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IRCT20251130068162N1 IRCT 2025-12-19 Khoram-Abad University of Medical Sciences Investigating the effectiveness of combined injection of platelet-enriched plasma with Botulinum toxic in pain relief and anal fissure repair : a randomized, controlled, clinical trial study Investigating the effectiveness of combined injection of platelet-enriched plasma with Botulinum toxic in pain relief and anal fissure repair : a randomized, controlled, clinical trial study 2025-12-22 anticipated 144 Complete https://irct.ir/trial/87899 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: ‪Samples are entered into the study based on inclusion and exclusion criteria as available until the sample size is completed. Then, they are assigned to study groups using the block randomization method. For each block, permutations of 3 and 6 are considered so that the prediction of the next assignment is not possible. Randomization will be done using the blockrand package of R software. To implement the random sequence on the participants in the study, sealed, opaque envelopes with a random sequence are used. A number of envelopes are prepared, and each of the random sequences created is recorded on a card, and the cards are placed inside the envelopes in order. In order to maintain the random sequence, numbering is performed on the outer surface of the envelopes in the same order. Finally, the envelope flaps are glued and placed in boxes in order. At the start of participant enrollment, according to the order of entry of eligible participants into the study, one of the envelopes is opened in order, and the assigned group of that participant is revealed.‬. 3 anal fissure. Intervention 1: Intervention group:‪In this group, each patient receives 0.4 ml of Botox divided into two injections of equal volume on both the right and left lateral sides of the fissure. The injection is performed with a 27-gauge needle. The solution is injected close to the fissure on the lateral side. No sedation or local anesthesia will be used. Patients in the treatment group receive 20 units of botulinum toxin A (Botox 50 units per milliliter), then local anesthesia with all aseptic measures will be performed for PRP injection (ready-made PRP kits are used in this study). Anorectal dilatation is performed in the jack-knife position. Once the anal spasm is relieved, a speculum is placed in the anal canal and the fissure is observed on the clock indicator. The PRP sample is drawn and injected into the fissure bed to the submucosal layer with an insulin needle at a 45-degree angle. We wait for complete hemostasis to be achieved. Dressing is done with all aseptic precautions.‬. Intervention 2: Control group1: In this group, each patient receives 0.4 ml of Botox divided into two equal injections into the right and left lateral sides of the fissure. The injection is performed with a 27-gauge needle. The solution is injected close to the fissure on the lateral side. Sedation or local anesthesia will not be used. Patients in the treatment group receive 20 units of botulinum toxin A (50 units of Botox per ml). Intervention 3: Control group2: In this group, patients apply a fingertip amount of diltiazem gel around their anus every 12 hours. Yes - There is a plan to make this available What will be shared: "All data can potentially be shared after the individuals are de‑identified When: after impression To whom: "Researchers Conditions: Research use Where to obtain: mohadesreza8@gmail.com How to obtain: one to six month Comments:
public mohamadkazem shahmoradi
kamalvand
khoramabbad Iran (Islamic Republic of) 6816887864 +98 66 3323 6401 mohadesreza8@gmail.com Khoram-Abad University of Medical Sciences scientific mohamadreza mohades
kamalvand
khoramabbad Iran (Islamic Republic of) 6816887864 +98 66 3323 6401 mohadesreza8@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Individuals must be 18 years of age or older. must have a history of painful anal fissure (AF) for three months (90 days) or longer prior to screening No history of diabetes Presence of a radial fissure with indurated edges observed on anorectal examination Presence of either anterior or posterior anal fissure Presence of a skin tag observed during anorectal examination For individuals who have been using other topical medications, a washout period of at least two weeks prior to the start of the study will be required. 18 years no limit Both Individuals who are unwilling to undergo AF examination involving the anal canal or perianal region. Individuals who have undergone lateral sphincterotomy, anal dilation, or any previous interventions the anal canal or perianal region.Individuals who have used glyceryl trinitrate (GTN) ointment for more than one week during the 4 weeks prior to the screening visit, within a 6-month period. Anal fissure associated with other conditions (e.g., trauma, HIV infection, fistula, inflammatory bowel disease, perianal sepsis, or malignancy). Individuals who are expected to undergo another treatment plan requiring hospitalization during the study. History of cardiovascular disease, inflammatory bowel disease, chronic fecal incontinence, prior pelvic radiotherapy, fixed anal stenosis/fibrosis, major psychiatric disorders (including cigarette, drug, or alcohol users), or hematologic . Use of investigational drugs within 8 weeks or a period equal to five half-lives prior to screening, whichever is longer. diseases Individuals who may be unavailable during the trial period, are unlikely to comply with the protocol, or are otherwise deemed unsuitable by the physician for any reason. K60.1 Chronic anal fissure Treatment - Surgery Treatment - Surgery Treatment - Drugs Intervention group:‪In this group, each patient receives 0.4 ml of Botox divided into two injections of equal volume on both the right and left lateral sides of the fissure. The injection is performed with a 27-gauge needle. The solution is injected close to the fissure on the lateral side. No sedation or local anesthesia will be used. Patients in the treatment group receive 20 units of botulinum toxin A (Botox 50 units per milliliter), then local anesthesia with all aseptic measures will be performed for PRP injection (ready-made PRP kits are used in this study). Anorectal dilatation is performed in the jack-knife position. Once the anal spasm is relieved, a speculum is placed in the anal canal and the fissure is observed on the clock indicator. The PRP sample is drawn and injected into the fissure bed to the submucosal layer with an insulin needle at a 45-degree angle. We wait for complete hemostasis to be achieved. Dressing is done with all aseptic precautions.‬ Control group1: In this group, each patient receives 0.4 ml of Botox divided into two equal injections into the right and left lateral sides of the fissure. The injection is performed with a 27-gauge needle. The solution is injected close to the fissure on the lateral side. Sedation or local anesthesia will not be used. Patients in the treatment group receive 20 units of botulinum toxin A (50 units of Botox per ml). Control group2: In this group, patients apply a fingertip amount of diltiazem gel around their anus every 12 hours. Pain. Timepoint: 0,1,6,12 weeks. Method of measurement: Improvement of post-defecation anal pain based on the Numerical Rating Scale (NRS): Changes in pain scores were measured at baseline (i.e., before the start of the study) and at 1, 6, and 12 weeks after the start of the study. Pain was assessed using the Numerical Rating Scale, ranging from 0 to 10, where 0 = no pain and 10 = worst possible pain. Recurrence of the anal fissure. Timepoint: It is measured at 1 week, 6 weeks, and 12 weeks from the start date of the study. Method of measurement: Anatomical examination. univercity Approved 2025-11-22 Ethics committee of lorestan University of Medical Sciences kamalvand khoram abbad Lorestan Iran (Islamic Republic of)