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Fistula clinical trials

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NCT ID: NCT05210309 Completed - Safety Clinical Trials

National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)

PRIME
Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy of the procedure has been sufficiently demonstrated and the Spanish Agency of Medication approved its application a few months ago. Being aware about the difficulties to a proper application and management of the stem cells the Spanish Stem Cell therapy group devised, in a joint activity with the Spanish Group GERM (Grupo Español de Rehabilitacion Multimodal) dedicated to expand the best surgical clinical practices, a national project for the application of the therapy. The objective is to get a homogeneous implementation in all hospitals in Spain that have being baked to use this biological therapy.

NCT ID: NCT05201209 Completed - Clinical trials for Complex Anal Fistula

LASER FiLaCâ„¢ (FISTULA LASER CLOSURE) : First-line Treatment of Complex Anal Fistulas

Start date: February 7, 2019
Phase:
Study type: Observational

Complex anal fistula is a fistula whose treatment with fistulotomy would expose the patient to an excessive risk of post-operative continence disorders. It is a challenge in proctological surgery because of the complexity of its therapeutic management in relation to the recurrences' frequency and the need to preserve sphincter function. Indeed, management is mainly based on fistulotomy techniques, but the latter expose patients to a significant alteration of their continence (less than 10% incontinence for simple fistulas but 30-50% for complex fistulas). In addition, these fistulas' management is constraining for patients due to the need for multiple interventions, long-term post-operative care and repeated discontinuation of activity. Sphincteral saving techniques have therefore developed over the last three decades and have enriched the therapeutic panel of complex fistulas. They aim to block fistula pathways without risking altering sphincter function. In addition, their surgical consequences are often simple. However, they are associated with a greater risk of failure than after fistulotomy and sometimes disappointing to the point that some of these techniques have been gradually abandoned (biological glue and plug for example). Among these sphincteral saving techniques, the investigators know the advancement flap, the injection of biological glue, plug's installation, the LIFT (Ligation of Inter sphincteric Fistula Tract), the clip's use but also, more recently a laser treatment, FiLaCâ„¢ (for Fistula Laser Closure), knowing that the idea was not new since the ND-YAG3 and CO24.5 lasers were already used in the treatment of anal fistulas, about twenty years ago, in experimental studies. This technique consists of radiating 360° laser energy radially into the fistula path to "burn" it and causing thermal destruction by coagulation of the fistula wall ans granulation tissue2. It can bo offered to any type of fistula at risk on continence, including horseshoe extensions that can be treated at the same time. It is well suited for outpatient management because the postoperative period is simple and painless. The literature is still poor on the subject with some studies published openly but the preliminary results are encouraging with a success rate of about 70%. No continence disorders reported.

NCT ID: NCT05150600 Completed - Clinical trials for Tracheo Esophageal Fistula

Inverse Ratio Ventilation in Neonatal Open Repair of Tracheoesophageal Fistula.

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

Background and Objectives: Maintaining oxygenation during neonatal open repair of esophageal atresia is difficult. Inverse ratio ventilation can be used during one lung ventilation (OLV) to improve the oxygenation and lung mechanics. The investigators will compare inverse ratio to conventional ratio ventilation during OLV in neonatal open repair of esophageal atresia regarding effect in oxygenation, hemodynamic variables, incidence of complications, and easiness of procedure. Methods: The investigators will enroll 40 term neonates undergoing open right thoracotomy for esophageal atresia repair in this prospective randomized study. The patients will be randomly assigned into 2 groups based on inspiratory to expiratory (I:E) ratio of mechanical ventilation parameters (I:E ratio will be 2:1 in IRV and 1:2 in CRV). The incidence of desaturation episodes that needs to stop the procedure and reinflation of the lung will recorded as the primary outcome while hemodynamic parameters, incidence of complications, and length of surgical procedure will be recorded as the secondary outcomes.

NCT ID: NCT05138965 Completed - Clinical trials for Healing of the Wound After Rectovaginal Fistula Surgery

the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery

Start date: January 10, 2022
Phase:
Study type: Observational

The method of Cotton Padding (mCP) was summarized by combining with many years clinical experience and the traditional ancient books.The mCP could be used in Rectovaginal Fistula (RVF) post operation effectively,in order to improve the wound.The research aim is to observe if the mCP could influence the time of staying in hospital, healing time after RVF surgery.

NCT ID: NCT05134168 Completed - Anal Fistula Clinical Trials

LIFT With or Without Injection of BM-MNCs

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

To improve the outcome of LIFT, some authors used a combined approach of LIFT. Pooled analysis of seven studies including 192 patients revealed a success rate of 83.5 % after combined LIFT approach. The use of bone marrow aspirate concentrate (BMAC) in surgery is not entirely new as it has been widely used in the treatment of bone defects, mandibular reconstruction, maxillary sinus augmentation and in critical limb ischemia. A previous study concluded that the use of BMAC to augment external anal sphincter repair strengthens wound healing by transferring cells responsible for healing directly to the site of repair. The current study aimed to assess the outcome of local injection of bone marrow mononuclear cells (BM-MNCs) in conjunction with LIFT as compared to LIFT alone in regards to healing rate, time to healing, and ultimate success rate.

NCT ID: NCT05116735 Completed - Liver Surgery Clinical Trials

Biliary Fistula and Late Recurrence of Liver Hydatid Cyst: Role of Cysto-biliary Communication

Start date: September 2010
Phase: N/A
Study type: Interventional

Purpose : The primary goals of this study were to determine the prevalence and risk factors of occult CBC and recurrence, as well as the relationship between occult cysto-biliary communications manifested as postoperative biliary leakage and recurrence. The secondary goal was to use chemical analysis of hydatid cyst fluid to assess excessive bilirubin and alkaline phosphatase levels as predictors of fistula and recurrence. Methods: This prospective multi-center experimental and follow-up study of six years duration was conducted at the hepato-biliary pancreatic units of our universities hospitals from September 2010 to September 2016. Initially, 292 patients were included, but only 244 patients enrolled in the final study.

NCT ID: NCT05115448 Completed - Pain Clinical Trials

Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time

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

A patient with an arteriovenous fistula (AVF) receiving chronic hemodialysis (HD) treatment is cannulated 312 times a year on average. The patients cannot comply with dialysis treatment and the quality of life is decreased by pain when the fistula cannot be accessed with a single attempt. Sharp pain depends on the tear in the skin, the tissue where the sensitive nerve ends receptive to pain are located, and it is particularly important during AVF puncture. Also, punctures are accompanied by haemorrhages and frequent loss of blood.

NCT ID: NCT05087407 Completed - Clinical trials for High Complex Anal Fistula

Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula

Start date: December 1, 2016
Phase: N/A
Study type: Interventional

This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula.

NCT ID: NCT05081648 Completed - Clinical trials for Chronic Kidney Diseases

Must Cannulation Technique of Vascular Access in Patients Undergoing Haemodialysis: Contributions for a Safe Nursing Intervention

MuST
Start date: January 3, 2022
Phase: N/A
Study type: Interventional

The aims of this study are to: - Determine the AVF (arteriovenous fistula) survival of patients submitted to MuST compared to those submitted to RL (rope-ladder). - Determine the AVF (arteriovenous fistula) complication rate of patients submitted to MuST compared to those submitted to RL (rope-ladder). - Analyze the intensity of pain perceived by the patient with each cannulation technique under study.

NCT ID: NCT05079139 Completed - Clinical trials for Obstetric Complication

Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET)

LONGOMUSSET
Start date: January 20, 2022
Phase: N/A
Study type: Interventional

The surgical technique of Musset has shown its effectiveness for the cure of recto-vaginal fistulas. Recto-vaginal fistulas are mostly post-obstetric (88%). The objective of this study is to investigate the outcome of patients who underwent a Musset surgical technique, as well as their postoperative functional and anatomical results at a distance from the procedure.