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

N/AWithdrawnNCT05496244

Intuitive Surgical

Overview

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

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

Study Type

OBSERVATIONAL

Conditions

GYN Disorders

Interventions

LaparoscopyDEVICE

Laparoscopic surgery

Robotic-assisted surgeryDEVICE

Robotic-assisted surgery

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Describe treatment decision

Describe treatment decision for the procedure of choice

Time frame: 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)

Time frame: 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

Time frame: 12 Months

Complications of medical interest

Describe complication of medical interest

Time frame: 90 days

Secondary Outcomes

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)

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.