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

GYN Disorders Clinical Trial

— ROBYN  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05496244
• Other study ID #: 1.0
• Status: Withdrawn
• Start date: November 2022
• Est. completion date: December 2030

Study information

• Verified date: June 2023
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2030
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• GYN Disorders

Intervention

Device:
• Laparoscopy
Laparoscopic surgery
• Robotic-assisted surgery
Robotic-assisted surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe treatment decision	Describe treatment decision for the procedure of choice	Enrollment Completion
Primary	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
Primary	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
Primary	Complications of medical interest	Describe complication of medical interest	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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