GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

Recruiting

• Conditions: GYN Disorders
• Interventions: Device: Robotic-assisted surgery (da Vinci); Device: Non-da Vinci Surgery

• Registration Number: NCT05867927
• Lead Sponsor: Intuitive Surgical

Brief Summary

GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications

Generate real-world evidence in the use of the da Vinci Xi/X Surgical Systems for gynecological indications within the German health care system.

Detailed Description

A prospective, non-interventional, multi-center, post market clinical study.

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-10
• Study First Posted: 2023-05-22
• Study Start: 2023-10-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2027-03
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1125

Inclusion Criteria

• Woman with 18 years of age or older
• Patient is willing to participate and to comply with the study procedures as demonstrated by signing the informed consent
• Patient is a candidate for a gynecological procedure to be performed with the Intuitive Surgical System

Key

Read More

Exclusion Criteria

• Life expectancy of less than 1 year
• Pregnancy, or positive pregnancy test for women prior to menopause or breastfeeding women
• Current participation in a clinical study, if not pre-approved by Intuitive
• Individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate (mentally or verbally), or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliation

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
da Vinci Patients	Robotic-assisted surgery (da Vinci)	Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery
Epidemiological Data Audit	Non-da Vinci Surgery	Extended data collection on patients with indications of interest, eligible for a robotic-assisted surgery, but treatment choice was not a da Vinci surgery

Primary Outcome Measures

Name	Time	Method
Describe the number of patient-reported outcomes up to 12 months	12 months	Describe the patient-reported outcomes up to 12 months; descriptive analysis will be performed on the data directly reported via the patients (patient questionnaires); information included are number of complications, re-hospitalizations, re-operations, disease recurrence, disease remission, new disease diagnosis and pain status including pain medication
Characterize the treatment decision as reported by the treating physician	30 days	Characterize the treatment decision per data provided by the treating physician (within the study database) including the rationale given for the treatment decision (e.g., age of the patient or co-morbidity); number of treatment decisions, e.g., for surgical therapy (open surgery or minimal-invasive therapy), watchful waiting, or treatment with medication will be described; descriptive analysis will be performed
Number of complications related to the surgery up to 30 days	30 days	Describe the number of complications related to the surgery up to 30 days; adverse events as documented during the first 30 days will be classified as four different levels of causality to the surgery (not related, possible, probable and causal relationship). Descriptive analysis will be performed.

Secondary Outcome Measures

Name	Time	Method
Describe the number of Intuitive instruments used per procedure and patient characteristics	30 days	Describe the number of Intuitive instruments used per procedure and patient characteristics; descriptive analysis will be performed on the number of instruments used per specific procedure and patient
Investigate the impact of patient characteristics on surgery	30 days	Descriptive analysis of patient characteristics such as age on surgery (e.g., duration of surgery, instrument usage)
Investigate the impact of patient characteristics on clinical outcome	30 days	Descriptive analysis of patient characteristics such as age on clinical outcome (e.g., re-operation)
Investigate the impact of patient characteristics on complications	30 days	Descriptive analysis of patient characteristics such as age on complication (number of complications reported during and after the surgery)
Describe the impact from surgery to the patient's quality of life and function	12 months	Describe the impact from surgery to the patient's quality of life and function by comparing the baseline quality of life and functional status with the post-operative status (post-operative day 1-3, 30 days, 90 days, 6 months and 12 months)
Describe the number of disease recurrence and re-operation at final patient follow-up	12 months	Describe the number disease recurrence and re-operation at final patient follow-up; descriptive analysis will be performed
Describe the number of conversion per procedure and patient characteristics	30 days	Describe the number conversion per procedure and patient characteristics; descriptive analysis will be performed
Describe the impact of surgeon experience on surgical times (duration of surgery per treating surgeon)	30 days	Describe the impact of surgeon experience on surgical times, descriptive analysis will be performed on the surgical times (duration of surgery) per treating surgeon
Describe the impact of surgeon experience on clinical outcome (number of clinical outcomes per treating surgeon)	30 days	Describe the impact of surgeon experience on clinical outcome; descriptive analysis will be performed, e.g., on number of re-operation or re-hospitalization per treating surgeon
Describe the impact of surgeon experience on complications (number of events per surgeon)	30 days	Describe the impact of surgeon experience on complications; descriptive analysis will be performed on number of adverse events per treating surgeon

Trial Locations

Locations (6)

Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie; 🇩🇪 Berlin, Germany

Universitätsklinikum Freiburg - Klinik für Frauenheilkunde; 🇩🇪 Freiburg, Germany

Klinikum Nürnberg Nord / Klinik für Frauenheilkunde; 🇩🇪 Nürnberg, Germany

St. Elisabeth-Krankenhaus Köln-Hohenlind; 🇩🇪 Köln, Germany

Albertinen Krankenhaus Hamburg; 🇩🇪 Hamburg, Germany

Universitätsklinikum Tübingen - Frauenklinik; 🇩🇪 Tübingen, Germany