Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2023-06-30

Brief Summary

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The objective of this is to compare surgical outcomes of anterior colporrhaphy using nonabsorbable sutures with anterior colporrhaphy using absorbable sutures.

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Detailed Description

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This trial is a prospective, randomized trial conducted with the aim to determine superiority of anterior colporrhaphy using nonabsorbable sutures over absorbable sutures with regard to the primary outcome. Participants will undergo reconstructive surgery for prolapse, including anterior colporrhaphy using the assigned suture materials under general or spinal anesthesia. The anterior colporrhaphy will be performed in a traditional manner with midline plication of the fibromuscular layer using either 2-0 nonabsorbable (polyester or polypropylene; Ethicon, Somerville, NJ) or absorbable (polyglactin 910 or polydioxanone; Ethicon) sutures. Concomitant procedures will be performed as intended prior to surgery. Women with a uterus in situ will undergo hysterectomy and all women will receive an apical suspension procedure, including uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeal suspension, according to the preference of surgeon. Posterior colporrhaphy and incontinence surgery will also be performed, if indicated (i.e. women with Bp ≥-1 or documented urodynamic stress incontinence).

Enrollment, treatment and data collection will be standardized by all sites. The study will be a single-blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject in assigned. However, all outcomes assessors and the subjects will be blinded to the treatment assignment. Postoperative follow-up will take place after 5 weeks, 6 months and 12 months. Patients will undergo a standard gynecological examination including POPQ and fill in questionnaires.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Absorbable suture

will undergo anterior colporrhaphy in a traditional manner using either 2-0 polyglactin 910 \[Vicryl\] or polydioxanone \[PDS II\] sutures.

Group Type ACTIVE_COMPARATOR

Polyglactin 910 or polydioxanone

Intervention Type DEVICE

Vicryl or PDS II

Nonabsorbable suture

will undergo anterior colporrhaphy in a traditional manner using either 2-0 polyester \[Ethibond Excel\] or polypropylene \[Prolene\] sutures.

Group Type EXPERIMENTAL

Polyester or polypropylene

Intervention Type DEVICE

Ethibond Excel or prolene

Interventions

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Polyglactin 910 or polydioxanone

Vicryl or PDS II

Intervention Type DEVICE

Polyester or polypropylene

Ethibond Excel or prolene

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Anterior vaginal descent beyond the hymen (i.e. POPQ Ba\>0)
* Vaginal bulge symptoms (i.e. an affirmative response to the question 3 from the PFDI-20)
* Reconstructive surgery is planned

Exclusion Criteria

* Recurrent anterior vaginal wall prolapse
* Reconstructive surgery using mesh or obliterative surgery for prolapse is planned
* Known pelvic malignancy
* Systemic glucocorticoid or immunosuppressant treatment
* Subject wishes to retain her uterus
* Subject is unable and unwilling to participate in

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No