency will be collected and descriptively assessed