Laparoscopic Sacrocolpopexy: Long Term Follow-up

• Sponsor: Kantonsspital Aarau (Other)
• Overall Status: Completed
• CT.gov ID: NCT01394237
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 12.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Vault Prolapse	Other: Examination

Study Design

• Study Type: Observational
• Actual Enrollment: 75 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Laparoscopic Sacrocolpopexy: Long Term Results With Special Focus on Anatomical Results and Quality of Life
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Operated by laparoscopic sacrocolpopexy Patients operated at our institution by laparoscopic sacrocolpopexy between 2003 and 2007	Other: Examination; Examination of recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system; Other Names: exam test assessment

Outcome Measures

Primary Outcome Measures

1. Recurrences according to pelvic organ prolapse quantification (POP-Q) assessment [3-6 years after surgery]

   Recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system

Secondary Outcome Measures

1. Quality of life [3-6 years after surgery]

   Quality of life as assessed by a specific validated questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• consent

Exclusion Criteria:

• no consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Frauenklinik Kantonsspital Aarau	Aarau	Aargau	Switzerland	5001

Sponsors and Collaborators

• Kantonsspital Aarau

Investigators

• Study Director: Dimitri Sarlos, MD, Kantonsspital Aarau

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Dimitri Sarlos, Head Gynaecology and oncological Gynaecology, Kantonsspital Aarau
• ClinicalTrials.gov Identifier: NCT01394237
• Other Study ID Numbers: SakPexFup
• First Posted: Jul 14, 2011
• Last Update Posted: Mar 12, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Mar 12, 2014