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

In patients with post hysterectomy prolapse, is Anterior Elevate mesh kit as good as or better than Laparoscopic Sacrocolpopexy for prolapse recurrence

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001111965
Acronym
AELAS
Enrollment
116
Registered
2011-10-25
Start date
2011-12-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Female pelvic organ prolapse, which is a protrusion of vaginal walls beyond the hymen, is both common and have a high burden of suffering. The traditional operation to treat post hysterectomy vaginal apical prolapse has been either abdominal sacrocolpopexy or vaginal sacrospinous fixation. Although the abdominal approach comes with a greater cure rate, it has a longer operating time, longer return to Activities of Daily Living and costs more than the vaginal approach. Modern advances involve the development of minimally invasive procedures which included a laparoscopic approach to abdominal sacrocolpopexy and also the introduction of vaginal mesh kits which provides better success rates when compared to the traditional vaginal operation, although not without its own sets of operative morbidity. These procedures involve inserting synthetic material anchored to the sacrospinous ligament to provide reinforcement and support to the vagina following its repair. Anterior Elevate is a new mesh kit which utilises a standard synthetic mesh using a surgical approach (anterior sacrospinous) that has been well established since 2001. The purpose of this project is to evaluate the success of Anterior Elevate vaginal mesh support or laparoscopic sacrocolpopexy in the treatment of women with vaginal apical prolapse.

Interventions

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

Sponsors

Anna Rosamilia
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026