Prospective Assessment of Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2022-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

NCT01805310

Pelvic Organ Prolapse Prolapse

COMPLETED PHASE4

Day Case Laparoscopic Sacrocolpopexy, a New Management

NCT03607344

Pelvic Organ Prolapse

COMPLETED

Early Safety of Resection Recopy and Sacrocolpopexy

NCT05910021

Constipation by Outlet Obstruction Pelvic Organ Prolapse Urinary Incontinence

COMPLETED

Standardizing Right Hemicolectomy for Colon Cancer

NCT04889456

Colonic Carcinoma Laparoscopic Right Hemicolectomy Standardisation +5 more

NOT_YET_RECRUITING NA

Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele

NCT05894226

Rectocele Obstructive Defecation Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers.

Primary outcome: anatomical cure rate (using simplified POP-Q staging system)

Secondary outcomes:

complication assessment (Clavien-Dindo), functional results, intraoperative variables, impact of surgery on quality of life (PFIQ-7, PISQ-12)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Organ Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women with pelvic organ prolapse

Women with pelvic organ prolapse (simplified POP-Q \> stage 1)

Group Type OTHER

Robotic assisted sacrocolpopexy (RASC)

Intervention Type PROCEDURE

Robotic assisted sacrocolpopexy (RASC) will be performed with the Da Vinci Surgical robot (Intuitive Surgical). THe mesh used will be a Type I (Amid classification), polypropylene mesh

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robotic assisted sacrocolpopexy (RASC)

Robotic assisted sacrocolpopexy (RASC) will be performed with the Da Vinci Surgical robot (Intuitive Surgical). THe mesh used will be a Type I (Amid classification), polypropylene mesh

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sacrocolpopexy, colpopexy, promontofixation, hysteropexy, colposacrohysteropexy, sacropexy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Symptomatic vaginal vault prolapse with simplified pelvic organ prolapse quantification (POP-Q) stage 2 or greater

Exclusion Criteria

* Poor health status with inability to undergo general anaesthesia
* Age \< 18 years
* ≥ 3 previous laparotomic surgeries
* Planned pregnancy
* Other: known pelvic malignancies, previous pelvic radiotherapy, congenital anomalies of genitourinary tract, autoimmune diseases with connective tissue involvement (Lupus, Sjogren Sdr, sclerodermia, etc.), current UTI's, use of steroids, anticoagulants, interstitial cystitis

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No