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Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy

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ClinicalTrials.gov Identifier: NCT02741830
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

Tracking Information
First Submitted Date April 13, 2016
First Posted Date April 18, 2016
Last Update Posted Date January 10, 2019
Actual Study Start Date April 7, 2016
Actual Primary Completion Date May 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2016)
Subject patient symptoms of prolapse, "bulge" symptom [ Time Frame: 3-7 years after reconstructive surgery involving uterosacral ligament suspension or robotic sacrocolpopexy ]
This is a binary outcome, and success is defined as answering "No" to question #3 on the Pelvic Organ Prolapse Distress Inventory (PFDI-20) questionnaire, as well as the absence of any reoperation or pessary use for pelvic organ prolapsed.
Original Primary Outcome Measures
 (submitted: April 13, 2016)
Subject patient symptoms of prolapse, "bulge" symptom [ Time Frame: 3-7 years after reconstructive surgery involving uterosacral ligament suspension or robotic sacrocopexy ]
This is a binary outcome, and success is defined as answering "No" to question #3 on the Pelvic Organ Prolapse Distress Inventroy (PFDI-20) questionnaire, as well as the absence of any reoperation or pessary use for pelvic organ prolapsed.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Uterosacral Ligament Suspension vs Robotic Sacrocolpopexy
Official Title Long Term Outcomes of Uterosacral Ligament Suspension Versus Robotic Sacrocolpopexy
Brief Summary This cross sectional, two cohort study seeks to investigate both anatomic outcome and subjective, functional outcome of uterosacral ligament suspension versus robotic sacrocolpopexy and compare patient satisfaction, bladder function, sexual function and complication rate for each procedure.This study will provide a better understanding about the durability of these procedures and long term complication.
Detailed Description

Pelvic organ prolapse is a common problem affecting many women and there is a 12.6% lifetime risk of undergoing reconstructive pelvic surgery. There are several surgical options available to patients undergoing reconstruction for pelvic organ prolapse, however addressing the apex is recommended to achieve the most durable outcomes. Two of the most commonly performed procedures for apical prolapse repair are uterosacral ligament suspension and robotic sacrocolpopexy.

High uterosacral ligament suspension is a native tissue repair which is performed by affixing the vaginal apex to the bilateral uterosacral ligaments using permanent or delayed-absorbable sutures. This is performed typically in a vaginal approach. Sacrocolpopexy is a performed by attaching the anterior and posterior vaginal walls to the sacral promontory using synthetic mesh, typically polypropylene. This procedure can be performed by an abdominal approach, a laparoscopic approach or with the assistance of the da Vinci robotic system. In recent years, robotic sacrocolpopexy has largely replaced the abdominal approach, and become the procedure of choice for minimally invasive surgeons.

Most studies evaluating sacrocolpopexy outcomes were performed prior to the popularity of robotics and therefore concentrate on abdominal sacrocolpopexy.

This cross sectional, two cohort study will compare outcomes of uterosacral ligament suspension versus robotic sacrocolpopexy and will give pelvic surgeons a better understanding about the durability of these procedures, and possible longer term complication rates.

Subjects will be contacted and asked to come to the office for a visit and completion of questionnaires. If they cannot come to the office, an Informed Consent Form (ICF) and questionnaires will be mailed to them to complete and return separately.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All women 18 years of age or older who underwent the uterosacral ligament suspension or robotic sacrocolpopexy for treatment of pelvic organ prolapse 3-7 years ago.
Condition Pelvic Organ Prolapse
Intervention Not Provided
Study Groups/Cohorts
  • Uterosacral ligament suspension (USLS)
    This group of patients underwent the procedure of native tissue vaginal reconstructive surgery using uterosacral ligament suspension for pelvic organ prolapse.
  • Robotic sacrocolpopexy (RSC)
    This group of patients underwent the reconstructive pelvic surgery of robotic sacrocolpopexy using synthetic mesh.
Publications * Smith BC, Crisp CC, Kleeman SD, Yook E, Pauls RN. Uterosacral Ligament Suspension Versus Robotic Sacrocolpopexy for Treatment of Apical Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):93-98. doi: 10.1097/SPV.0000000000000704.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 19, 2017)
186
Original Estimated Enrollment
 (submitted: April 13, 2016)
246
Actual Study Completion Date October 16, 2018
Actual Primary Completion Date May 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women aged 18 years of age or older who spent 3-7 years following uterosacral ligament suspension or robotic sacrocolpopexy.
  • Concurrent procedures such as suburethral sling, bilateral salpingoophorectomy, hysterectomy, rectopexy.
  • Concurrent procedures such a s takedown of sling

Exclusion Criteria:

  • Concurrent procedure to remove vaginal mesh at time of their index surgery
  • Unwillingness to participate in the study
  • Dementia or inability to provide informed consent
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02741830
Other Study ID Numbers 16-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party TriHealth Inc.
Study Sponsor TriHealth Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Rachel Pauls, MD TriHealth - Cincinnati Urogynecology Associates
PRS Account TriHealth Inc.
Verification Date February 2018