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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absorbable suture | Active Comparator | will undergo anterior colporrhaphy in a traditional manner using either 2-0 polyglactin 910 [Vicryl] or polydioxanone [PDS II] sutures. |
|
| Nonabsorbable suture | Experimental | will undergo anterior colporrhaphy in a traditional manner using either 2-0 polyester [Ethibond Excel] or polypropylene [Prolene] sutures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyglactin 910 or polydioxanone | Device | Vicryl or PDS II |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myung Jae Jeon, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Myung Jae, Jeon | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32554735 | Derived | Jeon MJ, Suh DH, Kim CH, Cho HH, Shin JH, Lee SR, Jung YW, Kim SR, Kong MK. Non-absorbable versus absorbable sutures for anterior colporrhaphy: study protocol for a randomised controlled trial in South Korea. BMJ Open. 2020 Jun 16;10(6):e034218. doi: 10.1136/bmjopen-2019-034218. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Polyester or polypropylene |
| Device |
Ethibond Excel or prolene |
|
| 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 |
| From baseline to 1 year after surgery |