PRP Injection Into Anal Sphincters for Fecal Incontinence
NCT ID: NCT04063293
Last Updated: 2019-08-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
EARLY_PHASE1
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-05-15
Study Completion Date
2021-02-15
Brief Summary
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The treatment of fecal incontinence after low anterior resection is problematic, and not always able to increase quality of life. Biofeedback and rehabilitation therapies are harmless and easy to use; thus, generally selected as the initial treatment modalities, however may be effective in a small portion of patients. More complex treatment techniques including sacral nerve stimulation decrease the severity of symptoms, however the implantation of the device is a costly, staged procedure. Little is known about the effectiveness of other techniques such as injectable substances on incontinence observed after low anterior resection. There is no study evaluating the safety and effectiveness of platelet rich plasma (PRP) injection for incontinent patients after low anterior resection.
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Detailed Description
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Rectal cancer is a common problem worldwide and the standard potentially curative treatment for locally advanced disease includes radical surgery appreciating oncological principals. Sphincter-saving procedures have been practiced in order to prevent a permanent stoma; however, patients underwent low anterior resection may suffer from several problems including incontinence particularly if the initial tumor is located too close to the anal canal. The actual frequency of incontinence is still unknown because of wide variation rates in several reports ranging between 0 to 80%; and may be a long-term problem since a series has presented an incidence of 36% 10 years after surgery.
Several mechanisms may cause incontinence after low anterior resection, thus several therapeutic instruments have been described considering the underlying reason. The most reasonable suspect is probably an injury to the sphincters at the time of surgery or secondary to preoperative radiation therapy, which is a commonly used modality in order to reduce local recurrence and increase the possibility of sphincter-saving procedures with the shrinkage of the tumor. Surgery and/or (chemo)radiation may not only generate sphincter injury, but also cause nerve damage and consequent denervation of the sphincters. Internal sphincters are responsible for resting pressure. Incontinence is more often and obvious if an intersphincteric resection with a hand-sewn coloanal anastomosis is attempted, since this procedure indicates the removal of internal sphincters. Several studies have revealed that up to 20% of patients have internal sphincter injuries after low anterior resection proven with endoanal ultrasound or manometer; and diminution in size of sphincters and decrease in resting pressure are correlated with incontinence grade. Mechanical anal sphincter injury may occur during the insertion of stapler; thus, incontinence may also be observed in patients with more proximally located tumors. The effect of radiation therapy on sphincter functions is also well-known, and a prospective randomized trial has shown that radiotherapy is significantly increasing incontinence rate. Another mechanism in incontinence may be related to the reduction of the capacity of neorectum, since descending colon, which is the reconstructing organ in most cases is narrower than rectum itself. Several reservoir techniques including coloplasty, colonic j-pouch and side-to-end anastomosis have been described in order to increase pooling volume of neorectum. Some other factors including decrease in sensitivity of anal canal and anal transitional zone, alteration in rectoanal inhibitory reflex, motility dysfunction of neorectum and incomplete evacuation may separately cause incontinence or increase the severity of symptoms. Instead of a sole origin, a combination of several reasons may be present at the same time making the problem more complex and the solution tougher. The treatment of incontinence is problematic, and not always able to increase quality of life. Biofeedback and rehabilitation therapies are harmless and easy to use; thus, generally selected as the initial treatment modalities, however may be effective in a small portion of patients. More complex treatment techniques including sacral nerve stimulation decrease the severity of symptoms, however the implantation of the device is a costly, staged procedure. Little is known about the effectiveness of other techniques such as injectable substances on incontinence observed after low anterior resection. Some patients may require fecal diversion in order to achieve a better quality of life.
Platelet Rich Plasma (PRP) is a thrombocyte enriched liquid, and it increases cell proliferation and collagen formation where it is injected. Platelets activate some growth factors, cytokines and other bioactive mediators, and consequently initiate and regulate wound-healing period. PRP has been used in several chronic diseases for initiating and fastening the reconstruction phase, particularly for the tendon, muscle, ligament and articular system related injuries and inflammatory situations. The effects of PRP on symptoms and healing rate in patients with lateral epicondylitis and its superiority over bupivacaine or steroid injections have been shown in cohort and prospective randomized trials. PRP is also tested for the treatment of perianal fistula. When PRP injection is combined with mucosal advancement flap procedure, it has been shown to decrease the recurrence rate. In an animal model, PRP injection into the gastrocnemius muscle has shown to increase the strength of the muscle healing. Although it has a potential, -to the best to our knowledge- there is no study evaluating the safety and effectiveness of PRP injection for incontinent patients after low anterior resection.
Methods:
This project is a single arm, cohort study evaluating the safety and effectiveness of PRP injection into the anal sphincter on incontinence and related quality of life in incontinent patients after low anterior resection for rectal cancer. All participating patients will be informed about the protocol and PRP application, and informed consent will be obtained. The study will be run at Department of General Surgery at Istanbul Medipol University Medical School (IMU) and be completed in 24 months. Local Ethical Committee has approved the protocol (protocol number: 66291034-29) and The Scientific and Technological Research Council of Turkey (TUBITAK) has granted the study (project number: 117s133). First patient accrual is planned to happen before August 2019. For the first year, only the patients who had their previous cancer operation at IMU will be included to the study, but in case of a shortage in number of patients by the end of August 2020, the inclusion of the patients who had their initial surgeries in other institutions will be permitted.
Local Ethical Committee and governors of TUBITAK will be free to monitor the trial progress at any time. Actual status of the study will be reported to TUBITAK for observation and for the continuity of grant imbursements annually (twice during the study period) and after the finalization of data analysis and publishing. Interim analysis will not be stated, since the design has not been classified as high risk.
Several mechanisms may cause incontinence after low anterior resection, thus several therapeutic instruments have been described considering the underlying reason. The most reasonable suspect is probably an injury to the sphincters at the time of surgery or secondary to preoperative radiation therapy, which is a commonly used modality in order to reduce local recurrence and increase the possibility of sphincter-saving procedures with the shrinkage of the tumor. Surgery and/or (chemo)radiation may not only generate sphincter injury, but also cause nerve damage and consequent denervation of the sphincters. Internal sphincters are responsible for resting pressure. Incontinence is more often and obvious if an intersphincteric resection with a hand-sewn coloanal anastomosis is attempted, since this procedure indicates the removal of internal sphincters. Several studies have revealed that up to 20% of patients have internal sphincter injuries after low anterior resection proven with endoanal ultrasound or manometer; and diminution in size of sphincters and decrease in resting pressure are correlated with incontinence grade. Mechanical anal sphincter injury may occur during the insertion of stapler; thus, incontinence may also be observed in patients with more proximally located tumors. The effect of radiation therapy on sphincter functions is also well-known, and a prospective randomized trial has shown that radiotherapy is significantly increasing incontinence rate. Another mechanism in incontinence may be related to the reduction of the capacity of neorectum, since descending colon, which is the reconstructing organ in most cases is narrower than rectum itself. Several reservoir techniques including coloplasty, colonic j-pouch and side-to-end anastomosis have been described in order to increase pooling volume of neorectum. Some other factors including decrease in sensitivity of anal canal and anal transitional zone, alteration in rectoanal inhibitory reflex, motility dysfunction of neorectum and incomplete evacuation may separately cause incontinence or increase the severity of symptoms. Instead of a sole origin, a combination of several reasons may be present at the same time making the problem more complex and the solution tougher. The treatment of incontinence is problematic, and not always able to increase quality of life. Biofeedback and rehabilitation therapies are harmless and easy to use; thus, generally selected as the initial treatment modalities, however may be effective in a small portion of patients. More complex treatment techniques including sacral nerve stimulation decrease the severity of symptoms, however the implantation of the device is a costly, staged procedure. Little is known about the effectiveness of other techniques such as injectable substances on incontinence observed after low anterior resection. Some patients may require fecal diversion in order to achieve a better quality of life.
Platelet Rich Plasma (PRP) is a thrombocyte enriched liquid, and it increases cell proliferation and collagen formation where it is injected. Platelets activate some growth factors, cytokines and other bioactive mediators, and consequently initiate and regulate wound-healing period. PRP has been used in several chronic diseases for initiating and fastening the reconstruction phase, particularly for the tendon, muscle, ligament and articular system related injuries and inflammatory situations. The effects of PRP on symptoms and healing rate in patients with lateral epicondylitis and its superiority over bupivacaine or steroid injections have been shown in cohort and prospective randomized trials. PRP is also tested for the treatment of perianal fistula. When PRP injection is combined with mucosal advancement flap procedure, it has been shown to decrease the recurrence rate. In an animal model, PRP injection into the gastrocnemius muscle has shown to increase the strength of the muscle healing. Although it has a potential, -to the best to our knowledge- there is no study evaluating the safety and effectiveness of PRP injection for incontinent patients after low anterior resection.
Methods:
This project is a single arm, cohort study evaluating the safety and effectiveness of PRP injection into the anal sphincter on incontinence and related quality of life in incontinent patients after low anterior resection for rectal cancer. All participating patients will be informed about the protocol and PRP application, and informed consent will be obtained. The study will be run at Department of General Surgery at Istanbul Medipol University Medical School (IMU) and be completed in 24 months. Local Ethical Committee has approved the protocol (protocol number: 66291034-29) and The Scientific and Technological Research Council of Turkey (TUBITAK) has granted the study (project number: 117s133). First patient accrual is planned to happen before August 2019. For the first year, only the patients who had their previous cancer operation at IMU will be included to the study, but in case of a shortage in number of patients by the end of August 2020, the inclusion of the patients who had their initial surgeries in other institutions will be permitted.
Local Ethical Committee and governors of TUBITAK will be free to monitor the trial progress at any time. Actual status of the study will be reported to TUBITAK for observation and for the continuity of grant imbursements annually (twice during the study period) and after the finalization of data analysis and publishing. Interim analysis will not be stated, since the design has not been classified as high risk.
Conditions
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Fecal Incontinence
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
The injection will be performed in operation room under general anesthesia with either IV sedation of laryngeal mask airway (LMA) sedation. In case a perfect relaxation will not be achieved, then the patient will be intubated. The patient will be positioned as gynecological position. 10 cc of PRP will be directly injected in external muscles at 8 locations under the guidance of endoanal ultrasound. The final condition of the sphincters will be pictured with the device. The same surgeon (MCH) will perform all procedures. No antibiotics will be used. Local anesthetics will not be injected. If the patient will feel pain after the operation, he/she will be free to use oral painkillers. The patient will be discharged from the hospital on the same night or the day after according to the patient's desire. Patients will be questioned for possible PRP complications during the hospitalization period, and they will be asked to report anytime during the study period.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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PRP injection
PRP is prepared using a special device (VS-400, Genesis Comp, Korea). For each application a kit (e+ PRP, Genesis Comp, Korea) will be used. 18 cc of venous blood will be collected from the patient into the syringe with 2 cc of anticoagulant, and will be gently inverted. The sample will be slowly injected into the e+ PRP kit. The kit will be centrifuged under 1,500G for 4 minutes, which will separate the blood components into 3 different layers. The rot at the top of the kit will be pressed until the bottom of the piston will touch the red blood cell layer, and the rot will be turned clockwise to close it. The cap will be opened and the small syringe will be connected to the cap for extracting PRP. The injection will be performed in operation room under general anesthesia with either IV sedation of laryngeal mask airway (LMA) sedation. 10 cc of PRP will be directly injected in external muscles at 8 locations under the guidance of endoanal ultrasound
Group Type
EXPERIMENTAL
Platelet Rich Plasma
Intervention Type
BIOLOGICAL
PRP injection into tha anal canal in patients underwent low anterior resection for rectal cancer
Interventions
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Platelet Rich Plasma
PRP injection into tha anal canal in patients underwent low anterior resection for rectal cancer
Intervention Type
BIOLOGICAL
Other Intervention Names
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PRP
Eligibility Criteria
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Inclusion Criteria
* incontinent patients after low anterior resection for rectal cancer
Exclusion Criteria
A. Patients who will not be suitable for initial tests:
1. Patients younger than 18 or older than 80
2. Pregnant or lactating women
3. Patients received pelvic radiation after the initial cancer surgery
4. Patients with local recurrence
5. Patients with irresectable metastasis (patients with resectable liver and/or lung metastasis will be included after metastasectomy, but patients with peritoneal metastasis who will be candidate for peritonectomy will not be included)
6. Patients under chemotherapy
7. Patients confess incontinence prior to initial cancer surgery
8. Contraindication for PRP injection: active infection, thrombocytopenia, anemia (Hgb \<10 gr/dl), allergy for buffalo thrombin
9. If the interval after the final surgery less than 12 months
10. Patient refusal
B. Patients who will be excluded according to manometer and/or endoanal ultrasound findings. Only the patients with an acceptable volume of healthy anal sphincters, an adequate reservoir capacity of neorectum and decreased sphincter strength will be included to the study after ruling out a full-thickness external sphincter tear will be the subjects of the evaluation. These patients will be excluded prior to PRP injection:
1. If manometer reveals normal resting (59-74 mm) and squeeze (124-152 mm) pressure (No clue for decreased sphincter strength)
2. If manometer reveals higher than normal volume (17-23 cc) for the first sensation, since it shows reduction of rectal sensitivity
3. If manometer reveals lessened maximum tolerable volume (MTV), since the continence may be related to the reduced volume of neorectum (For healthy volunteers the normal level of MTV is between 216 cc and 266 cc. Although normal level for neorectum after low anterior resection is not known, in a study it is accepted to be more than 60 cc as the current study \[28\]).
4. No or minimal external sphincter volume during: for inclusion the length, wide and volume of the external sphincter should be at least 16.1 mm, 6.8 mm and 6.3 cc, respectively (for inclusion all 3 measures should fulfilled). Although the actual minimal volume of external sphincter preventing incontinence is not indicated, in this study the minimal volume in healthy volunteers has been accepted \[29,30\].
5. Endoanal ultrasound examination revealing full-thickness tear in external sphincter.
1. Patients younger than 18 or older than 80
2. Pregnant or lactating women
3. Patients received pelvic radiation after the initial cancer surgery
4. Patients with local recurrence
5. Patients with irresectable metastasis (patients with resectable liver and/or lung metastasis will be included after metastasectomy, but patients with peritoneal metastasis who will be candidate for peritonectomy will not be included)
6. Patients under chemotherapy
7. Patients confess incontinence prior to initial cancer surgery
8. Contraindication for PRP injection: active infection, thrombocytopenia, anemia (Hgb \<10 gr/dl), allergy for buffalo thrombin
9. If the interval after the final surgery less than 12 months
10. Patient refusal
B. Patients who will be excluded according to manometer and/or endoanal ultrasound findings. Only the patients with an acceptable volume of healthy anal sphincters, an adequate reservoir capacity of neorectum and decreased sphincter strength will be included to the study after ruling out a full-thickness external sphincter tear will be the subjects of the evaluation. These patients will be excluded prior to PRP injection:
1. If manometer reveals normal resting (59-74 mm) and squeeze (124-152 mm) pressure (No clue for decreased sphincter strength)
2. If manometer reveals higher than normal volume (17-23 cc) for the first sensation, since it shows reduction of rectal sensitivity
3. If manometer reveals lessened maximum tolerable volume (MTV), since the continence may be related to the reduced volume of neorectum (For healthy volunteers the normal level of MTV is between 216 cc and 266 cc. Although normal level for neorectum after low anterior resection is not known, in a study it is accepted to be more than 60 cc as the current study \[28\]).
4. No or minimal external sphincter volume during: for inclusion the length, wide and volume of the external sphincter should be at least 16.1 mm, 6.8 mm and 6.3 cc, respectively (for inclusion all 3 measures should fulfilled). Although the actual minimal volume of external sphincter preventing incontinence is not indicated, in this study the minimal volume in healthy volunteers has been accepted \[29,30\].
5. Endoanal ultrasound examination revealing full-thickness tear in external sphincter.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Istanbul Medipol University Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mustafa C Haksal, MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul Medipol University Medical School
Mustafa Oncel, Prof
Role: STUDY_CHAIR
Istanbul Medipol University Medical School
Locations
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Istanbul Medipol University Medical School
Istanbul, , Turkey (Türkiye)
Site Status
RECRUITING
Countries
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Turkey (Türkiye)
Central Contacts
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Facility Contacts
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References
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Ziv Y, Zbar A, Bar-Shavit Y, Igov I. Low anterior resection syndrome (LARS): cause and effect and reconstructive considerations. Tech Coloproctol. 2013 Apr;17(2):151-62. doi: 10.1007/s10151-012-0909-3. Epub 2012 Oct 18.
Reference Type
BACKGROUND
Bryant CL, Lunniss PJ, Knowles CH, Thaha MA, Chan CL. Anterior resection syndrome. Lancet Oncol. 2012 Sep;13(9):e403-8. doi: 10.1016/S1470-2045(12)70236-X.
Reference Type
BACKGROUND
Peeters KC, van de Velde CJ, Leer JW, Martijn H, Junggeburt JM, Kranenbarg EK, Steup WH, Wiggers T, Rutten HJ, Marijnen CA. Late side effects of short-course preoperative radiotherapy combined with total mesorectal excision for rectal cancer: increased bowel dysfunction in irradiated patients--a Dutch colorectal cancer group study. J Clin Oncol. 2005 Sep 1;23(25):6199-206. doi: 10.1200/JCO.2005.14.779.
Reference Type
BACKGROUND
Lundby L, Krogh K, Jensen VJ, Gandrup P, Qvist N, Overgaard J, Laurberg S. Long-term anorectal dysfunction after postoperative radiotherapy for rectal cancer. Dis Colon Rectum. 2005 Jul;48(7):1343-9; discussion 1349-52; author reply 1352. doi: 10.1007/s10350-005-0049-1.
Reference Type
BACKGROUND
Ridolfi TJ, Berger N, Ludwig KA. Low Anterior Resection Syndrome: Current Management and Future Directions. Clin Colon Rectal Surg. 2016 Sep;29(3):239-45. doi: 10.1055/s-0036-1584500.
Reference Type
BACKGROUND
Ishiyama G, Hinata N, Kinugasa Y, Murakami G, Fujimiya M. Nerves supplying the internal anal sphincter: an immunohistochemical study using donated elderly cadavers. Surg Radiol Anat. 2014 Dec;36(10):1033-42. doi: 10.1007/s00276-014-1289-3. Epub 2014 Apr 2.
Reference Type
BACKGROUND
Konanz J, Herrle F, Weiss C, Post S, Kienle P. Quality of life of patients after low anterior, intersphincteric, and abdominoperineal resection for rectal cancer--a matched-pair analysis. Int J Colorectal Dis. 2013 May;28(5):679-88. doi: 10.1007/s00384-013-1683-z. Epub 2013 Apr 10.
Reference Type
BACKGROUND
Farouk R, Duthie GS, Lee PW, Monson JR. Endosonographic evidence of injury to the internal anal sphincter after low anterior resection: long-term follow-up. Dis Colon Rectum. 1998 Jul;41(7):888-91. doi: 10.1007/BF02235373.
Reference Type
BACKGROUND
Hirano A, Koda K, Kosugi C, Yamazaki M, Yasuda H. Damage to anal sphincter/levator ani muscles caused by operative procedure in anal sphincter-preserving operation for rectal cancer. Am J Surg. 2011 Apr;201(4):508-13. doi: 10.1016/j.amjsurg.2009.12.016. Epub 2010 Sep 29.
Reference Type
BACKGROUND
Ho YH, Tsang C, Tang CL, Nyam D, Eu KW, Seow-Choen F. Anal sphincter injuries from stapling instruments introduced transanally: randomized, controlled study with endoanal ultrasound and anorectal manometry. Dis Colon Rectum. 2000 Feb;43(2):169-73. doi: 10.1007/BF02236976.
Reference Type
BACKGROUND
Tomita R, Igarashi S, Fujisaki S. Studies on anal canal sensitivity in patients with or without soiling after low anterior resection for lower rectal cancer. Hepatogastroenterology. 2008 Jul-Aug;55(85):1311-4.
Reference Type
BACKGROUND
Kim KH, Yu CS, Yoon YS, Yoon SN, Lim SB, Kim JC. Effectiveness of biofeedback therapy in the treatment of anterior resection syndrome after rectal cancer surgery. Dis Colon Rectum. 2011 Sep;54(9):1107-13. doi: 10.1097/DCR.0b013e318221a934.
Reference Type
BACKGROUND
Visser WS, Te Riele WW, Boerma D, van Ramshorst B, van Westreenen HL. Pelvic floor rehabilitation to improve functional outcome after a low anterior resection: a systematic review. Ann Coloproctol. 2014 Jun;30(3):109-14. doi: 10.3393/ac.2014.30.3.109. Epub 2014 Jun 23.
Reference Type
BACKGROUND
Tan E, Ngo NT, Darzi A, Shenouda M, Tekkis PP. Meta-analysis: sacral nerve stimulation versus conservative therapy in the treatment of faecal incontinence. Int J Colorectal Dis. 2011 Mar;26(3):275-94. doi: 10.1007/s00384-010-1119-y. Epub 2011 Jan 29.
Reference Type
BACKGROUND
Schwandner O. Sacral neuromodulation for fecal incontinence and "low anterior resection syndrome" following neoadjuvant therapy for rectal cancer. Int J Colorectal Dis. 2013 May;28(5):665-9. doi: 10.1007/s00384-013-1687-8. Epub 2013 Apr 5.
Reference Type
BACKGROUND
Soerensen MM, Lundby L, Buntzen S, Laurberg S. Intersphincteric injected silicone biomaterial implants: a treatment for faecal incontinence. Colorectal Dis. 2009 Jan;11(1):73-6. doi: 10.1111/j.1463-1318.2008.01544.x. Epub 2008 Apr 28.
Reference Type
BACKGROUND
Kim DW, Yoon HM, Park JS, Kim YH, Kang SB. Radiofrequency energy delivery to the anal canal: is it a promising new approach to the treatment of fecal incontinence? Am J Surg. 2009 Jan;197(1):14-8. doi: 10.1016/j.amjsurg.2007.11.023. Epub 2008 Jul 9.
Reference Type
BACKGROUND
Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma: from basic science to clinical applications. Am J Sports Med. 2009 Nov;37(11):2259-72. doi: 10.1177/0363546509349921.
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BACKGROUND
Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.
Reference Type
BACKGROUND
Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010 Feb;38(2):255-62. doi: 10.1177/0363546509355445.
Reference Type
BACKGROUND
Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.
Reference Type
BACKGROUND
Gottgens KW, Vening W, van der Hagen SJ, van Gemert WG, Smeets RR, Stassen LP, Baeten CG, Breukink SO. Long-term results of mucosal advancement flap combined with platelet-rich plasma for high cryptoglandular perianal fistulas. Dis Colon Rectum. 2014 Feb;57(2):223-7. doi: 10.1097/DCR.0000000000000023.
Reference Type
BACKGROUND
Moreno-Serrano A, Garcia-Diaz JJ, Ferrer-Marquez M, Alarcon-Rodriguez R, Alvarez-Garcia A, Reina-Duarte A. Using autologous platelet-rich plasma for the treatment of complex fistulas. Rev Esp Enferm Dig. 2016 Mar;108(3):123-8. doi: 10.17235/reed.2016.3946/2015.
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BACKGROUND
Pinheiro CL, Peixinho CC, Esposito CC, Manso JE, Machado JC. Ultrasound biomicroscopy and claudication test for in vivo follow-up of muscle repair enhancement based on platelet-rich plasma therapy in a rat model of gastrocnemius laceration. Acta Cir Bras. 2016 Feb;31(2):103-10. doi: 10.1590/S0102-865020160020000004.
Reference Type
BACKGROUND
Cong JC, Chen CS, Ma MX, Xia ZX, Liu DS, Zhang FY. Laparoscopic intersphincteric resection for low rectal cancer: comparison of stapled and manual coloanal anastomosis. Colorectal Dis. 2014 May;16(5):353-8. doi: 10.1111/codi.12573.
Reference Type
BACKGROUND
Hong KD, Kim JS, Ji WB, Um JW. Midterm outcomes of injectable bulking agents for fecal incontinence: a systematic review and meta-analysis. Tech Coloproctol. 2017 Mar;21(3):203-210. doi: 10.1007/s10151-017-1593-0. Epub 2017 Mar 1.
Reference Type
BACKGROUND
Felt-Bersma RJ, Sloots CE, Poen AC, Cuesta MA, Meuwissen SG. Rectal compliance as a routine measurement: extreme volumes have direct clinical impact and normal volumes exclude rectum as a problem. Dis Colon Rectum. 2000 Dec;43(12):1732-8. doi: 10.1007/BF02236859.
Reference Type
BACKGROUND
Olsen IP, Augensen K, Wilsgaard T, Kiserud T. Three-dimensional endoanal ultrasound assessment of the anal sphincters during rest and squeeze. Acta Obstet Gynecol Scand. 2008;87(6):669-74. doi: 10.1080/00016340802088346.
Reference Type
BACKGROUND
Gregory WT, Boyles SH, Simmons K, Corcoran A, Clark AL. External anal sphincter volume measurements using 3-dimensional endoanal ultrasound. Am J Obstet Gynecol. 2006 May;194(5):1243-8. doi: 10.1016/j.ajog.2005.10.822. Epub 2006 Apr 21.
Reference Type
BACKGROUND
Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.
Reference Type
BACKGROUND
Rullier E, Laurent C, Bretagnol F, Rullier A, Vendrely V, Zerbib F. Sphincter-saving resection for all rectal carcinomas: the end of the 2-cm distal rule. Ann Surg. 2005 Mar;241(3):465-9. doi: 10.1097/01.sla.0000154551.06768.e1.
Reference Type
BACKGROUND
Other Identifiers
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IMU260702
Identifier Type: -
Identifier Source: org_study_id
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Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula
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NOT_YET_RECRUITING
NA
Management of FI After Surgery of ARM
NCT05621629
COMPLETED
Surgical Treatment of Obstructed Defecation Syndrome
NCT01899209
UNKNOWN
NA
Treatment of Anal Fissure by Activated Human Macrophages
NCT00507364
UNKNOWN
PHASE3
Effects of High-Intensity Focused Ultrasound (HIFU) Treatment on Fecal Continence and Anorretal Fisiology
NCT03289221
COMPLETED
NA
LIFT With or Without Injection of BM-MNCs
NCT05134168
COMPLETED
NA
Platelet- Rich Plasma Injection
NCT06887166
COMPLETED
NA
Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
NCT06438809
RECRUITING
PHASE1/PHASE2
Multi-Drug Analgesia vs. Standard Solution for Anal Surgery
NCT03105674
WITHDRAWN
PHASE4
Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
NCT03131297
COMPLETED
NA
The Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula
NCT00951002
UNKNOWN
Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure
NCT02395809
COMPLETED
NA
Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome
NCT03060330
RECRUITING
NA
Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug Procedure for Anal Fistula Repair
NCT01478139
UNKNOWN
PHASE3
Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug
NCT00450671
COMPLETED
PHASE3
Tissue-engineered Construct Based on Buccal Mucosa Cells and Matrix From Collagen and Polylactoglycolide Fibers
NCT03205670
UNKNOWN
EARLY_PHASE1
Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure
NCT04604483
NOT_YET_RECRUITING
NA
Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
NCT01612195
COMPLETED
PHASE2
Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele
NCT04502953
COMPLETED
NA