Surgical Correction of Pelvic Organ Prolapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luigi Mearini, University Of Perugia
ClinicalTrials.gov Identifier:
NCT01182090
First received: August 12, 2010
Last updated: May 19, 2014
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Pelvic Organ Prolapse
Procedure: Colposacropexy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OPEN SURGERY VS LAPAROSCOPY IN SURGERY OF PELVIC ORGAN PROLAPSE

Resource links provided by NLM:


Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • Operative morbidity and adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Subjective and objective success rate, Patient satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Success rate: subjective success is absence of symptoms related to prolapse or incontinence using Urogenital Distress Inventory (URI-6) and Impact Incontinence Quality of Life (IIQ-7). Patient satisfaction is defined by replies to the questions of whether the patient is satisfied and would repeat the operation. Objective success is defined as no vaginal prolapse greater or equal to grade 2 at any vaginal site, while the patient performed Valsalva's manouever.


Enrollment: 40
Study Start Date: August 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prolapse repair by open approach
Correction of urogenital prolapse by open surgery approach
Procedure: Colposacropexy
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.
Other Name: colposacropexy
Active Comparator: Prolapse repair by laparoscopic approach
Correction of urogenital prolapse by laparoscopic approach
Procedure: Colposacropexy
In laparoscopic 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.
Other Name: colposacropexy

Detailed Description:

Surgical technique In both open or laparoscopic 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Study inclusion criteria were POP > 2, age ≥ 18 and ≤ 75 yrs.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01182090

Locations
Italy
Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology
Perugia, Italy, 06100
Sponsors and Collaborators
University Of Perugia
Investigators
Study Director: Massimo Porena, MD Prof in Chief Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology
  More Information

Additional Information:
Publications:
Responsible Party: Luigi Mearini, senior assistant, University Of Perugia
ClinicalTrials.gov Identifier: NCT01182090     History of Changes
Other Study ID Numbers: UPerugia
Study First Received: August 12, 2010
Last Updated: May 19, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by University Of Perugia:
pelvic organ prolapse
colposacropexy
surgery

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 01, 2014