Surgical Correction of Pelvic Organ Prolapse
Recruitment status was Recruiting
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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 |
- 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.
- 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.
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2011 (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 |
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| Contact: Elisabetta Costantini, MD | 0755784416 ext 0039 | ecostant@unipg.it |
| Italy | |
| Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology | Recruiting |
| Perugia, Italy, 06100 | |
| Contact: Elisabetta Costantini, MD 0755784416 ext 0039 ecostant@unipg.it | |
| Principal Investigator: Luigi Mearini, MD | |
| 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: | Massimo Porena, Professor in Chief, University of Perugia |
| ClinicalTrials.gov Identifier: | NCT01182090 History of Changes |
| Other Study ID Numbers: | UPerugia |
| Study First Received: | August 12, 2010 |
| Last Updated: | August 13, 2010 |
| 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 October 17, 2012
