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Anastomotic Leak clinical trials

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NCT ID: NCT05606822 Recruiting - Anastomotic Leak Clinical Trials

Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to learn about the best indications and techniques regarding endoscopic vacuum therapy (EVT) in patients with a transmural defect in the upper gastrointestinal (GI) tract (e.g. anastomotic leakage, Boerhaave syndrome, iatrogenic perforation, other). The main questions it aims to answer are: - What is the success rate of EVT for transmural defects in the upper GI tract? - What are the best indications for EVT in the upper GI tract? (e.g. etiology, patient characteristics, defect characteristics) - What are the best techniques for EVT in the upper GI tract? (e.g. EsoSponge, VACStent, vacuum pressure, intraluminal/intracavitary) Participants will be asked for informed consent to retrospectively and prospectively collect data on EVT.

NCT ID: NCT05579912 Completed - Anastomotic Leak Clinical Trials

The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery

Start date: November 28, 2019
Phase:
Study type: Observational

To study the diagnostic specificity and sensitivity of various modalities used for the assessment of anastomotic leak in esophagogastric surgery and to identify the most sensitive technique. Secondarily, to propose a clinical algorithm to guide clinicians in the diagnosis of anastomotic leaks esophagogastric surgeries.

NCT ID: NCT05502354 Recruiting - Rectal Cancer Clinical Trials

CRP-guided Transanal Drainage Removal After Rectal Surgery

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Previously, TDT was removed at the surgeon's own discretion. In the present study, we design a single arm study to investigate the safety and efficacy of CRP-guided TDT removal for AL prevention following laparoscopic anterior resection for rectal carcinoma

NCT ID: NCT05476159 Completed - Surgery Clinical Trials

Indocyanine Green Test in Bariatric Surgery

Start date: January 1, 2020
Phase:
Study type: Observational

Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time

NCT ID: NCT05411783 Recruiting - Colorectal Cancer Clinical Trials

Low Tie Versus High Tie of the Inferior Mesenteric Vein During Colorectal Cancer Surgery: A Randomized Clinical Trial

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

This study aim to determine if a different surgical technique could result in a lower anastomotic leak rate. The two techniques are equally used around the world and well described by the international literature but this is the first study that compare the two techniques.

NCT ID: NCT05390684 Enrolling by invitation - Gastric Cancer Clinical Trials

Predictive Model to Early Diagnosis of Anastomotic Leak After Esophagectomy and Gastrectomy.

PROFUGO
Start date: May 1, 2022
Phase:
Study type: Observational [Patient Registry]

The PROFUGO study (PRedictive Model for the early diagnosis of anastomotic leak after esophagectomy and gastrectomy) is proposed as a prospective and multicenter study at spanish national level that aims to develop, with the help of artificial intelligence methods, a tool and predictive model that allows identifying cases with a high risk of anastomotic leak (AF) and/or major complications through the analysis of different clinical and analytical variables collected during the perioperative period of patients undergoing esophagectomy or gastrectomy. 2.-HYPOTHESIS Early identification of patients at high risk of developing AF and/or major complications after esophagogastric surgery can be carried out through the perioperative study of objective clinical variables and analytical markers. 3.-OBJECTIVE The main objective of the study is to design a predictive model based on clinical and analytical variables that allow the identification of patients with a high risk of anastomotic leak (main variable) and/or major complication during the postoperative period of esophagogastric surgery. 4.-MATERIAL AND METHODS - DESIGN: Prospective and multicenter study of 1 year duration. - STUDY POPULATION: Patients diagnosed with neoplasia of the esophagus or stomach with an indication for oncological surgery with curative intent. - INCLUSION CRITERIA: patients with surgical indication and curative intention due to esophagogastric neoplasm who do not meet exclusion criteria and recruited by hospitals nationwide that decide to participate in the study. - EXCLUSION CRITERIA - Patients under 18 or over 85 years - Patients with chronic infections - Patients with synchronous tumors in other locations - Patients with autoimmune disease - Patients who die in the operating room - Patients who do not sign the informed consent to participate in the study - Patients in clinical stage IVB - Surgical resection R2 (there are macroscopic remains of the tumor in the surgical field after performing the resection of the surgical piece) - Combined intraoperative resection of other organs - Surgeries without anastomosis - MONITORING: The patient will be monitored during the first 90 postoperative days. 5.-DURATION OF THE STUDY The time for the inclusion of patients in the study will be 1 year in each center from the incorporation of the first of their patients.

NCT ID: NCT05293054 Completed - Rectal Cancer Clinical Trials

Healing of Rectal Anastomosis Sealed With a Concentrate Derived From the Patient's Blood, After Rectal Cancer Surgery

OBANORES
Start date: December 15, 2021
Phase:
Study type: Observational

Rectal cancer is one of the most frequent cancer diseases, with more than 1500 new cases per year in Denmark. Fortunately, if the tumor is discovered early, surgeons can remove the part of the intestine that is afflicted, and they can often sew the intestine-ends back together, forming what is known as an anastomosis. However, in 10-15% of cases, this anastomosis doesn't heal completely, leading to anastomotic leakage. This is a serious complication, with detrimental effects for the individual patient. Previous measures to avoid this complication, have proven unsuccessful. Obsidian is a mixture derived from the patients' own blood, that contains components of blood normally responsible for stopping bleeding and kickstarting the healing process. It is already used in other clinical settings and preliminary, yet unpublished, results from a pilot study have shown its promise in decreasing the risk of anastomotic leakage in rectal anastomosis. However, its use has not been examined when performing surgery for rectal cancer with minimally invasive technique, which is today's standard. The main clinical hypothesis of this feasibility study is that it is possible for colorectal surgeons to apply Obsidian successfully on the anastomotic area with minimal invasive technique, as a supplement during rectal cancer resection with anastomosis. This study will be conducted at the Department of Surgery, Aarhus University Hospital. 50 patients will be included, who will undergo minimally invasive rectal cancer surgery with an anastomosis. Right after the onset of anaesthesia, 120 ml of blood will be collected from the patient and will be processed, making a 5-6 ml Obsidian concentrate. When the tumor-bearing part of the rectum has been removed, Obsidian will be applied, according to a pre-specified protocol. If the application is deemed successful (based on predefined assessment criteria) in at least 90% of our included patients, then this study will serve as a stepping stone for a bigger study, the aim of which will be to assess if this method can indeed bring down the rate of anastomotic leakage in such patients.

NCT ID: NCT05264467 Completed - Colorectal Surgery Clinical Trials

Leukocyte and and Platelet-rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis

Start date: March 12, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Anastomotic leak rate in colorectal surgery is estimated between 4 and 20 percent. Leukocyte and and platelet-rich fibrin plasma (L-PRF) is second generation platelet concentrate whose application in colorectal anastomosis in animals has shown promising results that suppose a lower leakage rate. The objective of this study was to assess the feasibility of using L-PRF in colorectal surgery and to determine the incidence of anastomotic leakage after colorectal anastomosis.

NCT ID: NCT05257863 Recruiting - Cancer Clinical Trials

Development of Machine Learning Models for the Prediction of Complications After Colonic, Colorectal and Small Intestine Anastomosis in Psychiatric and Non-psychiatric Patient Collectives (P-Study)

Start date: May 1, 2022
Phase:
Study type: Observational

Our study aims to lay the basis for a predictive modeling service for postoperative complications and prolonged hospital stay in patients suffering from psychiatric diseases undergoing colorectal surgery. Furthermore, we aim to investigate the impact of preoperative Risk factors, psychiatric and psychosomatic diseases on the outcomes of colorectal surgery and the complications after colorectal surgeries like anastomosis insufficiency via predictive modeling techniques The service mentioned above will be publicly available as a web-based application

NCT ID: NCT05250882 Active, not recruiting - Clinical trials for Intraoperative Awareness

Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage

DOUBLE CHECK
Start date: September 5, 2021
Phase: N/A
Study type: Interventional

This multicenter open-label trial is designed to evaluate if the implementation of an enhanced peri-operative care protocol results in an optimal intraoperative condition of the patient and in a decrease in incidence of anastomotic leakage after colorectal resection as compared to current practice.