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

Not Applicable
Conditions
Pelvic Organ Prolapse
Registration Number
NCT01598467
Lead Sponsor
Femke van Zanten
Brief 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.

Detailed 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 & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
300
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)6 months

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.

Secondary Outcome Measures
NameTimeMethod
intra- peri- and postoperative complicationsintraoperative to 6 weeks after surgery

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)

quality of life6 weeks, 6 months, 1 year (yearly thereafter, if feasible)

impact of prolapse repair on quality of life will be assessed via specific validated questionnaires (PFIQ-7, PISQ-12)

intraoperative variablesintraoperative

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

anatomical cure after robotic assisted sacrocolpopexy (or absence of recurrent prolapse)1 year, yearly thereafter (if feasible)

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.

impact of uterus management6 weeks, 6 months, 1 year (yearly thereafter, if feasible)

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

postoperative painon postoperative day 1

pain will be assessed on a visual analogue scale (range 0 to 10= 0 no pain, 10 unbearable pain)

Trial Locations

Locations (1)

Cork University Maternity Hospital

🇮🇪

Cork, Ireland

Cork University Maternity Hospital
🇮🇪Cork, Ireland
Lorenzo Dutto, MD
Contact
00353(83)3247511
lorenzo.dutto@fastwebnet.it
Barry O'Reilly
Principal Investigator

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