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

NCT05496244 | Withdrawn FDA Device

• 1 other identifier: 1.0
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

GYN Disorders

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Quality of Life Impact per patient reported questionnaires

  12 Months

• Describe the impact of surgeon experience on outcome

  12 Months

• Describe the performance and use of Intuitive instruments

  12 Months

• Describe the performance and use of Intuitive systems

  12 Months

Study Arms (2)

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; Device: Robotic-assisted surgery

Interventions

Laparoscopy DEVICE

Laparoscopic surgery

Observational Section

Robotic-assisted surgery DEVICE

Robotic-assisted surgery

Observational Section

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Life expectancy for less than 1 year

Sponsors & Collaborators

• Intuitive Surgical: lead

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Laparoscopy; Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Surgery, Computer-Assisted; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Ingolf Juhasz-Böss, Prof. Dr.

  Universitätsklinikum Freiburg, Germany

  PRINCIPAL INVESTIGATOR

• Vincent Lavoué, Prof. Dr.

  CHU de Rennes, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: August 11, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 15, 2023

Record last verified: 2023-06