Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: Polyglactin 910 or polydioxanone; Device: Polyester or polypropylene

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.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Myung Jae, Jeon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Absorbable suture; 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; Vicryl or PDS II
EXPERIMENTAL: Nonabsorbable suture; will undergo anterior colporrhaphy in a traditional manner using either 2-0 polyester [Ethibond Excel] or polypropylene [Prolene] sutures.	Device: Polyester or polypropylene; Ethibond Excel or prolene

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 8, 2018
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (ACTUAL): November 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: SNUH-1810-037-977

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No