RectoceleNCT04658784
Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy
A study testing 2-0 dioxanone, glycolide and trimethylene carbonate and 2-0 polydioxanone in people with Rectocele, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The aim of this randomized clinical trial is to compare barbed suture versus non-barbed suture at the time of posterior repair on postoperative pain scores as measured by a visual analog scale (VAS) at 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectocele
- What is being tested?
- 2-0 dioxanone, glycolide and trimethylene carbonate and 2-0 polydioxanone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Age 18yo or older
- English speaking
- Planned posterior colporrhaphy with or without perineorrhaphy with concomitant surgical procedures allowed
Who cannot join
- Documented allergy or contraindication to use of suture material
- Prior mesh in posterior compartment
- Planned colpocleisis
- Current or prior rectovaginal fistula
- Planned sacrospinous ligament fixation procedure
- Chronic pelvic pain diagnosis
Show all 11Show fewer
- Chronic narcotic medication use
- Active vulvodynia
- Non-English speaking
- Inability to provide informed consent
- Planned combined colorectal/anorectal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy: A Randomized Controlled Trial
The aim of this randomized clinical trial is to compare barbed suture versus non-barbed suture at the time of posterior repair on postoperative pain scores as measured by a visual analog scale (VAS) at 6 weeks.
Study participants are randomized to use of barbed suture (2-0 V-Loc 90TM, Medtronic) or non-barbed suture (2-0 Polydioxanone, PDS® EthiconTM) in a standardized technique for posterior colporrhaphy at the time of posterior repair.
Read the detailed description
Pelvic organ prolapse (POP) is a growing concern for the aging female population, and symptomatic women often require surgical intervention. Approximately 200,000 surgical procedures for POP are performed annually in the United States. This number is anticipated to increase with the growth in the aging population.1 Surgical prolapse repairs are often categorized into either mesh augmented or native tissue repairs. During a native tissue repair, the surgeon uses a woman's natural tissue to repair the prolapse without augmenting the repair with synthetic mesh.
Women often have post-operative pain with native tissue posterior colporrhaphy. Native tissue posterior repairs are performed to address symptomatic posterior compartment prolapse, defects in the rectovaginal fibromuscularis, and/or a widened genital hiatus. This type of repair may improve obstructed defecatory dysfunction and bulge symptoms, but can be associated with postoperative pelvic pain and dyspareunia. Paraiso et al evaluated three surgical techniques for posterior colporrhaphy (site-specific, midline plication, and porcine graft) and found no difference in overall symptom improvement, quality of life, and post-operative sexual function. Regardless of the technique used, a posterior colporrhaphy can cause considerable postoperative pain and can contribute to de novo dyspareunia in 9-20% of women. Most studies evaluating pain after posterior colporrhaphy tend to focus on various methods of analgesia and surgical technique rather than the suture materials used.
Suture choice may contribute to postoperative pain at the time of posterior colporrhaphy. There are few studies evaluating suture in the posterior compartment with no defined standard suture material for posterior colporrhaphy. Available studies, when comparing subjective bulge and quality of life outcomes, do not demonstrate superiority of one suture type over the other. Delayed absorbable suture has the benefit of retaining tensile strength for approximately 3 months. Delayed absorbable suture material itself, however, can remain in place for up to 8 months. These properties may decrease postoperative pain by decreasing knot burden. Barbed suture has been successfully applied to vaginal cuff closure, myomectomy, sacrocolpopexy mesh attachment, and closure of bowel and bladder injuries with demonstrated reduced operative times. To date, no studies have evaluated the impact of barbed suture on postoperative pain or surgical time after posterior colporrhaphy.
The primary objective for this study is to compare delayed absorbable barbed suture versus non-barbed delayed absorbable suture at the time of posterior repair on post-operative posterior compartment pain scores, as measured by the Visual Analog Scale (VAS), at 6 weeks
Secondary objectives include a comparison of VAS pain scores in the posterior compartment at 6-months, evaluation of operative time for posterior repair in minutes, evaluation of suture burden and pelvic pain on examination of the posterior compartment, evaluation of pain versus the length of a repair, evaluation of postoperative patient quality of life (QoL) using series of standardized questionnaires, evaluation of suture cost, and a comparison of anatomical and surgical failure in the posterior compartment.
Participants will be approached for participation preoperatively. Baseline demographic data will be abstracted from the medical record. A baseline Pelvic Organ Prolapse Quantification (POP-Q) and pelvic myofascial exam will be performed. Baseline VAS and validated questionnaires: Pelvic Floor Distress Inventory-20 (PFDI-20) sub-scales Colorectal-Anal Distress Inventory-8 (CRADI-8) and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire- 12 (PISQ-12 )will be completed. Participants will be randomized in the operating room after posterior vaginal dissection to either barbed or non-barbed suture in a standardized technique. All concurrent minimally invasive pelvic reconstructive surgical procedures are allowed. Randomization will be stratified for minimally invasive (robotic or laparoscopic) versus vaginal surgery.
Perioperative care is standardized.
Participants will be scheduled for a post-operative follow up visit at approximately 6 weeks. At this visit they will have a structured postoperative interview and pelvic examination, including POP-Q, standardized assessment of suture burden and myofascial trigger points. They will also complete a VAS and validated questionnaires. Participants will be called at approximately 6 months after their original surgery. They will have a structured interview and complete VAS and complete validated questionnaires.
Adverse postoperative outcomes will be collected at each visit.
Investigators will use a standard deviation estimate of 23.4mm to detect a difference on a 100mm VAS for pain. Accounting for a 15% drop-out rate, the investigators aim to enroll 64 participants with 32 in each group.
- Conditions
- Rectocele
- Being tested
- 2-0 dioxanone, glycolide and trimethylene carbonate, 2-0 polydioxanone
- Keywords
- pelvic organ prolapse, barbed suture, posterior colporrhaphy, posterior repair, pain
- Medical subject headings
- Rectocele, Pelvic Organ Prolapse, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-0 dioxanone, glycolide and trimethylene carbonateDevice
Also called 2-0 V-Loc 90TM (Medtronic)
delayed absorbable, monofilament barbed suture
2-0 polydioxanoneDevice
Also called 2-0 PDS® (Ethicon)
delayed absorbable, monofilament non-barbed suture
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic Receives: Device: 2-0 dioxanone, glycolide and trimethylene carbonate |
| Control | Active comparator | Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon Receives: Device: 2-0 polydioxanone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Posterior Compartment Pain Scores - Posterior Repair
To compare delayed absorbable barbed suture versus non-barbed delayed absorbable suture at the time of posterior repair on post-operative posterior compartment pain scores, as measured by the Visual Analog Scale (VAS).The VAS is a validated scale that is ranges from 0-100mm. 0mm is equivalent to "no pain" and is located on the left. 100mm is equivalent to "worst possible pain" and is located on the right. Reported as categorical variable no pain (VAS 0), low pain (VAS 1-33), moderate pain (VAS 34-66), and high pain (VAS 67-100).
Measured: Week 6
Secondary outcomes (10)
Post-operative Posterior Compartment Pain Scores
To compare visual analog scale (VAS) pain scores in the posterior compartment. The VAS is a validated scale that is ranges from 0-100mm. 0mm is equivalent to "no pain" and is located on the left. 100mm is equivalent to "worst possible pain" and is located on the right. Reported as categorical variable no pain, low pain, moderate pain and high pain. Reported as categorical variable no pain (VAS 0), low pain (VAS 1-33), moderate pain (VAS 34-66), and high pain (VAS 67-100).
Measured: Month 6
Operative Time
To evaluate operative time for posterior repair in minutes.
Measured: Time of Surgery
Suture Burden
To evaluate amount of suture burden present at time of surgery in posterior by compartment by measuring total amount of delayed absorbable suture used for posterior colporrhaphy in centimeters.
Measured: At time of surgery (Intraoperative)
Change in Bowel Function Scores
To evaluate change in bowel function using the Pelvic Floor Distress Inventory- 20 (PFDI-20) sub-scale Colorectal-Anal Distress Inventory-8 (CRADI-8). Total score (range 0 to 100) with the higher the score the more distress.
Measured: Baseline, Week 6, and month 6
Change in Pelvic Organ Prolapse Symptoms
To evaluate change in pelvic organ prolapse symptoms using the Pelvic Floor Distress Inventory- 20 (PFDI-20) sub-scale the Pelvic Organ Prolapse Distress Inventory- 6 (POPDI-6). Total score (range 0 to 100) with the higher the score the more distress.
Measured: Baseline, Week 6, and Month 6
Change in Postoperative Sexual Function Scores
To evaluate postoperative sexual function using the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Total score (range 0 to 48) with a lower score associated with poorer/worse sexual function.
Measured: Month 6
Number of Patients With Early Anatomic Recurrence
To evaluate anatomical failure of posterior compartment using a standard definition of anatomical cure will be defined as Ba or Bp at </= 0 on POP-Q examination (i.e.at or beyond hymenal ring)
Measured: Week 6
Number of Patients With Subjective Failure
To evaluate subjective failure of posterior compartment using a negative response on POPDI-6 portion of the PFDI-20 questionnaire to questions: "Do you usually have a sensation of bulging or protrusion from the vaginal area?" and "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"
Measured: Week 6 and Month 6
American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications.
To evaluate differences in adverse outcomes, using number of adverse events (AEs) as defined by the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day postoperative complications criteria. These criteria were reviewed at the week 6 data collection time interval.
Measured: 30 days
Surgery Specific Adverse Events (AEs) Measured at 6-months.
To evaluate differences in adverse outcomes, using number of surgery specific adverse events.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start14 Aug 2020
- Primary completion5 Nov 2021
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for RectoceleStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda L Merriman, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658784
- Sponsor's protocol ID
- IRB00082745
- Other IDs
- #04-20-01
- Status last verified
- Mar 2023
- First submitted
- 19 Nov 2020
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.
PubMed 20223444Kahn MA, Stanton SL. Posterior colporrhaphy: its effects on bowel and sexual function. Br J Obstet Gynaecol. 1997 Jan;104(1):82-6. doi: 10.1111/j.1471-0528.1997.tb10654.x.
PubMed 8988702Karjalainen PK, Mattsson NK, Nieminen K, Tolppanen AM, Jalkanen JT. The relationship of defecation symptoms and posterior vaginal wall prolapse in women undergoing pelvic organ prolapse surgery. Am J Obstet Gynecol. 2019 Nov;221(5):480.e1-480.e10. doi: 10.1016/j.ajog.2019.05.027. Epub 2019 May 22.
PubMed 31128111Paraiso MF, Barber MD, Muir TW, Walters MD. Rectocele repair: a randomized trial of three surgical techniques including graft augmentation. Am J Obstet Gynecol. 2006 Dec;195(6):1762-71. doi: 10.1016/j.ajog.2006.07.026.
PubMed 17132479Komesu YM, Rogers RG, Kammerer-Doak DN, Barber MD, Olsen AL. Posterior repair and sexual function. Am J Obstet Gynecol. 2007 Jul;197(1):101.e1-6. doi: 10.1016/j.ajog.2007.03.054.
PubMed 17618777Mowat A, Maher D, Baessler K, Christmann-Schmid C, Haya N, Maher C. Surgery for women with posterior compartment prolapse. Cochrane Database Syst Rev. 2018 Mar 5;3(3):CD012975. doi: 10.1002/14651858.CD012975.
PubMed 29502352Evans SKL, Abimbola O, Myers EM, Tarr ME. A Novel Injection Technique for Extended-Release Local Anesthetic After Posterior Colporrhaphy and Perineorrhaphy: A Randomized Controlled Study. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):344-350. doi: 10.1097/SPV.0000000000000855.
PubMed 32384288Luck AM, Galvin SL, Theofrastous JP. Suture erosion and wound dehiscence with permanent versus absorbable suture in reconstructive posterior vaginal surgery. Am J Obstet Gynecol. 2005 May;192(5):1626-9. doi: 10.1016/j.ajog.2004.11.029.
PubMed 15902168Madhuvrata P, Glazener C, Boachie C, Allahdin S, Bain C. A randomised controlled trial evaluating the use of polyglactin (Vicryl) mesh, polydioxanone (PDS) or polyglactin (Vicryl) sutures for pelvic organ prolapse surgery: outcomes at 2 years. J Obstet Gynaecol. 2011 Jul;31(5):429-35. doi: 10.3109/01443615.2011.576282.
PubMed 21627429Allahdin S, Glazener C, Bain C. A randomised controlled trial evaluating the use of polyglactin mesh, polydioxanone and polyglactin sutures for pelvic organ prolapse surgery. J Obstet Gynaecol. 2008 May;28(4):427-31. doi: 10.1080/01443610802150077.
PubMed 18604681Bergman I, Soderberg MW, Kjaeldgaard A, Ek M. Does the choice of suture material matter in anterior and posterior colporrhaphy? Int Urogynecol J. 2016 Sep;27(9):1357-65. doi: 10.1007/s00192-016-2981-0. Epub 2016 Mar 2.
PubMed 26935306Greenberg JA, Clark RM. Advances in suture material for obstetric and gynecologic surgery. Rev Obstet Gynecol. 2009 Summer;2(3):146-58.
PubMed 19826572Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-15.
PubMed 24920976Iavazzo C, Mamais I, Gkegkes ID. The Role of Knotless Barbed Suture in Gynecologic Surgery: Systematic Review and Meta-Analysis. Surg Innov. 2015 Oct;22(5):528-39. doi: 10.1177/1553350614554235. Epub 2014 Oct 15.
PubMed 25320107Chamsy D, King C, Lee T. The use of barbed suture for bladder and bowel repair. J Minim Invasive Gynecol. 2015 May-Jun;22(4):648-52. doi: 10.1016/j.jmig.2015.01.030. Epub 2015 Feb 7.
PubMed 25659867
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04658784
- Acronym / sponsor ID
- IRB00082745
- Conditions
- Rectocele
- Keywords
- pelvic organ prolapse, barbed suture, posterior colporrhaphy, posterior repair, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Posted 5 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized clinical trial is to compare barbed suture versus non-barbed suture at the time of posterior repair on postoperative pain scores as measured by a visual analog scale (VAS) at 6 weeks.
Study participants are randomized to use of barbed suture (2-0 V-Loc 90TM, Medtronic) or non-barbed suture (2-0 Polydioxanone, PDS® EthiconTM) in a standardized technique for posterior colporrhaphy at the time of posterior repair.
Detailed description
Pelvic organ prolapse (POP) is a growing concern for the aging female population, and symptomatic women often require surgical intervention. Approximately 200,000 surgical procedures for POP are performed annually in the United States. This number is anticipated to increase with the growth in the aging population.1 Surgical prolapse repairs are often categorized into either mesh augmented or native tissue repairs. During a native tissue repair, the surgeon uses a woman's natural tissue to repair the prolapse without augmenting the repair with synthetic mesh.
Women often have post-operative pain with native tissue posterior colporrhaphy. Native tissue posterior repairs are performed to address symptomatic posterior compartment prolapse, defects in the rectovaginal fibromuscularis, and/or a widened genital hiatus. This type of repair may improve obstructed defecatory dysfunction and bulge symptoms, but can be associated with postoperative pelvic pain and dyspareunia. Paraiso et al evaluated three surgical techniques for posterior colporrhaphy (site-specific, midline plication, and porcine graft) and found no difference in overall symptom improvement, quality of life, and post-operative sexual function. Regardless of the technique used, a posterior colporrhaphy can cause considerable postoperative pain and can contribute to de novo dyspareunia in 9-20% of women. Most studies evaluating pain after posterior colporrhaphy tend to focus on various methods of analgesia and surgical technique rather than the suture materials used.
Suture choice may contribute to postoperative pain at the time of posterior colporrhaphy. There are few studies evaluating suture in the posterior compartment with no defined standard suture material for posterior colporrhaphy. Available studies, when comparing subjective bulge and quality of life outcomes, do not demonstrate superiority of one suture type over the other. Delayed absorbable suture has the benefit of retaining tensile strength for approximately 3 months. Delayed absorbable suture material itself, however, can remain in place for up to 8 months. These properties may decrease postoperative pain by decreasing knot burden. Barbed suture has been successfully applied to vaginal cuff closure, myomectomy, sacrocolpopexy mesh attachment, and closure of bowel and bladder injuries with demonstrated reduced operative times. To date, no studies have evaluated the impact of barbed suture on postoperative pain or surgical time after posterior colporrhaphy.
The primary objective for this study is to compare delayed absorbable barbed suture versus non-barbed delayed absorbable suture at the time of posterior repair on post-operative posterior compartment pain scores, as measured by the Visual Analog Scale (VAS), at 6 weeks
Secondary objectives include a comparison of VAS pain scores in the posterior compartment at 6-months, evaluation of operative time for posterior repair in minutes, evaluation of suture burden and pelvic pain on examination of the posterior compartment, evaluation of pain versus the length of a repair, evaluation of postoperative patient quality of life (QoL) using series of standardized questionnaires, evaluation of suture cost, and a comparison of anatomical and surgical failure in the posterior compartment.
Participants will be approached for participation preoperatively. Baseline demographic data will be abstracted from the medical record. A baseline Pelvic Organ Prolapse Quantification (POP-Q) and pelvic myofascial exam will be performed. Baseline VAS and validated questionnaires: Pelvic Floor Distress Inventory-20 (PFDI-20) sub-scales Colorectal-Anal Distress Inventory-8 (CRADI-8) and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire- 12 (PISQ-12 )will be completed. Participants will be randomized in the operating room after posterior vaginal dissection to either barbed or non-barbed suture in a standardized technique. All concurrent minimally invasive pelvic reconstructive surgical procedures are allowed. Randomization will be stratified for minimally invasive (robotic or laparoscopic) versus vaginal surgery.
Perioperative care is standardized.
Participants will be scheduled for a post-operative follow up visit at approximately 6 weeks. At this visit they will have a structured postoperative interview and pelvic examination, including POP-Q, standardized assessment of suture burden and myofascial trigger points. They will also complete a VAS and validated questionnaires. Participants will be called at approximately 6 months after their original surgery. They will have a structured interview and complete VAS and complete validated questionnaires.
Adverse postoperative outcomes will be collected at each visit.
Investigators will use a standard deviation estimate of 23.4mm to detect a difference on a 100mm VAS for pain. Accounting for a 15% drop-out rate, the investigators aim to enroll 64 participants with 32 in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: 2-0 dioxanone, glycolide and trimethylene carbonateReceives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic |
| Control | Active comparator | Device: 2-0 polydioxanoneReceives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- Age 18yo or older
- English speaking
- Planned posterior colporrhaphy with or without perineorrhaphy with concomitant surgical procedures allowed
Key exclusion criteria (11 listed)
- Documented allergy or contraindication to use of suture material
- Prior mesh in posterior compartment
- Planned colpocleisis
- Current or prior rectovaginal fistula
- Planned sacrospinous ligament fixation procedure
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 |
|---|---|---|
| 2-0 dioxanone, glycolide and trimethylene carbonateAlso: 2-0 V-Loc 90TM (Medtronic)delayed absorbable, monofilament barbed suture | Device | Intervention |
| 2-0 polydioxanoneAlso: 2-0 PDS® (Ethicon)delayed absorbable, monofilament non-barbed suture | Device | Control |
Primary outcome
Post-operative Posterior Compartment Pain Scores - Posterior Repair
Time frame: Week 6
To compare delayed absorbable barbed suture versus non-barbed delayed absorbable suture at the time of posterior repair on post-operative posterior compartment pain scores, as measured by the Visual Analog Scale (VAS).The VAS is a validated scale that is ranges from 0-100mm. 0mm is equivalent to "no pain" and is located on the left. 100mm is equivalent to "worst possible pain" and is located on the right. Reported as categorical variable no pain (VAS 0), low pain (VAS 1-33), moderate pain (VAS 34-66), and high pain (VAS 67-100).
10 secondary outcomes
Post-operative Posterior Compartment Pain Scores
Time frame: Month 6
Operative Time
Time frame: Time of Surgery
Suture Burden
Time frame: At time of surgery (Intraoperative)
Change in Bowel Function Scores
Time frame: Baseline, Week 6, and month 6
Change in Pelvic Organ Prolapse Symptoms
Time frame: Baseline, Week 6, and Month 6
Change in Postoperative Sexual Function Scores
Time frame: Month 6
Number of Patients With Early Anatomic Recurrence
Time frame: Week 6
Number of Patients With Subjective Failure
Time frame: Week 6 and Month 6
American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications.
Time frame: 30 days
Surgery Specific Adverse Events (AEs) Measured at 6-months.
Time frame: month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20223444Jones KA, Shepherd JP, Oliphant SS, Wang L, Bunker CH, Lowder JL. Trends in inpatient prolapse procedures in the United States, 1979-2006. Am J Obstet Gynecol. 2010 May;202(5):501.e1-7. doi: 10.1016/j.ajog.2010.01.017. Epub 2010 Mar 11.
- Background: PubMed 8988702Kahn MA, Stanton SL. Posterior colporrhaphy: its effects on bowel and sexual function. Br J Obstet Gynaecol. 1997 Jan;104(1):82-6. doi: 10.1111/j.1471-0528.1997.tb10654.x.
- Background: PubMed 31128111Karjalainen PK, Mattsson NK, Nieminen K, Tolppanen AM, Jalkanen JT. The relationship of defecation symptoms and posterior vaginal wall prolapse in women undergoing pelvic organ prolapse surgery. Am J Obstet Gynecol. 2019 Nov;221(5):480.e1-480.e10. doi: 10.1016/j.ajog.2019.05.027. Epub 2019 May 22.
- Background: PubMed 17132479Paraiso MF, Barber MD, Muir TW, Walters MD. Rectocele repair: a randomized trial of three surgical techniques including graft augmentation. Am J Obstet Gynecol. 2006 Dec;195(6):1762-71. doi: 10.1016/j.ajog.2006.07.026.
- Background: PubMed 17618777Komesu YM, Rogers RG, Kammerer-Doak DN, Barber MD, Olsen AL. Posterior repair and sexual function. Am J Obstet Gynecol. 2007 Jul;197(1):101.e1-6. doi: 10.1016/j.ajog.2007.03.054.
- Background: PubMed 29502352Mowat A, Maher D, Baessler K, Christmann-Schmid C, Haya N, Maher C. Surgery for women with posterior compartment prolapse. Cochrane Database Syst Rev. 2018 Mar 5;3(3):CD012975. doi: 10.1002/14651858.CD012975.
- Background: PubMed 32384288Evans SKL, Abimbola O, Myers EM, Tarr ME. A Novel Injection Technique for Extended-Release Local Anesthetic After Posterior Colporrhaphy and Perineorrhaphy: A Randomized Controlled Study. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):344-350. doi: 10.1097/SPV.0000000000000855.
- Background: PubMed 15902168Luck AM, Galvin SL, Theofrastous JP. Suture erosion and wound dehiscence with permanent versus absorbable suture in reconstructive posterior vaginal surgery. Am J Obstet Gynecol. 2005 May;192(5):1626-9. doi: 10.1016/j.ajog.2004.11.029.
- Background: PubMed 21627429Madhuvrata P, Glazener C, Boachie C, Allahdin S, Bain C. A randomised controlled trial evaluating the use of polyglactin (Vicryl) mesh, polydioxanone (PDS) or polyglactin (Vicryl) sutures for pelvic organ prolapse surgery: outcomes at 2 years. J Obstet Gynaecol. 2011 Jul;31(5):429-35. doi: 10.3109/01443615.2011.576282.
- Background: PubMed 18604681Allahdin S, Glazener C, Bain C. A randomised controlled trial evaluating the use of polyglactin mesh, polydioxanone and polyglactin sutures for pelvic organ prolapse surgery. J Obstet Gynaecol. 2008 May;28(4):427-31. doi: 10.1080/01443610802150077.
- Background: PubMed 26935306Bergman I, Soderberg MW, Kjaeldgaard A, Ek M. Does the choice of suture material matter in anterior and posterior colporrhaphy? Int Urogynecol J. 2016 Sep;27(9):1357-65. doi: 10.1007/s00192-016-2981-0. Epub 2016 Mar 2.
- Background: PubMed 19826572Greenberg JA, Clark RM. Advances in suture material for obstetric and gynecologic surgery. Rev Obstet Gynecol. 2009 Summer;2(3):146-58.
- Individual participant dataSharing planned: No
Related trials for Rectocele
Not yet recruiting
Transverse Perineal Support With STARR for Anterior Rectocele With Excessive Perineal Descent
Rectocele, Perineal Descent
Recruiting
Transanal vs Transvaginal Rectal Resection for Anterior Rectocele
Rectocele; Female
Recruiting
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Colorectal Disorders, Prolapse
RecruitingPhase 3
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Pelvic Floor Prolapse, Functional Constipation
Enrolling by invitationObservational study
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Vaginal Vault Prolapse, Uterine Prolapse
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.
Amanda L Merriman, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-0 dioxanone, glycolide and trimethylene carbonate and 2-0 polydioxanone in people with Rectocele, run by Wake Forest University Health Sciences at 1 site in United States.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 6 May 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Posterior Compartment Pain Scores - Posterior Repair (time frame: Week 6). 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 NCT04658784, which also lists 28 linked publications.
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 6 May 2023.