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Fistula clinical trials

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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: NCT05136859 Recruiting - Clinical trials for Arteriovenous Fistula

Inflammatory Marker and Pre-existing Venous Fibrosis to Predict AVF Mal-maturation

Start date: December 11, 2021
Phase: N/A
Study type: Interventional

End-stage renal disease patients needs a functional vascular access to receive hemodialysis and prolong their lives. Arteriovenous fistula (AVF) is priority consideration for hemodialysis, which is a connecting a superficial vein to a nearby artery and allowing this vein to enlarge and increase in internal diameter under arterial circulation. Unfortunately, 30-50% of fistulae fail to mature. Vascular calcification and stenosis were considered for early failure. The perivascular fat of artery can be predicted successful AVF maturation. However, Few previous studies have compared AVF maturation between perivascular the fat of cephalic vein or removal during the AVF surgery. This study evaluated whether the effect of AVF inflammation and preexisting vascular fibrosis is associated to perivascular the fat of cephalic vein. Investigators will also verify inflammation by analysis of blood and tissue samples, the association of pre-existing fibrosis, and the clinical correlation with AVF early failure. This study will enroll patients with chronic kidney disease stage 5 and stage 6 who will need maintenance-hemodialysis (HD) from Nov 2021 to Dec 2022. Investigators will use the preoperative ultrasound assessment tool to confirm the feasibility of the arm vessels for the creation of a native AVF. As a prospective randomized controlled trial of perivascular fat preservation or removal during the AVF surgery, a study assistant will help the randomization and explain the informed consent to the patient . The subjects are randomly split into two groups: the experimental group will have the perivascular fat of the target cephalic vein preserved the control group will have the fat removed before the AVF anastomosis. The survey will enroll 100 adult patients and categorize them into groups according to each AVF maturation, JAS, or FTM (see definition below) by 3 - 12 after the 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: NCT05132712 Recruiting - Clinical trials for Vascular Access Complication

Effects of Angiotensin Converting Enzyme Inhibitors on Patency of Arterio-Venous Fistulas: A Randomized Controlled Trial

Start date: October 1, 2021
Phase: Early Phase 1
Study type: Interventional

Chronic kidney disease (CKD) is one of the leading health problems imbibing a major portion of health budget worldwide. The global prevalence of CKD is estimated to be 13.4% with approximately 5 to 7 million people needing renal replacement therapy. There is lack of epidemiological surveys regarding CKD but it is estimated to be around 5% and nearly half of them are diabetic. In Pakistan most of the patients undergo hemodialysis as mode of renal replacement as renal transplant centers are few and over burdened. Therefore, a good vascular access for hemodialysis is vital for CKD patients. A functioning arterio-venous fistula (AVF) improves quality of life and morbidity. However, access failure remains a major problem in patients of CKD accounting for third most common cause of admission. There are various options for attaining vascular access but AVF remains the most reliable with less morbidity and better overall patency rate. However, the AVF has its own limitation and has overall patency rate of 50-70% at 1 year and 30-40% at 2 years. This outcome indicates that strategies to prevent occlusion by altering modifiable risk factors are suboptimal and warrant further research. Patients of CKD often have associated cardiovascular diseases as Ischemic heart disease, left ventricular failure and angina. They are often taking cardio-protective medicines as antiplatelets, angiotensin converting enzymes and calcium channel blockers. Intimal hyperplasia has been shown to be the most important cause of AVF failures.2 Angiotensin II promotes vascular smooth muscle proliferation through various growth factors. Various experimental models have clearly depicted that ACE inhibitors effectively stop smooth muscle growth and intimal hyperplasia in vessel walls. Literature review shows conflicting results in terms of AVF patency when ACE inhibitors are used in conjunction. A study by Jackson RS and colleagues showed that ACE inhibitor were associated with reduced hazard ratio [HR], 0.35; 95% confidence interval [CI], 0.16-0.76; P = .008). Whereas, another study showed no role of ACE inhibitors in preventing graft failure. The possible explanation can be study designs as most studies were retrospective and effects of possible confounders. Moreover, there is lack of research in Pakistan to see the effects of pharmacological drugs on primary patency of AVF among CKD patients. The rationale of this study is to effectively establish the role of ACE inhibitors in achieving primary patency of AV fistulas while reducing the number of confounders. This will be the first randomized controlled trial conducted in Pakistan. The primary outcome is AVF patency at one year. Secondary outcomes will include graft complications and graft maturation time after surgery.

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: NCT05116072 Recruiting - Clinical trials for Adenocarcinoma of the Pancreas

Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula

TPIAT-01
Start date: February 20, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Curative management of locally resectable invasive adenocarcinomas located in the cephalic region of the pancreas (pancreas, duodenum and ampulla of Vater) requires a pancreaticoduodenectomy followed by adjuvant chemotherapy. Pancreaticoduodenectomy is a major surgery that often leads to major complications including approximately 20% of relevant clinical postoperative pancreatic fistula. Postoperative complications following pancreaticoduodenectomy can lead to early discontinuation of the complete oncologic strategy, i.e., chemotherapy for malignancy is performed in only about a third of patients who experienced a grade C fistula. A total pancreatectomy rather than a pancreaticoduodenectomy is an alternative procedure that involves the complete and definitive resection of all pancreatic tissue, eliminating any risk of postoperative pancreatic fistula but is associated with unavoidable endocrine insufficiency and potentially severe metabolic complications, such as "brittle diabetes". Total Pancreatectomy following by intraportal Islet AutoTransplantation (TPIAT) can prevent "brittle diabetes" and improve the quality of life. The endocrine islets can be isolated from the pancreatic surgical specimen with standardized procedures and transplanted in the liver through intraportal infusion, in absence of immunosuppression and allow adequate control of glucose metabolism with a reduced need for exogenous insulin and an effective graft function in 70% of cases at 3 years Thereby, the investigators hypothesize that total pancreatectomy with intraportal Islet autotransplantation rather than classical pancreaticuduodenectomy, in patients with high-risk of postoperative fistula will increase the rate of complete access to adjuvant chemotherapy, while maintaining an adequate metabolic control.

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: NCT05088083 Not yet recruiting - Clinical trials for Arteriovenous Fistula

Paclitaxel-Coated Balloon for the Treatment of AVF

AVF
Start date: December 2021
Phase: N/A
Study type: Interventional

To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.

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: NCT05082792 Enrolling by invitation - Clinical trials for Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic Monitoring

The Role of Doppler Ultrasound in Assessment of Local Factors Affecting Maturation of Arteriovenous Fistula in Hemodialysis Patient

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

the long term survival of the chronic kidney disease (CKD) patients depends on the adequacy of dialysis via good vascular access. the arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis. pre-operative evaluation and periodic monitoring of the AVF after creation with well-defined applied criteria by color doppler ultrasound (CDUS) will help to reduce rate of access failure and achieve better cumulative patency rate of fistulas.