Surgical Correction of Pelvic Organ Prolapse

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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OPEN SURGERY VS LAPAROSCOPY IN SURGERY OF PELVIC ORGAN PROLAPSE

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Colposacropexy
* Procedure: Colposacropexy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prolapse repair by open approach<br>Correction of urogenital prolapse by open surgery approach | Procedure: Colposacropexy<br>* 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.<br>|
| Active Comparator: Prolapse repair by laparoscopic approach<br>Correction of urogenital prolapse by laparoscopic approach | Procedure: Colposacropexy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective and objective success rate, Patient satisfaction | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic organ prolapse, colposacropexy, surgery