Short Term Results of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
NCT ID: NCT04320498
Last Updated: 2022-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
41 participants
INTERVENTIONAL
2019-01-01
2021-01-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
NCT05837403
PRP Injection Into Anal Sphincters for Fecal Incontinence
NCT04063293
PRP Use in Treatment of Fistula Ano
NCT04187651
Effect of Platelet-Rich Plasma Injection on Wound Healing After Fistulotomy for Simple Anal Fistula Randomized Controlled Trial (RCT)
NCT07248007
Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula
NCT06092398
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Autologous PRP has been shown to speed recovery and improve pain and quality of life scores of patients treated for chronic wounds.PRP reduced complaints and accelerated epithelialization and healing in patients with chronic anal fissures. PRP, which can be obtained easily and did not have any harmful patient effects may be an alternative to surgery in patients with chronic anal fissures. The duration of symptoms should be considered during the evaluation of treatment options.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
control group
The control patients self-administered topical glyceryl trinitrate, in the perianal area twice a day (Anrecta, Consentis Pharmaceuticals, Istanbul, Turkey)
Anrecta
self-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day
sitz bath
participants were told to take a hot water sitz bath once a day
nutrition regulation
The study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily
PRP group
PRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group.
prp injection
PRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group.
Anrecta
self-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day
sitz bath
participants were told to take a hot water sitz bath once a day
nutrition regulation
The study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
prp injection
PRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group.
Anrecta
self-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day
sitz bath
participants were told to take a hot water sitz bath once a day
nutrition regulation
The study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The diagnosis of chronic anal fissure required :
* the presence of internal sphincter muscle fibers in the base of the fissure
* hypertrophic anal papillae on digital rectal examination
Exclusion Criteria
* with painful defecation for less than 2 months,
* atypical fissure location or multiple anal fissures away from the midline
* inflammatory bowel disease
* cancer
* history of trauma
* tuberculosis
* immune suppression
* sexually transmitted disease
* a disease possibly associated with a fissure
* a history of anal surgery
* previous treatment for anal fissure
* current pregnancy .
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul Medipol University Hospital
OTHER
KTO Karatay University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yusuf Tanrikulu
Assoc Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Karatay Medicana Üniversitesi
Konya, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Altomare DF, Binda GA, Canuti S, Landolfi V, Trompetto M, Villani RD. The management of patients with primary chronic anal fissure: a position paper. Tech Coloproctol. 2011 Jun;15(2):135-41. doi: 10.1007/s10151-011-0683-7. Epub 2011 May 3.
Gupta PJ. Closed anal sphincter manipulation technique for chronic anal fissure. Rev Gastroenterol Mex. 2008 Jan-Mar;73(1):29-32.
Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.
Medhi B, Rao RS, Prakash A, Prakash O, Kaman L, Pandhi P. Recent advances in the pharmacotherapy of chronic anal fissure: an update. Asian J Surg. 2008 Jul;31(3):154-63. doi: 10.1016/S1015-9584(08)60078-0.
Wu PI, Diaz R, Borg-Stein J. Platelet-Rich Plasma. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):825-853. doi: 10.1016/j.pmr.2016.06.002.
Dhillon RS, Schwarz EM, Maloney MD. Platelet-rich plasma therapy - future or trend? Arthritis Res Ther. 2012 Aug 8;14(4):219. doi: 10.1186/ar3914.
Li F, Li Q, Wang LF. [Advances in the research of effects of mesenchymal stem cells, exosomes, and platelet-rich plasma in wound repair]. Zhonghua Shao Shang Za Zhi. 2019 Oct 20;35(10):764-768. doi: 10.3760/cma.j.issn.1009-2587.2019.10.012. Chinese.
Etulain J, Mena HA, Meiss RP, Frechtel G, Gutt S, Negrotto S, Schattner M. An optimised protocol for platelet-rich plasma preparation to improve its angiogenic and regenerative properties. Sci Rep. 2018 Jan 24;8(1):1513. doi: 10.1038/s41598-018-19419-6.
Hancock BD. The internal sphincter and anal fissure. Br J Surg. 1977 Feb;64(2):92-5. doi: 10.1002/bjs.1800640204.
EISENHAMMER S. The evaluation of the internal anal sphincterotomy operation with special reference to anal fissure. Surg Gynecol Obstet. 1959 Nov;109:583-90. No abstract available.
Notaras MJ. Lateral subcutaneous sphincterotomy for anal fissure--a new technique. Proc R Soc Med. 1969 Jul 7;62(7):713. doi: 10.1177/003591576906200737. No abstract available.
Casillas S, Hull TL, Zutshi M, Trzcinski R, Bast JF, Xu M. Incontinence after a lateral internal sphincterotomy: are we underestimating it? Dis Colon Rectum. 2005 Jun;48(6):1193-9. doi: 10.1007/s10350-004-0914-3.
Kang GS, Kim BS, Choi PS, Kang DW. Evaluation of healing and complications after lateral internal sphincterotomy for chronic anal fissure: marginal suture of incision vs. open left incision: prospective, randomized, controlled study. Dis Colon Rectum. 2008 Mar;51(3):329-33. doi: 10.1007/s10350-007-9122-2. Epub 2008 Jan 4.
Rattan S, Chakder S. Role of nitric oxide as a mediator of internal anal sphincter relaxation. Am J Physiol. 1992 Jan;262(1 Pt 1):G107-12. doi: 10.1152/ajpgi.1992.262.1.G107.
Loder PB, Kamm MA, Nicholls RJ, Phillips RK. 'Reversible chemical sphincterotomy' by local application of glyceryl trinitrate. Br J Surg. 1994 Sep;81(9):1386-9. doi: 10.1002/bjs.1800810949.
Collins EE, Lund JN. A review of chronic anal fissure management. Tech Coloproctol. 2007 Sep;11(3):209-23. doi: 10.1007/s10151-007-0355-9. Epub 2007 Aug 3.
Lund JN, Scholefield JH. A randomised, prospective, double-blind, placebo-controlled trial of glyceryl trinitrate ointment in treatment of anal fissure. Lancet. 1997 Jan 4;349(9044):11-4. doi: 10.1016/S0140-6736(96)06090-4.
Shah V, Lyford G, Gores G, Farrugia G. Nitric oxide in gastrointestinal health and disease. Gastroenterology. 2004 Mar;126(3):903-13. doi: 10.1053/j.gastro.2003.11.046.
Wang HL, Avila G. Platelet rich plasma: myth or reality? Eur J Dent. 2007 Oct;1(4):192-4. No abstract available.
Masoudi E, Ribas J, Kaushik G, Leijten J, Khademhosseini A. Platelet-Rich Blood Derivatives for Stem Cell-Based Tissue Engineering and Regeneration. Curr Stem Cell Rep. 2016 Mar;2(1):33-42. doi: 10.1007/s40778-016-0034-8. Epub 2016 Feb 13.
Schouten WR, Briel JW, Auwerda JJ, De Graaf EJ. Ischaemic nature of anal fissure. Br J Surg. 1996 Jan;83(1):63-5. doi: 10.1002/bjs.1800830120.
Schouten WR, Briel JW, Auwerda JJ. Relationship between anal pressure and anodermal blood flow. The vascular pathogenesis of anal fissures. Dis Colon Rectum. 1994 Jul;37(7):664-9. doi: 10.1007/BF02054409.
Margolis DJ, Kantor J, Santanna J, Strom BL, Berlin JA. Effectiveness of platelet releasate for the treatment of diabetic neuropathic foot ulcers. Diabetes Care. 2001 Mar;24(3):483-8. doi: 10.2337/diacare.24.3.483.
Kazakos K, Lyras DN, Verettas D, Tilkeridis K, Tryfonidis M. The use of autologous PRP gel as an aid in the management of acute trauma wounds. Injury. 2009 Aug;40(8):801-5. doi: 10.1016/j.injury.2008.05.002. Epub 2008 Aug 13.
Dionyssiou D, Demiri E, Foroglou P, Cheva A, Saratzis N, Aivazidis C, Karkavelas G. The effectiveness of intralesional injection of platelet-rich plasma in accelerating the healing of chronic ulcers: an experimental and clinical study. Int Wound J. 2013 Aug;10(4):397-406. doi: 10.1111/j.1742-481X.2012.00996.x. Epub 2012 Jun 4.
Menchisheva Y, Mirzakulova U, Yui R. Use of platelet-rich plasma to facilitate wound healing. Int Wound J. 2019 Apr;16(2):343-353. doi: 10.1111/iwj.13034. Epub 2018 Nov 15.
Motie MR, Hashemi P. Chronic Anal Fissure: A Comparative Study of Medical Treatment Versus Surgical Sphincterotomy. Acta Med Iran. 2016 Jul;54(7):437-40.
Valizadeh N, Jalaly NY, Hassanzadeh M, Kamani F, Dadvar Z, Azizi S, Salehimarzijarani B. Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial. Langenbecks Arch Surg. 2012 Oct;397(7):1093-8. doi: 10.1007/s00423-012-0948-2. Epub 2012 Mar 20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
122
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.