Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse
This study is currently recruiting participants.
Verified March 2012 by Hospital Clinic of Barcelona
Sponsor:
Francisco Carmona
Collaborator:
American Medical Systems
Information provided by (Responsible Party):
Francisco Carmona, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01097200
First received: March 30, 2010
Last updated: March 22, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. New meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published.
The investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.
| Condition | Intervention |
|---|---|
|
Vaginal Vault Prolapse Enterocele Uterine Prolapse Cystocele Rectocele |
Device: Elevate mesh Device: Sacrocolpopexy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Anatomic and Functional Outcomes of Vaginal Mesh ( ELEVATE) Compared With Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse |
Resource links provided by NLM:
Further study details as provided by Hospital Clinic of Barcelona:
Primary Outcome Measures:
- Functional and anatomical efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- operating time, cost and complications of both techniques [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Elevate meshes
The use of Elevate (American Systems trade mark) meshes for the treatment of pelvic prolapse.
|
Device: Elevate mesh
The correction of the prolapse can be made by this new technique.
Other Name: Pelvic meshes
|
|
Sacrocolpopexy
Sacrocolpopexy for the correction of the prolapse
|
Device: Sacrocolpopexy
Attach a mesh between the vagina and the promontorium.
Other Name: Colpofixation
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has been diagnosed with one or more clinically significant anterior, apical, or posterior genital prolapse disorder(s)(symptomatic POP-Q stage II or higher) requiring surgical repair.
Exclusion Criteria:
- Investigator determines subject is not a candidate for surgical repair of her genital prolapse.
- Subject has had a prior prolapse procedure involving graft placement (synthetic or biologic)
- Subject has active or latent systemic infection or signs of tissue necrosis.
- Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement / prosthesis.
- Subject is currently pregnant or intends to become pregnant during the study period.
- Subject has had radiation therapy to the pelvic area.
- Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
- Subject has uncontrolled diabetes.
- Subject is on any medication with could result in compromised immune response, such as immune modulators.
- Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study.
- Subject is unwilling or unable to give valid informed consent.
- Subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of Life questionnaires and return for all follow-up visits.
- Subject with contraindications for laparoscopy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097200
Contacts
| Contact: Eduardo Bataller, M.D , PH. D. | 34932275436 | ebatalle@clinic.ub.es |
| Contact: Eduardo Bataller, M.D.; PH. D. | 34932275436 | ebatalle@clinic.ub.es |
Locations
| Spain | |
| Hospital Clinic Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Sub-Investigator: Francisco Carmona, M.D, Ph. D. | |
| Sub-Investigator: Montse Espuña, M.D., Ph. D. | |
| Sub-Investigator: Montse Puig, M.D. | |
| Sub-Investigator: Jordi Deu, M.D. | |
Sponsors and Collaborators
Francisco Carmona
American Medical Systems
Investigators
| Principal Investigator: | Eduardo Bataller, M.D., Ph. D. | Hospital Clinic, Barcelona, Spain. |
More Information
Publications:
Cosson M, Rosenthal C, Clave H, et al. Prospective clinical assessment of the total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse-6 and 12 month results. Int Urogynecol J 2006; 17: S142.
| Responsible Party: | Francisco Carmona, Chief of Department of OB GYN, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT01097200 History of Changes |
| Other Study ID Numbers: | Bataller01 |
| Study First Received: | March 30, 2010 |
| Last Updated: | March 22, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Hospital Clinic of Barcelona:
|
sacrocolpopexy meshes sacrospinous ligament |
Additional relevant MeSH terms:
|
Cystocele Prolapse Uterine Prolapse Rectocele Hernia Pelvic Organ Prolapse Urinary Bladder Diseases Urologic Diseases |
Pathological Conditions, Anatomical Uterine Diseases Genital Diseases, Female Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013