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NCT01394237 Clinical Trial

Laparoscopic Sacrocolpopexy: Long Term Follow-up

Vaginal Vault Prolapse Clinical Trial

Official title:
Laparoscopic Sacrocolpopexy: Long Term Results With Special Focus on Anatomical Results and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01394237
Other study ID # SakPexFup
Secondary ID
Status Completed
Phase N/A
First received July 13, 2011
Last updated March 11, 2014
Start date June 2011
Est. completion date December 2011

Study information
Verified date March 2014
Source Kantonsspital Aarau
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine the long term results of laparoscopic sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries required, patients satisfaction and quality of life.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date December 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007

- consent

Exclusion Criteria:

- no consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Examination
Examination of recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system

Locations
Country Name City State
Switzerland Frauenklinik Kantonsspital Aarau Aarau Aargau

Sponsors (1)
Lead Sponsor Collaborator
Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Sarlos D, Brandner S, Kots L, Gygax N, Schaer G. Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Oct;19(10):1415-22. doi: 10.1007/s00192-008-0657-0. Epub 2008 Jun 7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrences according to pelvic organ prolapse quantification (POP-Q) assessment Recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system 3-6 years after surgery No
Secondary Quality of life Quality of life as assessed by a specific validated questionnaire 3-6 years after surgery No
See also
  Status Clinical Trial Phase
Completed NCT03681223 - Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy N/A
Completed NCT02290288 - Prospective Study for Vaginal Vault Prolapse After Hysterectomy: Comparison of Two Surgical Methods N/A
Active, not recruiting NCT03714607 - Laser Therapy in Managing Vaginal Prolapse N/A
Recruiting NCT04172896 - Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse N/A
Completed NCT01840176 - Prophylactic Modified McCall Culdoplasty During Total Laparoscopic Hysterectomy N/A
Active, not recruiting NCT01097200 - Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse N/A
Completed NCT00223106 - Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse N/A
Recruiting NCT05628831 - Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair N/A
Completed NCT02680145 - Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use N/A
Recruiting NCT00928239 - Laparoscopic Sacropexy: Comparison of Mesh Attachment N/A
Recruiting NCT05688059 - Absorbable Suture vs Permanent Suture in Sacrospinous Ligament Suspension N/A
Completed NCT01244165 - Study of Cytrix Use in Pelvic Floor Prolapse Treatment Phase 4
Completed NCT02431897 - Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen Phase 4
Completed NCT04038099 - Lessons on Urethral Lidocaine in Urodynamics Phase 4
Recruiting NCT05960292 - Laparoscopic Versus Vaginal Approach Closure Complications N/A
Recruiting NCT00886223 - Laparoscopic Sacropexy With Robot-Assisted Surgical System N/A