Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy

NCT03736811 | Unknown

• 1 other identifier: SNUH-1810-037-977
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The rate of anterior vaginal descent beyond the hymen

  One year after surgery

• The rate of vaginal bulge symptoms

  One year after surgery

• The rate of re-treatment for recurrent anterior vaginal wall prolapse

  One year after surgery

• The rate of suboptimal anatomical outcome in each compartment

  One year after surgery

• Change of POPQ values

  From baseline to 1 year after surgery

Study Arms (2)

Absorbable suture

ACTIVE COMPARATOR

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

Nonabsorbable suture

EXPERIMENTAL

will undergo anterior colporrhaphy in a traditional manner using either 2-0 polyester \[Ethibond Excel\] or polypropylene \[Prolene\] sutures.

Device: Polyester or polypropylene

Interventions

Polyglactin 910 or polydioxanone DEVICE

Vicryl or PDS II

Absorbable suture

Polyester or polypropylene DEVICE

Ethibond Excel or prolene

Nonabsorbable suture

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Myung Jae, Jeon

Seoul, 03080, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32554735 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Myung Jae Jeon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 9, 2018
• Study Start: November 8, 2018
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)