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Fissure in Ano clinical trials

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NCT ID: NCT06049524 Not yet recruiting - Postoperative Pain Clinical Trials

Could Preoperative Assessment of Physical and Psychological Status Help Predict Pain After Anorectal Surgery?

Start date: January 8, 2024
Phase:
Study type: Observational [Patient Registry]

The aim of this single-center prospective observational trial is to study the influence of physical and psychological factors on the intensity of pain syndrome after anorectal interventions and to determine the association between the physiological pain threshold before surgery and the level of pain syndrome after anorectal surgery. Participants undergoing surgical treatment for anorectal diseases will be asked to complete the questionnaires before and after surgery, all information will be collected to identify risk factors for severe pain syndrome after surgery. The pain threshold test will be conducted to determine the association with pain after surgery.

NCT ID: NCT05709717 Not yet recruiting - Perianal Fistula Clinical Trials

Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases

Start date: January 25, 2023
Phase:
Study type: Observational [Patient Registry]

Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire. Fistula were drained with setons prior surgery. SVF was harvested from subcutaneous abdominal fat and PRP from peripheral blood. Distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed. SVF-PRP was injected around the fistula. Patients showered their excision wound until dry. Outcomes were reported as median & interquartile range (IQR)

NCT ID: NCT05405634 Not yet recruiting - Clinical trials for Microbial Colonization

Microbiota in Chronic Anal Fissure and Its Association With Prognosis

Start date: September 2022
Phase:
Study type: Observational

In this study, we will try to answer the following questions: 1. What are the salient features of the microbiota in chronic anal fissure? 2. Are these features associated with prognosis and response to therapy? 3. Does an anal fissure swab and anal fissure tissue give comparable bacteriological results?

NCT ID: NCT04887818 Not yet recruiting - Rectal Diseases Clinical Trials

Diltiazem Ointment With Lidocaine vs. Nifedipine Ointment With Lidocaine Ointment for Treatment of Chronic Anal Fissure

Start date: June 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Anal fissure is a common anorectal diseases characterized by tear of the anoderm from the dentate line to the anal verge leading to pain and bleeding during and post defecation. It may be a benign disease, but patients suffering from disease report significantly impacted quality of life especially when it becomes chronic. Several treatment modalities have been studied for chronic anal fissure, and topical calcium channel blockers (CCB) showed promising benefit and side effect profile in treatment of chronic anal fissure. Topical Diltiazem and Nifedipine are currently widely used CCBs for chronic anal fissure after multiple studies showing their benefits compared to different agents or modalities. To the investigators' knowledge, there is no study comparing the efficacy of topical Diltiazem and Nifedipine directly. The investigators aim to design a pragmatic randomized clinical trial to compare the efficacy, and side effect profile of topical Nifedipine and Diltiazem in treatment of chronic anal fissure.

NCT ID: NCT04828889 Not yet recruiting - Acute Anal Fissure Clinical Trials

Effectiveness of Anal Enlargement by Dilators as a Therapeutic Physical Tool in Acute Anal Fissure

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

The treatment of anal fissure is mainly surgical. There are complications to this treatment, including damage to the inner anal sphincter and the appearance of fecal incontinence. Anal dilators are devices that allow gradual enlargement of the anus. To date, the use of these dilators has been in cases of sphincter scarring after a surgical procedure that has caused emptying difficulties. Only recently has the use of anal dilators been tried as a treatment for acute anal fissure. The study is designated to examine whether healing of the fissure can be achieved by conservative treatment with anal extensions and obviating the need for surgical treatment.

NCT ID: NCT04714684 Not yet recruiting - Fissure in Ano Clinical Trials

The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure

Start date: February 10, 2021
Phase: N/A
Study type: Interventional

Evaluate the effectiveness of fitostimoline proctogel in the anal fissure healing and in the need for invasive interventions (primary endpoints) and in the healing of the fissure (secondary endpoint) using Fitostimoline in addition to or without other topical devices available on the market. Three groups will be established: one for the exclusive use of fitostimoline, the second for the use of fitostimoline in addition to one of the other topical devices already on the market and the third group only for the use of other topical therapies.

NCT ID: NCT04604483 Not yet recruiting - Fissure in Ano Clinical Trials

Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure

Start date: October 1, 2024
Phase: N/A
Study type: Interventional

Chronic anal fissure rarely heals spontaneously. About 50% heal on administration om topical muscle relaxants (e.g. diltiazem) and/or injection of Botulinum toxin, but for the remainder of patients surgery (with lateral internal sphincterotomy or fissurectomy) with subsequent risks of anal incontinence has been the golden standard. Treatment with PTNS (percutaneous tibial nerve stimulation) has been showed to produce healing of chronic anal fissures not responding to topical treatment, thus avoiding the risk for debilitating anal incontinence.

NCT ID: NCT03780998 Not yet recruiting - Hemorrhoids Clinical Trials

Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases

Start date: January 1, 2019
Phase:
Study type: Observational

New produced and patented sodium pantaborat based gel will be use for treatment of benign perianal diseases (hemooroidal disease, anal fissura anda perianal fistula)

NCT ID: NCT02579330 Not yet recruiting - Hemorrhoids Clinical Trials

Trial on Use of Coloshield in Transanal and Anal Surgery

Start date: December 2015
Phase: N/A
Study type: Interventional

In various transanal and anal procedures it is desirable to clean the operating field from stool contamination. Thus mechanical bowel preparation is not well tolerated by patients. Enema does not provide sufficient effect. By the use of Coloshield a rectal washout might be performed and enable a clean operating field. In this randomized controlled trial the macroscopic contamination of the rectum with and without Coloshield is compared using the Boston Bowel Preparation Score (0-3).

NCT ID: NCT00507364 Not yet recruiting - Clinical trials for Interventional Study

Treatment of Anal Fissure by Activated Human Macrophages

Start date: n/a
Phase: Phase 3
Study type: Interventional

Chronic anal fissure is a linear tear in the distal anal canal. Most chronic fissures require intervention to heal. Surgical sphincterotomy is currently performed. However, the procedure permanently weakens the internal sphincter and may be associated with permanent complications such as incontinence. Current topical treatment or " chemical sphincterotomy" is effective in the short term for about 70% of the patient more than 50% of them will suffer from recurrence. Number of studies support the hypothesis that local ischemia is the reason for failure to heal in anal fissure. Treatment of refractory wounds by macrophage suspension is an innovative method since 1995, macrophage suspensions have been used successfully in more than 1400 patients in several hospitals in Israel without any side effect.Macrophages have key function in almost every stage of wound healing. They help in the digestion of bacteria, in a later stage, they secret IL-6, which influences endothelial cell proliferation and the initiation of angiogenesis. The study hypothesis is that local injection of activated human macrophages into chronic anal fissure may induce fissure healing.