Surgical Correction of Pelvic Organ Prolapse
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | August 12, 2010 | ||||
| Last Updated Date | August 13, 2010 | ||||
| Start Date ICMJE | August 2010 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01182090 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Surgical Correction of Pelvic Organ Prolapse | ||||
| Official Title ICMJE | OPEN SURGERY VS LAPAROSCOPY IN SURGERY OF PELVIC ORGAN PROLAPSE | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Pelvic Organ Prolapse | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01182090 | ||||
| Other Study ID Numbers ICMJE | UPerugia | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Massimo Porena, Professor in Chief, University of Perugia | ||||
| Study Sponsor ICMJE | University Of Perugia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Of Perugia | ||||
| Verification Date | July 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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