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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611001111965
• Date of registration: 25/10/2011
• Prospective Registration: Yes
• Primary sponsor: Anna Rosamilia
• Public title: Anterior Elevate or Laparoscopic Abdominal Sacrocolpopexy in women with post hysterectomy apical prolapse – a Randomised Controlled Trial
• Scientific title: In patients with post hysterectomy prolapse, is Anterior Elevate mesh kit as good as or better than Laparoscopic Sacrocolpopexy for prolapse recurrence
• Date of first enrolment: 01/12/2011
• Target sample size: 116
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12611001111965.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Joseph Lee

• Name: Alison Leitch

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Females

Health Condition(s) or Problem(s) studied

post hysterectomy vaginal vault prolapse;
post hysterectomy vaginal vault prolapse

Renal and Urogenital - Other renal and urogenital disorders

Intervention(s)

Anterior Elevate mesh kit

to provide support, a synthetic monofilament polypropylene mesh (permanent) is placed under the bladder and top of vagina, via a vagina incision in this operation that could take up to 1.5 hours

Primary Outcome(s)

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

Secondary Outcome(s)

Incidence of overall prolapse greater or equal to stage 2[12 months & 36 months]

sexual function using PISQ 12[12 months & 36 months]

subjective prolapse symptom score using PFDI-20[12 months & 36 months]

global impression of improvement using PGI-I[12 months & 36 months]

(prolapse) symptom impact using PFIQ 7[12 months & 36 months]

Secondary ID(s)

Nil

Secondary Sponsor(s)

Joseph Lee

Ethics review

Status: Approved
Approval date:
Contact:

Southern Health HREC