Surgical Correction of Pelvic Organ Prolapse

NCT01182090 | Completed Phase 3

• 1 other identifier: UPerugia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This prospective randomized trial evaluated outcomes of colposacropexy performed either by open or by conventional laparoscopic approach as therapy for uterovaginal prolapse. Surgical techniques, efficacy and overall results are compared. Methods: In this prospective study 40 consecutive patients with uro-genital prolapse are randomized to sacropexy: 20 by an open approach, 20 by a conventional laparoscopy approach. Anchorage is achieved in both groups by two polypropylene meshes. Check-ups were scheduled at 3, 6, 12 months and then yearly. Pre-operative patient characteristics, operative and post-operative events and follow-up results are recorded.

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse; colposacropexy; surgery

Outcome Measures

Primary Outcomes (1)

• Operative morbidity and adverse events

  Operative morbidity according to Clavien-Dindo classification, measure of perioperative pain with Visual Analogue Score VAS, post-operative adverse events constitute the outcome measures, together with operating time, intra-operative blood loss and length of hospital stay.

  2 years

Secondary Outcomes (1)

• Subjective and objective success rate, Patient satisfaction

  2 years

Study Arms (2)

Prolapse repair by open approach

ACTIVE COMPARATOR

Correction of urogenital prolapse by open surgery approach

Procedure: Colposacropexy

Prolapse repair by laparoscopic approach

ACTIVE COMPARATOR

Correction of urogenital prolapse by laparoscopic approach

Procedure: Colposacropexy

Interventions

Colposacropexy PROCEDURE

In open approach the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh will be attached with four-five Polyglycolic 0 sutures. The procedure is repeated for the posterior vaginal wall, where the mesh will be attached with three-four Polyglycolic 0 sutures. The sacral promontory surface is prepared and 1 or 2 non-reabsorbable 0.0 sutures are placed into the sacral periosteum about 2 cm below the promontory. A sub-peritoneal tunnel is created through which meshes are passed avoiding traction to the sacrum. The peritoneum is closed over the meshes.

Prolapse repair by open approach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Malignant uterus lesion (leiomyoma, fibromyoma, cervical or endometrial carcinoma)
• Active pelvic inflammatory disease,
• Known hypersensitivity to synthetic materials (polypropylene or polyglycolic acid)
• Pregnancy or lactation
• Evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases; and
• Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology

Perugia, 06100, Italy

Location

Related Publications (3)

• Costantini E, Mearini L, Bini V, Zucchi A, Mearini E, Porena M. Uterus preservation in surgical correction of urogenital prolapse. Eur Urol. 2005 Oct;48(4):642-9. doi: 10.1016/j.eururo.2005.04.022.

  PMID: 15964131 BACKGROUND

• Costantini E, Zucchi A, Giannantoni A, Mearini L, Bini V, Porena M. Must colposuspension be associated with sacropexy to prevent postoperative urinary incontinence? Eur Urol. 2007 Mar;51(3):788-94. doi: 10.1016/j.eururo.2006.08.034. Epub 2006 Sep 5.

  PMID: 17011699 BACKGROUND

• Costantini E, Lazzeri M, Bini V, Del Zingaro M, Zucchi A, Porena M. Burch colposuspension does not provide any additional benefit to pelvic organ prolapse repair in patients with urinary incontinence: a randomized surgical trial. J Urol. 2008 Sep;180(3):1007-12. doi: 10.1016/j.juro.2008.05.023. Epub 2008 Jul 17.

  PMID: 18639302 BACKGROUND

Related Links

• university of perugia

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Porena, MD Prof in Chief

  Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior assistant

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 16, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 20, 2014

Record last verified: 2010-07

Locations

IT (1)