Back to results

Surgical Correction of Pelvic Organ Prolapse

Primary Purpose

Pelvic Organ Prolapse

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Colposacropexy

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, colposacropexy, surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Prolapse repair by open approach

Prolapse repair by laparoscopic approach

Arm Description

Correction of urogenital prolapse by open surgery approach

Correction of urogenital prolapse by laparoscopic approach

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01182090

First Posted

August 12, 2010

Last Updated

May 19, 2014

Sponsor

University Of Perugia

1. Study Identification

Unique Protocol Identification Number

NCT01182090

Brief Title

Surgical Correction of Pelvic Organ Prolapse

Official Title

OPEN SURGERY VS LAPAROSCOPY IN SURGERY OF PELVIC ORGAN PROLAPSE

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Of Perugia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse, colposacropexy, surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prolapse repair by open approach

Arm Type

Active Comparator

Arm Description

Correction of urogenital prolapse by open surgery approach

Arm Title

Prolapse repair by laparoscopic approach

Arm Type

Active Comparator

Arm Description

Correction of urogenital prolapse by laparoscopic approach

Intervention Type

Procedure

Intervention Name(s)

Colposacropexy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Colposacropexy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Operative morbidity and adverse events

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Subjective and objective success rate, Patient satisfaction

Description

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Massimo Porena, MD Prof in Chief

Organizational Affiliation

Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology

Official's Role

Study Director

Facility Information:

Facility Name

Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology

City

Perugia

ZIP/Postal Code

06100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

15964131

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.

Results Reference

background

PubMed Identifier

17011699

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.

Results Reference

background

PubMed Identifier

18639302

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.

Results Reference

background

Links:

URL

http://www.unipg.it

Description

university of perugia

Learn more about this trial

Surgical Correction of Pelvic Organ Prolapse

We'll reach out to this number within 24 hrs