Surgical Correction of Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

OPEN SURGERY VS LAPAROSCOPY IN SURGERY OF PELVIC ORGAN PROLAPSE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01182090
• Other study ID #: UPerugia
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2010
• Last updated: May 19, 2014
• Start date: August 2010
• Est. completion date: September 2012

Study information

• Verified date: July 2010
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Epub 2006 Sep 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   university of perugia