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

Pelvic Organ Prolapse Clinical Trial

— PARSEC  

Official title:

Prospective Interventional Study on Robotic Sacrocolpopexy: a European Multicentric Cohort (PARSEC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01598467
• Other study ID #: PARSEC-1
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2012
• Last updated: February 15, 2018
• Start date: August 2011
• Est. completion date: August 2022

Study information

• Verified date: February 2018
• Source: Cork University Hospital
• Contact: Lorenzo Dutto, MD
• Phone: 00353-833247511
• Email: lorenzo.dutto[@]fastwebnet.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Ireland	Cork University Maternity Hospital	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Femke van Zanten

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)	anatomical cure (defined as any simplified POP-Q point <2) will be assessed at regular intervals(see time frame). If any postoperative POP-Q point will be =2, this will be recorded as a recurrent prolapse.	6 months
Secondary	intra- peri- and postoperative complications	complications occurring during surgery are defined as "intraoperative complication", within 3 weeks from surgery will be defined as "perioperative complication". Complications occurring after this timeframe will be regarded as "late complications", if related to surgery (e.g. mesh erosion)	intraoperative to 6 weeks after surgery
Secondary	quality of life	impact of prolapse repair on quality of life will be assessed via specific validated questionnaires (PFIQ-7, PISQ-12)	6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
Secondary	postoperative pain	pain will be assessed on a visual analogue scale (range 0 to 10= 0 no pain, 10 unbearable pain)	on postoperative day 1
Secondary	intraoperative variables	intraoperative variables are recorded, such as: blood loss, duration of surgery (divided in robotic setup time, console time and surgery completion time). Concomitant procedures, such as adhesiolysis will also be recorded	intraoperative
Secondary	impact of uterus management	logistic regression analysis will be performed to evaluate if different surgical approaches in presence, -or absence, of the uterus (e.g. supracervical hysterectomy, uterus sparing surgery), have an effect on primary and secondary outcomes	6 weeks, 6 months, 1 year (yearly thereafter, if feasible)
Secondary	anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)	anatomical cure (defined as any simplified POP-Q point <2) will be assessed at regular intervals(see time frame). If any postoperative POP-Q point will be =2, this will be recorded as a recurrent prolapse.	6 weeks
Secondary	anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)	anatomical cure (defined as any simplified POP-Q point <2) will be assessed at regular intervals(see time frame). If any postoperative POP-Q point will be =2, this will be recorded as a recurrent prolapse.	1 year, yearly thereafter (if feasible)