Anterior Elevate or Laparoscopic Abdominal Sacrocolpopexy in women with post hysterectomy apical prolapse – a Randomised Controlled Trial

Not Applicable

Recruiting

• Conditions: post hysterectomy vaginal vault prolapse; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12611001111965
• Lead Sponsor: Anna Rosamilia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 116

Inclusion Criteria

1.patients with symptomatic post hysterectomy Apical Prolapse greater or equal to Stage 2 (point C greater than or equal to -1) referred for surgery
2.Willing to participate and return for follow up
3.able to provide informed consent

Exclusion Criteria

1.Unable to undergo GA
2.Unable to understand questionnaires, give informed consent or return for review
3.BMI >35
4. more than or equal to 5 laparotomies
5. Previous synthetic mesh used for POP
6. Previous sacro colpopexy
7. total vaginal length < 6cm
8. chronic pelvic pain
9. Genito urinary anomaly (congenital)
10.Neurogenic bladder disorders
11.Previous radiation therapy to pelvis
12.Past history of any form of fistula involving the vagina
13.Allergy to polypropylene or local anaesthetic

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of apical prolapse greater or equal to stage 2 (Point C below -1cm)[12 months & 36 months]

Secondary Outcome Measures

Name	Time	Method
Incidence of overall prolapse greater or equal to stage 2[12 months & 36 months];subjective prolapse symptom score using PFDI-20[12 months & 36 months];(prolapse) symptom impact using PFIQ 7[12 months & 36 months];global impression of improvement using PGI-I[12 months & 36 months];sexual function using PISQ 12[12 months & 36 months]