Pelvic Organ ProlapseNCT03736811
Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy
A study testing Polyglactin 910 or polydioxanone and Polyester or polypropylene in people with Pelvic Organ Prolapse, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The objective of this is to compare surgical outcomes of anterior colporrhaphy using nonabsorbable sutures with anterior colporrhaphy using absorbable sutures. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Polyglactin 910 or polydioxanone and Polyester or polypropylene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Nov 2018to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Polyglactin 910 or polydioxanone, Polyester or polypropylene
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglactin 910 or polydioxanoneDevice
Vicryl or PDS II
Polyester or polypropyleneDevice
Ethibond Excel or prolene
| Study group | Role | What they receive |
|---|---|---|
| Absorbable suture | Active comparator | will undergo anterior colporrhaphy in a traditional manner using either 2-0 polyglactin 910 [Vicryl] or polydioxanone [PDS II] sutures. Receives: 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. Receives: Device: Polyester or polypropylene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year after surgery
Secondary outcomes (7)
The rate of anterior vaginal descent beyond the hymen
POPQ point Ba>0
Measured: One year after surgery
The rate of vaginal bulge symptoms
an affirmative response to the question 3 from PFDI-20
Measured: One year after surgery
The rate of re-treatment for recurrent anterior vaginal wall prolapse
by either surgery or pessary
Measured: One year after surgery
The rate of suboptimal anatomical outcome in each compartment
POPQ point Ba, C, or Bp ≥-1
Measured: One year after surgery
Change of POPQ values
point Ba, C, Bp and TVL
Measured: 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).
Measured: 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.
Measured: From baseline to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start8 Nov 2018
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung Jae Jeon, Seoul National University Hospital
- Investigators
- Myung Jae Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736811
- Sponsor's protocol ID
- SNUH-1810-037-977
- Status last verified
- May 2022
- First submitted
- 8 Nov 2018
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32554735
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03736811
- Acronym / sponsor ID
- SNUH-1810-037-977
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable suture | Active comparator | Device: Polyglactin 910 or polydioxanonewill undergo anterior colporrhaphy in a traditional manner using either 2-0 polyglactin 910 [Vicryl] or polydioxanone [PDS II] sutures. |
| Nonabsorbable suture | Experimental | Device: Polyester or polypropylenewill undergo anterior colporrhaphy in a traditional manner using either 2-0 polyester [Ethibond Excel] or polypropylene [Prolene] sutures. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyglactin 910 or polydioxanoneVicryl or PDS II | Device | Absorbable suture |
| Polyester or polypropyleneEthibond Excel or prolene | Device | Nonabsorbable suture |
Primary outcome
Surgical success
Time frame: 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.
7 secondary outcomes
The rate of anterior vaginal descent beyond the hymen
Time frame: One year after surgery
The rate of vaginal bulge symptoms
Time frame: One year after surgery
The rate of re-treatment for recurrent anterior vaginal wall prolapse
Time frame: One year after surgery
The rate of suboptimal anatomical outcome in each compartment
Time frame: One year after surgery
Change of POPQ values
Time frame: From baseline to 1 year after surgery
Change of PFDI-20 scores
Time frame: From baseline to 1 year after surgery
The rate of adverse events related with anterior colporrhaphy
Time frame: From baseline to 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 32554735Jeon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myung Jae Jeon, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyglactin 910 or polydioxanone and Polyester or polypropylene in people with Pelvic Organ Prolapse, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success (time frame: One year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.