Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy

Study Overview
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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.

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.

Official Title
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Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy: a Randomized Controlled Trial

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Polyglactin 910 or polydioxanone
* Device: Polyester or polypropylene


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Absorbable suture<br>will undergo anterior colporrhaphy in a traditional manner using either 2-0 polyglactin 910 [Vicryl] or polydioxanone [PDS II] sutures. | Device: Polyglactin 910 or polydioxanone<br>* Vicryl or PDS II<br>|
| Experimental: Nonabsorbable suture<br>will undergo anterior colporrhaphy in a traditional manner using either 2-0 polyester [Ethibond Excel] or polypropylene [Prolene] sutures. | Device: Polyester or polypropylene<br>* Ethibond Excel or prolene<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical success | defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen (POPQ point Ba>0); (2) presence of vaginal bulge symptoms (affirmative response to the question 3 from the Pelvic Floor Distress Inventory-20 (do you usually have a bulge or something falling out that you can see or feel in your vaginal area?; (3) re-treatment for recurrent anterior vaginal wall prolapse by either surgery or pessary. | One year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of anterior vaginal descent beyond the hymen | POPQ point Ba>0 | One year after surgery | 
| The rate of vaginal bulge symptoms | an affirmative response to the question 3 from PFDI-20 | One year after surgery | 
| The rate of re-treatment for recurrent anterior vaginal wall prolapse | by either surgery or pessary | One year after surgery | 
| The rate of suboptimal anatomical outcome in each compartment | POPQ point Ba, C, or Bp ≥-1 | One year after surgery | 
| Change of POPQ values | point Ba, C, Bp and TVL | From baseline to 1 year after surgery | 
| Change of PFDI-20 scores | The PFDI-20 is a valid and reliable condition-specific quality-of-life questionnaires for women with pelvic floor disorders. It has 20 items and 3 scales (Pelvic Organ Prolapse Distress Inventory, Colorectal-Anal Distress Inventory and Urinary Distress Inventory). Each scale is scored from 0 to 100; higher scores indicate greater symptom burden. The PFDI-20 total score is obtained by adding the scores from the 3 scale scores together (0-300). | From baseline to 1 year after surgery | 
| The rate of adverse events related with anterior colporrhaphy | intraoperative- bladder injury, ureteral obstruction, massive bleeding postoperative- hematoma, vesico-vaginal fistula, ureteral obstruction, urinary tract infection, incomplete bladder emptying, overactive bladder or stress incontinence symptoms, suture erosion, vaginal wound dehiscence, infection or granulation tissue, etc. | From baseline to 1 year after surgery |