Rectocele
Conditions
Keywords
pelvic organ prolapse, barbed suture, posterior colporrhaphy, posterior repair, pain
Brief 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. 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.
Interventions
DEVICE2-0 dioxanone, glycolide and trimethylene carbonate
delayed absorbable, monofilament barbed suture
DEVICE2-0 polydioxanone
delayed absorbable, monofilament non-barbed suture
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women * Age 18yo or older * English speaking * Planned posterior colporrhaphy with or without perineorrhaphy with concomitant surgical procedures allowed
Exclusion criteria
* 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 * Chronic narcotic medication use * Active vulvodynia * Non-English speaking * Inability to provide informed consent * Planned combined colorectal/anorectal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Posterior Compartment Pain Scores - Posterior Repair | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Posterior Compartment Pain Scores | Month 6 | 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). |
| Operative Time | Time of Surgery | To evaluate operative time for posterior repair in minutes. |
| Change in Bowel Function Scores | Baseline, Week 6, and month 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. |
| Change in Pelvic Organ Prolapse Symptoms | Baseline, Week 6, and Month 6 | 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. |
| Suture Burden | At time of surgery (Intraoperative) | 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. |
| Number of Patients With Early Anatomic Recurrence | Week 6 | 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) |
| Number of Patients With Subjective Failure | Week 6 and Month 6 | 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? |
| American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | 30 days | 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. |
| Surgery Specific Adverse Events (AEs) Measured at 6-months. | month 6 | To evaluate differences in adverse outcomes, using number of surgery specific adverse events. |
| Change in Postoperative Sexual Function Scores | Month 6 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture | 36 |
| Control Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture | 36 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 6-month Follow-up | Lost to Follow-up | 2 | 5 |
Baseline characteristics
| Characteristic | Total | Control | Intervention |
|---|---|---|---|
| Age, Continuous | 57.9 Years STANDARD_DEVIATION 10.7 | 58.2 Years STANDARD_DEVIATION 11 | 57.6 Years STANDARD_DEVIATION 10.5 |
| BMI kg/m^2 | 28.0 kg/m^2 STANDARD_DEVIATION 4.4 | 28.3 kg/m^2 STANDARD_DEVIATION 4.9 | 27.8 kg/m^2 STANDARD_DEVIATION 3.9 |
| Posterior Compartment Pelvic Organ Prolapse Quantification (POP-Q) Stage (0-IV) POP-Q Stage 0 | 3 Participants | 1 Participants | 2 Participants |
| Posterior Compartment Pelvic Organ Prolapse Quantification (POP-Q) Stage (0-IV) POP-Q Stage I | 12 Participants | 4 Participants | 8 Participants |
| Posterior Compartment Pelvic Organ Prolapse Quantification (POP-Q) Stage (0-IV) POP-Q Stage II | 51 Participants | 25 Participants | 26 Participants |
| Posterior Compartment Pelvic Organ Prolapse Quantification (POP-Q) Stage (0-IV) POP-Q Stage III | 5 Participants | 5 Participants | 0 Participants |
| Posterior Compartment Pelvic Organ Prolapse Quantification (POP-Q) Stage (0-IV) POP-Q Stage IV | 1 Participants | 1 Participants | 0 Participants |
| Prior pelvic reconstructive surgery | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 68 Participants | 34 Participants | 34 Participants |
| Sex/Gender, Customized Female | 72 Participants | 36 Participants | 36 Participants |
| Sexually active | 49 Participants | 27 Participants | 22 Participants |
| Tobacco use | 2 Participants | 1 Participants | 1 Participants |
| Total Pelvic Organ Prolapse Quantification (POP-Q) Stage POP-Q Stage 0 | 0 Participants | 0 Participants | 0 Participants |
| Total Pelvic Organ Prolapse Quantification (POP-Q) Stage POP-Q Stage I | 1 Participants | 1 Participants | 0 Participants |
| Total Pelvic Organ Prolapse Quantification (POP-Q) Stage POP-Q Stage II | 43 Participants | 16 Participants | 27 Participants |
| Total Pelvic Organ Prolapse Quantification (POP-Q) Stage POP-Q Stage III | 24 Participants | 16 Participants | 8 Participants |
| Total Pelvic Organ Prolapse Quantification (POP-Q) Stage POP-Q Stage IV | 4 Participants | 3 Participants | 1 Participants |
| Vaginal estrogen use | 10 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 36 |
| other Total, other adverse events | 14 / 36 | 13 / 36 |
| serious Total, serious adverse events | 1 / 36 | 1 / 36 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Post-operative Posterior Compartment Pain Scores - Posterior Repair | low pain (VAS 1-33) | 2 Participants |
| Intervention | Post-operative Posterior Compartment Pain Scores - Posterior Repair | high pain (VAS 67- 100) | 1 Participants |
| Intervention | Post-operative Posterior Compartment Pain Scores - Posterior Repair | moderate pain (VAS 34-66) | 1 Participants |
| Intervention | Post-operative Posterior Compartment Pain Scores - Posterior Repair | missing | 0 Participants |
| Intervention | Post-operative Posterior Compartment Pain Scores - Posterior Repair | no pain (VAS 0) | 32 Participants |
| Control | Post-operative Posterior Compartment Pain Scores - Posterior Repair | missing | 0 Participants |
| Control | Post-operative Posterior Compartment Pain Scores - Posterior Repair | no pain (VAS 0) | 29 Participants |
| Control | Post-operative Posterior Compartment Pain Scores - Posterior Repair | low pain (VAS 1-33) | 4 Participants |
| Control | Post-operative Posterior Compartment Pain Scores - Posterior Repair | moderate pain (VAS 34-66) | 2 Participants |
| Control | Post-operative Posterior Compartment Pain Scores - Posterior Repair | high pain (VAS 67- 100) | 1 Participants |
Comparison: OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.p-value: 0.3295% CI: [0.13, 1.92]Regression, Logistic
Secondary
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
Population: Comparison of 30 day ACS NSQIP complications in intervention and control groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | Surgical site infection (SSI) | 0 Adverse events |
| Intervention | American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | Return to the operating room (OR) | 1 Adverse events |
| Intervention | American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | Readmission | 1 Adverse events |
| Intervention | American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | Unplanned reintubation | 0 Adverse events |
| Intervention | American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | Urinary tract infection (UTI) | 5 Adverse events |
| Control | American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | Unplanned reintubation | 1 Adverse events |
| Control | American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | Urinary tract infection (UTI) | 3 Adverse events |
| Control | American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | Surgical site infection (SSI) | 1 Adverse events |
| Control | American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | Readmission | 0 Adverse events |
| Control | American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | Return to the operating room (OR) | 0 Adverse events |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Bowel Function Scores | 6 weeks | 18.1 score on a scale | Standard Deviation 14.4 |
| Intervention | Change in Bowel Function Scores | 6 months | 12.3 score on a scale | Standard Deviation 12.7 |
| Intervention | Change in Bowel Function Scores | Change from baseline to 6 weeks | -18.2 score on a scale | Standard Deviation 19.6 |
| Intervention | Change in Bowel Function Scores | Change from baseline to 6 months | -24.1 score on a scale | Standard Deviation 22.6 |
| Intervention | Change in Bowel Function Scores | baseline | 36.4 score on a scale | Standard Deviation 20.8 |
| Control | Change in Bowel Function Scores | Change from baseline to 6 months | -27.9 score on a scale | Standard Deviation 19.7 |
| Control | Change in Bowel Function Scores | baseline | 36.6 score on a scale | Standard Deviation 19 |
| Control | Change in Bowel Function Scores | 6 weeks | 18.1 score on a scale | Standard Deviation 14.9 |
| Control | Change in Bowel Function Scores | Change from baseline to 6 weeks | -18.6 score on a scale | Standard Deviation 22.7 |
| Control | Change in Bowel Function Scores | 6 months | 9.6 score on a scale | Standard Deviation 12.8 |
Comparison: Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6- weeks.p-value: 195% CI: [-3.5, 8.7]Regression, Linear
Comparison: Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6-months.95% CI: [-5.6, 3.2]Regression, Linear
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Pelvic Organ Prolapse Symptoms | 6 weeks | 13.8 score on a scale | Standard Deviation 13 |
| Intervention | Change in Pelvic Organ Prolapse Symptoms | 6 months | 7.2 score on a scale | Standard Deviation 9.6 |
| Intervention | Change in Pelvic Organ Prolapse Symptoms | change from baseline to 6 weeks | -39.6 score on a scale | Standard Deviation 20.7 |
| Intervention | Change in Pelvic Organ Prolapse Symptoms | Change from baseline to 6 months | -46.7 score on a scale | Standard Deviation 18.8 |
| Intervention | Change in Pelvic Organ Prolapse Symptoms | baseline | 53.4 score on a scale | Standard Deviation 19.5 |
| Control | Change in Pelvic Organ Prolapse Symptoms | Change from baseline to 6 months | -43.1 score on a scale | Standard Deviation 20.9 |
| Control | Change in Pelvic Organ Prolapse Symptoms | baseline | 52.1 score on a scale | Standard Deviation 18.2 |
| Control | Change in Pelvic Organ Prolapse Symptoms | 6 weeks | 11.2 score on a scale | Standard Deviation 12.9 |
| Control | Change in Pelvic Organ Prolapse Symptoms | change from baseline to 6 weeks | -40.9 score on a scale | Standard Deviation 23.4 |
| Control | Change in Pelvic Organ Prolapse Symptoms | 6 months | 8.3 score on a scale | Standard Deviation 9 |
Comparison: Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-weeks.p-value: 195% CI: [-6.6, 6.9]Regression, Linear
p-value: 195% CI: [-3.1, 8.6]Regression, Linear
Secondary
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
Population: Different number of patients were sexually active at measured time points, baseline and 6 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Postoperative Sexual Function Scores | Baseline | 28.1 score on a scale | Standard Deviation 5 |
| Intervention | Change in Postoperative Sexual Function Scores | 6 months | 33.1 score on a scale | Standard Deviation 3.2 |
| Intervention | Change in Postoperative Sexual Function Scores | Change from baseline to 6 months | 3.9 score on a scale | Standard Deviation 6.8 |
| Control | Change in Postoperative Sexual Function Scores | Baseline | 26.9 score on a scale | Standard Deviation 6.3 |
| Control | Change in Postoperative Sexual Function Scores | 6 months | 31.7 score on a scale | Standard Deviation 4.6 |
| Control | Change in Postoperative Sexual Function Scores | Change from baseline to 6 months | 4.6 score on a scale | Standard Deviation 4.4 |
Comparison: Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6 months.p-value: 195% CI: [-4.4, 1.3]Regression, Linear
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Patients With Early Anatomic Recurrence | 0 Participants |
| Control | Number of Patients With Early Anatomic Recurrence | 0 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Patients With Subjective Failure | 6 weeks | 0 Participants |
| Intervention | Number of Patients With Subjective Failure | 6 months | 1 Participants |
| Control | Number of Patients With Subjective Failure | 6 weeks | 0 Participants |
| Control | Number of Patients With Subjective Failure | 6 months | 2 Participants |
Secondary
Operative Time
To evaluate operative time for posterior repair in minutes.
Time frame: Time of Surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention | Operative Time | Total procedure surgical time | 146 Minutes |
| Intervention | Operative Time | Posterior repair surgical time | 21 Minutes |
| Control | Operative Time | Total procedure surgical time | 168 Minutes |
| Control | Operative Time | Posterior repair surgical time | 20.5 Minutes |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Post-operative Posterior Compartment Pain Scores | low pain (VAS 1-33) | 1 Participants |
| Intervention | Post-operative Posterior Compartment Pain Scores | high pain (VAS 67- 100) | 0 Participants |
| Intervention | Post-operative Posterior Compartment Pain Scores | moderate pain (VAS 34-66) | 0 Participants |
| Intervention | Post-operative Posterior Compartment Pain Scores | missing | 2 Participants |
| Intervention | Post-operative Posterior Compartment Pain Scores | no pain (VAS 0) | 33 Participants |
| Control | Post-operative Posterior Compartment Pain Scores | missing | 8 Participants |
| Control | Post-operative Posterior Compartment Pain Scores | no pain (VAS 0) | 26 Participants |
| Control | Post-operative Posterior Compartment Pain Scores | low pain (VAS 1-33) | 1 Participants |
| Control | Post-operative Posterior Compartment Pain Scores | moderate pain (VAS 34-66) | 1 Participants |
| Control | Post-operative Posterior Compartment Pain Scores | high pain (VAS 67- 100) | 0 Participants |
Comparison: OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.p-value: 195% CI: [0.04, 5.65]Regression, Logistic
Secondary
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
Population: Analysis of surgery specific adverse events in intervention and control groups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Surgery Specific Adverse Events (AEs) Measured at 6-months. | New or worsening constipation > 3 months | 2 Adverse events |
| Intervention | Surgery Specific Adverse Events (AEs) Measured at 6-months. | Nerve injury | 1 Adverse events |
| Intervention | Surgery Specific Adverse Events (AEs) Measured at 6-months. | new or worsening pelvic pain >3months | 1 Adverse events |
| Intervention | Surgery Specific Adverse Events (AEs) Measured at 6-months. | Other | 1 Adverse events |
| Intervention | Surgery Specific Adverse Events (AEs) Measured at 6-months. | New fecal incontinence | 1 Adverse events |
| Intervention | Surgery Specific Adverse Events (AEs) Measured at 6-months. | Classified as Severe Adverse Event (SAE) | 1 Adverse events |
| Intervention | Surgery Specific Adverse Events (AEs) Measured at 6-months. | de novo dyspareunia | 4 Adverse events |
| Control | Surgery Specific Adverse Events (AEs) Measured at 6-months. | Classified as Severe Adverse Event (SAE) | 1 Adverse events |
| Control | Surgery Specific Adverse Events (AEs) Measured at 6-months. | de novo dyspareunia | 5 Adverse events |
| Control | Surgery Specific Adverse Events (AEs) Measured at 6-months. | new or worsening pelvic pain >3months | 4 Adverse events |
| Control | Surgery Specific Adverse Events (AEs) Measured at 6-months. | New or worsening constipation > 3 months | 1 Adverse events |
| Control | Surgery Specific Adverse Events (AEs) Measured at 6-months. | New fecal incontinence | 1 Adverse events |
| Control | Surgery Specific Adverse Events (AEs) Measured at 6-months. | Nerve injury | 0 Adverse events |
| Control | Surgery Specific Adverse Events (AEs) Measured at 6-months. | Other | 0 Adverse events |
Secondary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Suture Burden | 10.5 centimeters |
| Control | Suture Burden | 26.9 centimeters |