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Rectal Fistula clinical trials

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NCT ID: NCT06303752 Not yet recruiting - Anal Fistula Clinical Trials

Tissue Therapy of Transsphincteric Anal Fistula

REP-PAF
Start date: May 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

NCT ID: NCT06113068 Not yet recruiting - Clinical trials for Complex Anal Fistulas

Fistura® Procedure for the Treatment of Complex Anal Fistulas

Start date: February 2024
Phase: N/A
Study type: Interventional

This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.

NCT ID: NCT06092398 Not yet recruiting - Anal Fistula Clinical Trials

Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula

Start date: September 2024
Phase: N/A
Study type: Interventional

To evaluate the autologous platelet rich plasma and platelet rich fibrin glue effect on the treatment of anal fistula To asses role of platelet rich plasma and platelet rich fibrin glue in decreasing recurrence of perianal fistula

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: NCT05974280 Not yet recruiting - Crohn Disease Clinical Trials

Study on the Treatment of Anal Fistulas Using Alofisel Versus Fat Autologous Stem Cells

CHAZAM
Start date: January 2024
Phase:
Study type: Observational

One of the newest and most innovative medicinal approaches is cell therapy. Several clinical trials and experimental investigations have looked into the feasibility of treating CD-related fistulas with stem cells. The current indication for ALOFISEL® (active ingredient: Darvadstrocel) is the treatment of difficult perianal Crohn's fistulas that have not responded well to at least one conventional therapy or biotherapy. This brand-new cell therapy medication is created using amplified allogeneic human adult mesenchymal stem cells from adipose tissue (ADSC). The supplier mandates that two patients be booked for a single dose of ALOFISEL® due to the medication's expensive price-roughly €54,000 for a single dose of 120 million-which cannot be stored once thawed. Only one of the two patients receives therapy; the other serves as the backup patient. By doing this, another "back-up" patient who might receive no care at all is avoided. An developing alternate approach to allogeneic ADSC injection for the treatment of complicated anal fistulas in CD is autologous fat injection. In recent years, autologous fat grafts have been the subject of in-depth research. They are popular because it is simple to get clinical samples (lipoaspirate, adipose tissue), and because there are a lot of ADSCs in adipose tissue. Additionally, ADSCs show strong immunomodulatory and regenerative capacities. We would wish to compare the effectiveness of these two injection kinds on perianal fistulas as part of our care of CD.

NCT ID: NCT05933343 Not yet recruiting - Anal Fistula Clinical Trials

Ethibond Suture vs Vessel Loop as Draining Seton for Complex Anal Fistulas

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

Drainage seton is usually placed for long-term control of symptoms, and hence it has to be effective in drainage of infection, durable, and comfortable to the patients. The present study assumes that different seton materials would attain different drainage capacities, variable durability and impact on QoL. Therefore, the study aims to compare two commonly used seton materials; Ethibond suture and vessel loop, in the management of CAF in terms of effectiveness in draining infection, percent of seton break and its timing, and change in patients' QoL as measured by a validated questionnaire.

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: NCT05677672 Not yet recruiting - Clinical trials for Complex Perianal Fistulas

The Purpose of This Study is to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula

Start date: December 30, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas

NCT ID: NCT05626023 Not yet recruiting - Crohn's Disease Clinical Trials

A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease

Start date: November 30, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease

NCT ID: NCT05476146 Not yet recruiting - Anal Fistula Clinical Trials

Re-routing in Treatment High Anal Fistula

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the role of rereouting in treatment of high anal fistula and evaluate the success rate, the recurrence and incontinence and see if rerouting of the track is a good choice in treatment of high anal fistula?