Clinical trial NCT01182090: Surgical Correction of Pelvic Organ Prolapse
Official title: OPEN SURGERY VS LAPAROSCOPY IN SURGERY OF PELVIC ORGAN PROLAPSE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
colposacropexy
surgery
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2010-08-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Operative morbidity and adverse events
timeFrame: 2 years
Secondary outcomes:
measure: Subjective and objective success rate, Patient satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology
Study officials:
affiliation: Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology
name: Massimo Porena, MD Prof in Chief
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/j.eururo.2005.04.022.
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. doi: 10.1016/j.eururo.2006.08.034. Epub 2006 Sep 5.
citation: 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.