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Anastomotic Leak clinical trials

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NCT ID: NCT03529266 Completed - Esophageal Cancer Clinical Trials

Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma.

PLACE020
Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the efficacy and assess the role of Porcine Fibrin Sealant (Bioseal®) in preventing cervical anastomotic leakage after esophagectomy in the patients with resectable thoracic esophageal cancer and gastroesophageal junction cancer.

NCT ID: NCT03496441 Completed - Colorectal Cancer Clinical Trials

Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

Start date: January 30, 2018
Phase:
Study type: Observational

The study is based on the hypothesis that patients with postoperative anastomotic leakage have a different bacterial profile contributing to poor tissue healing, and that patients operated for colon cancer presumably have a different preoperative microbiota than healthy patients. This different composition is probably induced by the high heme level in the light intestinal tract that tumor spoliation generates. The objective of the study is to evaluate the feasibility of a larger study to evaluate the difference between microbiota composition of patients with and without colorectal cancer, with inflammatory bowel disease and those with and without anastomotic leakage postoperatively of a colonic resection. Stool samples will be taken from 20 patients, including 5 without intestinal pathology, 5 with colorectal cancer undergoing colorectal surgery, 5 with inflammatory bowel disease and 5 with anastomotic leakage after colectomy for colorectal cancer or inflammatory bowel disease. The stool samples will be analyzed at CRCHUM to draw up a profile of the bacteria that make up the microbiota of each patient.

NCT ID: NCT03325361 Recruiting - Rectal Cancer Clinical Trials

The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage

Start date: October 2017
Phase: N/A
Study type: Interventional

Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.

NCT ID: NCT03316677 Not yet recruiting - ColoRectal Cancer Clinical Trials

Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?

ITCORA
Start date: November 1, 2017
Phase: N/A
Study type: Interventional

A leak from a colorectal anastomosis is a post-operative complication surgeons fear the most, following colonic resection. Over the years, there have been multiple suggestions for intraoperative tests for the integrity of the colorectal anastomosis. Two of the most common tests that are performed routinely are: 1. Air tight leak test - filling the pelvis with saline and insufflating air trans anal - looking for air bubbles in the saline filled pelvis. 2. Injecting diluted dye (methylene blue) trans anal, and looking for blue dye stains on gauze pads covering the outer side of anastomosis. The aim of the study is to compare the two methods, and to assess if there is a superior method. A secondary aim is to establish standards to perform the test, mainly to assess the appropriate pressure to apply on the anastomosis. In this prospective study patients scheduled to undergo colonic resection of their distal part of the colon/ rectum with colorectal anastomosis, will have both testing methods performed sequentially and will be followed post-operative to assess the yield and sensitivity of the testing methods.

NCT ID: NCT03281070 Recruiting - Rectal Cancer Clinical Trials

Anastomotic Leakage After Anterior Resection of Rectal Cancer

Start date: October 1, 2017
Phase: N/A
Study type: Observational

Anastomotic leakage (AL) is one of the most-feared postoperative complications after anterior resection of rectal cancer. This complication compromises both short term and long term outcome of patients. The incidence of AL after anterior resection was approximately 6-11%. Although several risk factors for AL such as male sex, smoking, tumor location, longer operative time, intraoperative blood loss had been reported in previous studies, the incidence of AL did not meet a significant decrease. So far there is no multi-site observational study on incidence and risk factors of AL after anterior resection in China, therefore this study aims to work on this issue and provide evidence for clinical practice.

NCT ID: NCT03251040 Completed - Anastomotic Leak Clinical Trials

Fibrin Sealant in Esophageal Surgery

SEAL
Start date: August 1, 2015
Phase: N/A
Study type: Interventional

Anastomotic leakage remains a major complication after esophageal surgery. Amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques. The investigators aimed to investigate feasibility of additional sealing by means of autologous fibrin sealant of the esophageal anastomosis.

NCT ID: NCT03203434 Completed - Anastomotic Leak Clinical Trials

Non-invasive Detection of Anastomotic Leakage

Start date: January 1, 2015
Phase: N/A
Study type: Observational [Patient Registry]

Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with malignant tumors of the esophagus or pancreatic head. These procedures are associated with high morbidity rates, which are strongly correlated with the occurrence of anastomotic leakage. Current diagnostic methods, including clinical, biochemical and radiological techniques are frequently inconclusive. Delay in diagnosis leads to delay in treatment, which ratifies the need for development of novel and accurate non-invasive diagnostic tests for detection of anastomotic leakage. Urinary volatile organic compounds reflect the metabolic status of an individual, which is associated with a systemic immunological response. The aim of this study was to determine the diagnostic accuracy of urinary volatile organic compounds to detect anastomotic leakage after esophagectomy or pancreaticoduodenectomy in an early phase.

NCT ID: NCT03148054 Recruiting - Colon Disease Clinical Trials

Computed Tomography vs. Endoscopy Study

Start date: February 17, 2017
Phase:
Study type: Observational

Patients undergoing elective surgery for left-sided colon resection are asked to participate in this study: Every patient undergoes two types of examinations (endoscopy, CT scan) on day 3, 4 or 5 postoperatively. These two procedures are subject to investigation in terms of their accuracy (sensitivity, specificity) in detection of anastomotic leaks. The patients are followed up until day 42 postoperatively. There are no other specific tests or examinations within the study. Information and informed consent are obtained preoperatively.

NCT ID: NCT03131492 Completed - Anastomotic Leak Clinical Trials

Early Dehiscence Markers in Ovarian Cancer Surgery

EDMOCS
Start date: March 1, 2017
Phase:
Study type: Observational [Patient Registry]

EDMOCS trial pretends to evaluate if C-reactive protein (CRP) and procalcitonin (PCT) can predict intestinal anastomotic leaks before early discharge in advanced ovarian cancer surgery requiring intestinal resection. These markers have already been positively tested in colorectal cancer surgery, but not yet in ovarian surgery. Patients undergoing intestinal resection in ovarian cancer surgery will be included. C-reactive protein and PCT will be measured pre-operatively, and on the second, fourth and sixth postoperative day. Thirty-day readmissions, re-operations and mortality will be recorded.

NCT ID: NCT02937389 Completed - Clinical trials for Esophageal Neoplasms

Endoscopic Evaluation for Predicting the Complications Related to Gastric Conduit After Esophagectomy

Start date: May 2015
Phase:
Study type: Observational

Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.