Clinical trial NCT03736811: Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy
Official title: Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 196
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical success
timeFrame: One year after surgery
Secondary outcomes:
measure: The rate of anterior vaginal descent beyond the hymen
timeFrame: One year after surgery
measure: The rate of vaginal bulge symptoms
timeFrame: One year after surgery
measure: The rate of re-treatment for recurrent anterior vaginal wall prolapse
timeFrame: One year after surgery
measure: The rate of suboptimal anatomical outcome in each compartment
timeFrame: One year after surgery
measure: Change of POPQ values
timeFrame: From baseline to 1 year after surgery
measure: Change of PFDI-20 scores
timeFrame: From baseline to 1 year after surgery
measure: The rate of adverse events related with anterior colporrhaphy
timeFrame: From baseline to 1 year after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Myung Jae, Jeon
Study officials:
affiliation: Seoul National University Hospital
name: Myung Jae Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.