Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy

Rectocele Clinical Trial

Official title:

Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04658784
• Other study ID #: IRB00082745
• Secondary ID: #04-20-01
• Status: Completed
• Phase: N/A
• Start date: August 14, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 15, 2022
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectocele

Intervention

Device:
• 2-0 dioxanone, glycolide and trimethylene carbonate
delayed absorbable, monofilament barbed suture
• 2-0 polydioxanone
delayed absorbable, monofilament non-barbed suture

Locations

Country	Name	City	State
United States	Atrium Health	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (28)

Allahdin 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. — View Citation

Barber MD, Brubaker L, Nygaard I, Wheeler TL 2nd, Schaffer J, Chen Z, Spino C; Pelvic Floor Disorders Network. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009 Sep;114(3):600-609. doi: 10.1097/AOG.0b013e3181b2b1ae. — View Citation

Bergman 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. — View Citation

Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61. doi: 10.1097/00000542-200112000-00013. — View Citation

Chamsy 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. — View Citation

Christmann-Schmid C, Wierenga AP, Frischknecht E, Maher C. A Prospective Observational Study of the Classification of the Perineum and Evaluation of Perineal Repair at the Time of Posterior Colporrhaphy. Female Pelvic Med Reconstr Surg. 2016 Nov/Dec;22(6):453-459. doi: 10.1097/SPV.0000000000000314. — View Citation

Crisp CC, Bandi S, Kleeman SD, Oakley SH, Vaccaro CM, Estanol MV, Fellner AN, Pauls RN. Patient-controlled versus scheduled, nurse-administered analgesia following vaginal reconstructive surgery: a randomized trial. Am J Obstet Gynecol. 2012 Nov;207(5):433.e1-6. doi: 10.1016/j.ajog.2012.06.040. Epub 2012 Jun 20. — View Citation

Culligan PJ. Surgical repair of the posterior compartment. Clin Obstet Gynecol. 2005 Sep;48(3):704-12. doi: 10.1097/01.grf.0000170426.61066.34. No abstract available. — View Citation

Evans 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. — View Citation

Greenberg JA, Clark RM. Advances in suture material for obstetric and gynecologic surgery. Rev Obstet Gynecol. 2009 Summer;2(3):146-58. — View Citation

Greenberg 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. — View Citation

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. — View Citation

He S, Falk K, Kannan A, Kelley RS. An Alternative Approach to Posterior Colporrhaphy Plication Using Delayed Absorbable Unidirectional Barbed Suture. Female Pelvic Med Reconstr Surg. 2020 Feb;26(2):107-110. doi: 10.1097/SPV.0000000000000828. No abstract available. — View Citation

Iavazzo 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. — View Citation

Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8. — View Citation

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. — View Citation

Kahn 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. — View Citation

Karjalainen 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. — View Citation

Komesu 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. — View Citation

Lee JS, Hobden E, Stiell IG, Wells GA. Clinically important change in the visual analog scale after adequate pain control. Acad Emerg Med. 2003 Oct;10(10):1128-30. doi: 10.1111/j.1553-2712.2003.tb00586.x. — View Citation

Luck 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. — View Citation

Madhuvrata 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. — View Citation

Maher CF, Qatawneh AM, Baessler K, Schluter PJ. Midline rectovaginal fascial plication for repair of rectocele and obstructed defecation. Obstet Gynecol. 2004 Oct;104(4):685-9. doi: 10.1097/01.AOG.0000139833.48063.03. — View Citation

Meister MR, Sutcliffe S, Ghetti C, Chu CM, Spitznagle T, Warren DK, Lowder JL. Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain. Am J Obstet Gynecol. 2019 Mar;220(3):255.e1-255.e9. doi: 10.1016/j.ajog.2018.11.1106. Epub 2018 Dec 7. — View Citation

Mowat 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. — View Citation

Paraiso 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. — View Citation

Westermann LB, Crisp CC, Mazloomdoost D, Kleeman SD, Pauls RN. Comparative Perioperative Pain and Recovery in Women Undergoing Vaginal Reconstruction Versus Robotic Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):95-100. doi: 10.1097/SPV.0000000000000368. — View Citation

Wiggins T, Majid MS, Markar SR, Loy J, Agrawal S, Koak Y. Benefits of barbed suture utilisation in gastrointestinal anastomosis: a systematic review and meta-analysis. Ann R Coll Surg Engl. 2020 Feb;102(2):153-159. doi: 10.1308/rcsann.2019.0106. Epub 2019 Sep 11. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Week 6
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).	Month 6
Secondary	Operative Time	To evaluate operative time for posterior repair in minutes.	Time of Surgery
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.	At time of surgery (Intraoperative)
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.	Baseline, Week 6, and month 6
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.	Baseline, Week 6, and Month 6
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.	Month 6
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	Week 6
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?"	Week 6 and Month 6
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.	30 days
Secondary	Surgery Specific Adverse Events (AEs) Measured at 6-months.	To evaluate differences in adverse outcomes, using number of surgery specific adverse events.	month 6