An interventional study of 2-0 dioxanone, glycolide and trimethylene carbonate and 2-0 polydioxanone in Rectocele, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's enrollment of 72 is above the median of 62 across 37 interventional studies indexed under Rectocele.
Browse Rectocele studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
Device: 2-0 dioxanone, glycolide and trimethylene carbonate
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
Device: 2-0 polydioxanone
delayed absorbable, monofilament barbed suture
Also known as: 2-0 V-Loc 90TM (Medtronic)
delayed absorbable, monofilament non-barbed suture
Also known as: 2-0 PDS® (Ethicon)
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).
Time frame: Week 6
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).
Time frame: Month 6
Operative Time
To evaluate operative time for posterior repair in minutes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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?"
Time frame: 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.
Time frame: 30 days
Surgery Specific Adverse Events (AEs) Measured at 6-months.
To evaluate differences in adverse outcomes, using number of surgery specific adverse events.
Time frame: month 6
| Milestone | Intervention | Control |
|---|---|---|
| Started | 36 | 36 |
| Completed | 36 | 36 |
| Not completed | 0 | 0 |
| Milestone | Intervention | Control |
|---|---|---|
| Started | 36 | 36 |
| Completed | 34 | 31 |
| Not completed | 2 | 5 |
| Withdrew: Lost to follow-up | 2 | 5 |
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).
| Participants | Intervention | Control |
|---|---|---|
| no pain (VAS 0) | 32 | 29 |
| low pain (VAS 1-33) | 2 | 4 |
| moderate pain (VAS 34-66) | 1 | 2 |
| high pain (VAS 67- 100) | 1 | 1 |
| missing | 0 | 0 |
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).
| Participants | Intervention | Control |
|---|---|---|
| no pain (VAS 0) | 33 | 26 |
| low pain (VAS 1-33) | 1 | 1 |
| moderate pain (VAS 34-66) | 0 | 1 |
| high pain (VAS 67- 100) | 0 | 0 |
| missing | 2 | 8 |
To evaluate operative time for posterior repair in minutes.
| Minutes | Intervention | Control |
|---|---|---|
| Total procedure surgical time | 146 (75 to 180) | 168 (114 to 192) |
| Posterior repair surgical time | 21 (15.5 to 28.5) | 20.5 (15.5 to 31.5) |
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.
| centimeters | Intervention | Control |
|---|---|---|
| Suture Burden | 10.5 (7.9 to 14.4) | 26.9 (14.9 to 48.6) |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| baseline | 36.4 ± 20.8 | 36.6 ± 19.0 |
| 6 weeks | 18.1 ± 14.4 | 18.1 ± 14.9 |
| Change from baseline to 6 weeks | -18.2 ± 19.6 | -18.6 ± 22.7 |
| 6 months | 12.3 ± 12.7 | 9.6 ± 12.8 |
| Change from baseline to 6 months | -24.1 ± 22.6 | -27.9 ± 19.7 |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| baseline | 53.4 ± 19.5 | 52.1 ± 18.2 |
| 6 weeks | 13.8 ± 13.0 | 11.2 ± 12.9 |
| change from baseline to 6 weeks | -39.6 ± 20.7 | -40.9 ± 23.4 |
| 6 months | 7.2 ± 9.6 | 8.3 ± 9.0 |
| Change from baseline to 6 months | -46.7 ± 18.8 | -43.1 ± 20.9 |
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.
| score on a scale | Intervention | Control |
|---|---|---|
| Baseline | 28.1 ± 5.0 | 26.9 ± 6.3 |
| 6 months | 33.1 ± 3.2 | 31.7 ± 4.6 |
| Change from baseline to 6 months | 3.9 ± 6.8 | 4.6 ± 4.4 |
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)
| Participants | Intervention | Control |
|---|---|---|
| Number of Patients With Early Anatomic Recurrence | 0 | 0 |
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?"
| Participants | Intervention | Control |
|---|---|---|
| 6 weeks | 0 | 0 |
| 6 months | 1 | 2 |
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.
| Adverse events | Intervention | Control |
|---|---|---|
| Urinary tract infection (UTI) | 5 | 3 |
| Surgical site infection (SSI) | 0 | 1 |
| Readmission | 1 | 0 |
| Return to the operating room (OR) | 1 | 0 |
| Unplanned reintubation | 0 | 1 |
To evaluate differences in adverse outcomes, using number of surgery specific adverse events.
| Adverse events | Intervention | Control |
|---|---|---|
| de novo dyspareunia | 4 | 5 |
| new or worsening pelvic pain >3months | 1 | 4 |
| New or worsening constipation > 3 months | 2 | 1 |
| New fecal incontinence | 1 | 1 |
| Nerve injury | 1 | 0 |
| Other | 1 | 0 |
| Classified as Severe Adverse Event (SAE) | 1 | 1 |
Collected over Adverse event data was collected at 6 weeks, 6 months and 12 months time points.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/36 (0%) | 1/36 (2.8%) | 14/36 (38.9%) |
| Control | 0/36 (0%) | 1/36 (2.8%) | 13/36 (36.1%) |
| Event | Intervention | Control |
|---|---|---|
| Nerve entrapmentNervous system disorders | 1/36 | 1/36 |
| Pelvic painNervous system disorders | 1/36 | 1/36 |
| Event | Intervention | Control |
|---|---|---|
| Urinary tract infection (UTI)Infections and infestations | 5/36 | 3/36 |
| De novo dyspareuniaReproductive system and breast disorders | 4/36 | 5/36 |
| New or worsening pelvic pain > 3monthsNervous system disorders | 1/36 | 4/36 |
| New or worsening constipationGastrointestinal disorders | 2/36 | 1/36 |
| Surgical site infectionInfections and infestations | 1/36 | 1/36 |
| New fecal incontinenceGastrointestinal disorders | 1/36 | 1/36 |
| OtherBlood and lymphatic system disorders | 1/36 | 0/36 |
| Age, Continuous(Years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 57.6 ± 10.5 | 58.2 ± 11.0 | 57.9 ± 10.7 |
| Sex/Gender, Customized(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 36 | 36 | 72 |
| Race/Ethnicity, Customized(Participants) | Intervention | Control | Total |
|---|---|---|---|
| White | 34 | 34 | 68 |
| Black | 2 | 1 | 3 |
| Other | 0 | 1 | 1 |
| BMI kg/m^2(kg/m^2) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 27.8 ± 3.9 | 28.3 ± 4.9 | 28.0 ± 4.4 |
| Tobacco use(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | 1 | 1 | 2 |
| Sexually active(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | 22 | 27 | 49 |
| Vaginal estrogen use(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | 3 | 7 | 10 |
| Total Pelvic Organ Prolapse Quantification (POP-Q) Stage(Participants) | Intervention | Control | Total |
|---|---|---|---|
| POP-Q Stage 0 | 0 | 0 | 0 |
| POP-Q Stage I | 0 | 1 | 1 |
| POP-Q Stage II | 27 | 16 | 43 |
| POP-Q Stage III | 8 | 16 | 24 |
| POP-Q Stage IV | 1 | 3 | 4 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2020 to primary completion in Nov 2021, 14 months.
Results were first posted in Oct 2022, 11 months after primary completion.
Of 16 interventional studies with no phase under Rectocele, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's 14 months is below that.
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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