Pelvic Organ Prolapse
Conditions
Brief summary
The objective of this is to compare surgical outcomes of anterior colporrhaphy using nonabsorbable sutures with anterior colporrhaphy using absorbable sutures.
Detailed 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.
Interventions
DEVICEPolyglactin 910 or polydioxanone
Vicryl or PDS II
DEVICEPolyester or polypropylene
Ethibond Excel or prolene
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical success | One year after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of vaginal bulge symptoms | One year after surgery | an affirmative response to the question 3 from PFDI-20 |
| The rate of re-treatment for recurrent anterior vaginal wall prolapse | One year after surgery | by either surgery or pessary |
| The rate of suboptimal anatomical outcome in each compartment | One year after surgery | POPQ point Ba, C, or Bp ≥-1 |
| The rate of anterior vaginal descent beyond the hymen | One year after surgery | POPQ point Ba\>0 |
| Change of PFDI-20 scores | From baseline to 1 year after surgery | 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). |
| The rate of adverse events related with anterior colporrhaphy | From baseline to 1 year after surgery | 1. intraoperative- bladder injury, ureteral obstruction, massive bleeding 2. 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. |
| Change of POPQ values | From baseline to 1 year after surgery | point Ba, C, Bp and TVL |
Countries
South Korea
Outcome results
None listed