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Fistula clinical trials

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NCT ID: NCT06391281 Not yet recruiting - Hemodialysis Clinical Trials

Effect of Fistula Training in Hemodialysis Patients

Start date: April 26, 2024
Phase: N/A
Study type: Interventional

It was planned to examine the effect of fistula-related education given to patients receiving hemodialysis treatment on their self-care behaviors. Nurse-led education about fistula for hemodialysis patients affects fistula self-care behaviors. Nurse-led training regarding fistula to hemodialysis patients does not affect fistula self-care behaviors.

NCT ID: NCT06336226 Not yet recruiting - Clinical trials for Arterio-venous Fistula

Brachio Basilic Arterio Venous Fistula One Stage vs Two Stage

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

The aim of this work was to compare primary failure rates and the primary functional patency of one-stage vs two stage brachiobasilic fistulas to compare the two surgical techniques .

NCT ID: NCT06335862 Not yet recruiting - Oesophageal Atresia Clinical Trials

Primary Posterior Tracheopexy Prevents Tracheal Collapse

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

Introduction: Children born with a blind-ending gullet (oesophagus), or Oesophageal Atresia (OA), need to undergo surgical correction in the first week of life. OA is often accompanied by a weakened windpipe (trachea), known as tracheomalacia (TM). TM entails that the windpipe collapses during expiration. Severe TM can cause respiratory symptoms, including frequent respiratory tract infections and blue spells, that can potentially lead to life-threatening events. In some patients, major secondary surgical treatment may be indicated. This surgical procedure involves widening the trachea (using sutures) to prevent collapse, known as secondary posterior tracheopexy (SPT). Prior to performing this SPT, complications and negative consequences of TM may have already occurred. This may be prevented by performing this procedure during the primary OA correction, called a primary posterior tracheopexy (PPT). The aim of this trial is to determine if a PPT can decrease - or prevent - tracheal collapse in newborns with OA and TM, compared to a wait-and-see policy (no-PPT). Methods: This is an international multicentre double-blind randomised controlled trial. Seventy eight children with OA type C will be included. Patients will be included after written parental informed consent. Half of the patients will be randomly allocated to the PPT-group and half to the no-PPT-group. The degree and location of TM are evaluated through preoperative, intraoperative and two postoperative videoscopic examinations of the trachea (tracheobronchoscopy). Whether TM symptoms occur is assessed during three routine follow-up consultations until the age of 6 months. The primary outcome is the degree of collapse of the tracheal wall during the intraoperative tracheobronchoscopy (after performing the PPT/no-PPT), measured in percentages. Risks and burden: Since OA correction with PPT (more recently implemented in centres of expertise) and without PPT (wait-and-see policy) are both accepted and safe treatment options, participating in the trial does not pose an increased risk or burden with regards to the treatment. Performing tracheobronchoscopies may pose a potential burden. However, a tracheobronchoscopy is a routine diagnostic procedure commonly used to safely assess the trachea. Complications of a tracheobronchoscopy are rare. Also, many of the tracheobronchoscopies are routinely performed as part of standard care for these patients, regardless of the trial.

NCT ID: NCT06322680 Not yet recruiting - Clinical trials for Pancreaticoduodenectomy

Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy

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

Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. However, the postoperative complication rate remains high at 25%-50%, limiting the development and application of PD. The main postoperative complications of PD are postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and biliary leakage (BL). POPF, BL, and the subsequent abdominal infection, PPH, etc. are the main causes of death during hospitalization. Even in large, relatively mature pancreatic centers, the incidence of POPF remains as high as 10%-40%. In recent years, various methods have been used to prevent and treat POPF and BL after PD, such as pancreatic duct stent external drainage and external biliary drainage. To date, there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence, mortality rate, etc., but the research results are not consistent. Overall, pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD. Currently, there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula. For example, a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al. found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula. However, due to the low level of evidence, only a few risk factors such as pancreatic texture and pancreatic duct diameter were included, and the risk of POPF was not systematically evaluated. Further clinical exploration and verification are needed. In 2013, Mark P Callery et al. proposed a pancreatic fistula risk score (The fistula risk score, FRS) based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group, which included pancreatic texture, pathological type, pancreatic duct diameter, and intraoperative blood loss. This model can be used to systematically and quantitatively evaluate the risk of POPF. Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage, which may have included too many patients with a low risk of pancreatic fistula, resulting in inaccurate results. Therefore, it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type. At the same time, pancreatic juice contains a variety of digestive enzymes, of which pancreatic lipase, trypsin, and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein. Theoretically, biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients. Thus, the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication, especially POPF.

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: NCT06297343 Not yet recruiting - Renal Failure Clinical Trials

Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula

MODIFVASC
Start date: May 2024
Phase:
Study type: Observational

The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.

NCT ID: NCT06198400 Not yet recruiting - Pancreatic Fistula Clinical Trials

Indocyanine Green Fluorescence in Evaluation of Pancreatic Remnant Perfusion.

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

Main goal of this study is to evaluate the blood flow in a post resection pancreatic remnant after pancreaticoduodenectomy with use of indocyanine green fluorescence. If the hypothesis will be proven, evaluation of perfusion of the pancreatic remnant with indocyanine green could be used to estimate the increased risk of the development of pancreatic fistula.

NCT ID: NCT06141044 Not yet recruiting - Drainage Clinical Trials

Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy

PANDREAS
Start date: January 2024
Phase: N/A
Study type: Interventional

Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.

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: NCT06099015 Not yet recruiting - Portal Hypertension Clinical Trials

Cera™ Vascular Plug System Post-Market Clinical Follow-Up

Start date: June 2024
Phase:
Study type: Observational

The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: - confirm the performance - confirm the safety - identify previously unknown side-effects - monitor the identified side-effects (related to the procedures or to the medical devices) - identify and analyse emergent risks