Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy

Seoul National University

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Device: Polyester or polypropylene; Device: Polyglactin 910 or polydioxanone

Study type: Interventional

Funder types: Other

Identifiers

NCT03736811

SNUH-1810-037-977

Details and patient eligibility

About

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

Full description

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.

Enrollment: 196 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 2 patient groups

Absorbable suture

Active Comparator group

Description:

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

Treatment:

Device: Polyglactin 910 or polydioxanone

Nonabsorbable suture

Experimental group

Description:

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

Treatment:

Device: Polyester or polypropylene