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Anastomotic Leak clinical trials

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NCT ID: NCT02718729 Completed - Anastomotic Leakage Clinical Trials

Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer

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

Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and esophageal anastomosis than the other parts of the alimentary tract due to technical difficulties in accessing these areas and their easily compromised blood supply. Anastomotic leakage is the most feared complication following rectal resection and anastomosis. The incidence of anastomotic leakage ranges from 2.8% to more than 15%, with mortality rate more than 30%. Subclinical anastomotic failure may occur in up to 51% of patients. Anastomotic leakage leads to increase the rate of secondary interventions, re-operations, longer postoperative hospital stay, increased cost, and major impact on the patient's quality of life. In the medium to long term, patient may be unfit for post-operative adjuvant therapy with decreased the disease survival. Furthermore anastomotic leakage itself may increase the local recurrence, a reduction in overall survival, and a large proportion of patients are left with a permanent stoma.

NCT ID: NCT02703142 Completed - Clinical trials for Esophageal Neoplasms

Endoscopic Evaluation After Esophagectomy

Start date: October 2015
Phase: N/A
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.

NCT ID: NCT02686567 Completed - Rectal Neoplasms Clinical Trials

Use of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer

Start date: February 2016
Phase: N/A
Study type: Interventional

The rate of anastomotic leakage after laparoscopic anterior resection(LAR) for medium & low rectal cancer is still high. the transanal drainage tube (TDT) was thought to be useful for deduce the rate. There were several studies, but most of them were not randomized controlled trial (RCT) studies. There was only one RCT study with enough samples, but it was designed for open anterior resection, and the patients underwent diverting stoma were excluded, so there was the selection bias. LAR now is thought to been with the same effect, and it is safe and feasible. So a RCT investigation for the use of TDT for prevention of anastomotic leakage after LAR for medium & low rectal cancer is needed.

NCT ID: NCT02459405 Completed - Anastomotic Leak Clinical Trials

Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging

Start date: March 2013
Phase: Phase 2
Study type: Interventional

Anastomotic leak is a devastating complication of colorectal surgery. There is no widespread means of assessing the viability of a laparoscopic anastomosis. The investigators described recently the feasibility of microvascularisation assessment with near-infra red technology (NIR). The aim of this study is to look at the implementation of this technique in a wider prospective series of patients undergoing colorectal resection.

NCT ID: NCT02432794 Completed - Clinical trials for Esophageal Anastomotic Leak

Trial on Delay Phenomenon Utility in Preventing Anastomotic Leakage After an Esophagectomy

APIL_2013
Start date: May 2015
Phase: N/A
Study type: Interventional

This is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. The delay phenomenon will be performed by an arteriographic approach.

NCT ID: NCT02401100 Completed - Anastomotic Leak Clinical Trials

Anastomotic Leakage After Anterior Resection for Rectal Cancer - Predictive Biomarkers and Rectal Blood Flow

Start date: May 2015
Phase:
Study type: Observational

The purpose of this study is to determine whether reduced rectal blood flow is associated with the extent of surgery when performing an operation to remove rectal cancer. The investigators also aim to describe any relation of reduced rectal blood flow, as well as raised inflammatory biomarkers in blood and tissue, to the occurrence of anastomotic leakage. The patients will be recruited at Umeå University Hospital and all patients who are planned to undergo anterior resection for rectal cancer and able to consent are eligible for this study. Rectal blood flow measurements will be conducted with Laser-Doppler technology using noninvasive measuring probes. Preoperative and postoperative blood sampling as well as postoperative drain fluid collection will take place. Perianastomotic tissue will also be collected. In the postoperative period, any occurrence of surgical complications especially anastomotic leakage, will be noted. Blood flow and biomarkers will be assessed in relation to type of mesorectal excision (total or partial) and correlated to anastomotic leakage. Standard statistical tools will be utilized, such as parametric, non-parametric tests and logistic regression, as appropriate. The study will recruit approximately 40 patients during three consecutive years.

NCT ID: NCT02361918 Completed - Clinical trials for Anastomotic Leakage in Colon Surgery

Predictive Value of Procalcitonin, CRP, Drain Fluid Culture, Il-6 and Tnf-α in Anastomotic Leakage

Start date: March 2012
Phase: N/A
Study type: Observational

Evaluating predictive value of serum procalcitonin, C-Reactive Protein, drain IL-6 and TNF-alpha for anastomotic leakage in post-operative period.

NCT ID: NCT02347735 Completed - Colorectal Cancer Clinical Trials

Predictive Factors for Anastomotic Leakage After Colorectal Surgery

REVEAL
Start date: August 2015
Phase:
Study type: Observational

Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide, estimated to be responsible for almost 610,000 deaths in 2008. Surgery remains the predominant curative treatment type for colorectal cancer, but has a major impact on the patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the development of frequently observed and severe postoperative complications. The most important complication after colorectal surgery is anastomotic leakage (AL), which has an incidence of 8-15% in the Netherlands. AL is associated with high short-term mortality rates of up to 40%. Even though many attempts have been made to reduce the incidence of this dreaded complication, none of these interventions have been successful so far. Despite proper patient selection and improvement in surgical techniques, the percentage of AL has been stable for years. Objectives: To investigate whether recently identified patient-specific factors can predict the occurrence of anastomotic leakage in patients undergoing elective surgery for colorectal cancer. Study design: Prospective observational study Study population: Adult colorectal cancer patients undergoing elective surgery. Main study parameters/endpoints: Primary endpoint: AL within 30 days postoperatively Secondary endpoints: Intestinal microbiome in fecal sample, I-FABP, SM22, Calprotectin, C-reactive protein(CRP), Citrullin, complement factors in blood, VOCs in exhaled air, COX-2 & MBL polymorphisms in buccal smear, L3-index & atherosclerosis measurements on CT-scans, SNAQ & MUST scores

NCT ID: NCT02178228 Completed - Anastomotic Leaks Clinical Trials

Observational Analysis of the Cause of Leaks When Bowel is Cut and Reconnected

Start date: October 2013
Phase: N/A
Study type: Observational

The purpose of this study is to identify the cause of leaks that sometimes occur after a section of the bowel is removed and reconnected. Certain staplers from the operating room will be collected and sent to a third party (ECRI Institute) to be examined for defects. The patient's charts will be analyzed for medical issues that may contribute to leaks after surgery.

NCT ID: NCT02175979 Completed - Anastomotic Leak Clinical Trials

SANICS II Trial: Stimulation of the Autonomic Nervous System in Colorectal Surgery by Perioperative Nutrition

SANICSII
Start date: August 2014
Phase: N/A
Study type: Interventional

The main objective is to investigate the effects of perioperative nutrition on postoperative ileus and anastomotic leakage in patients undergoing colorectal surgery. Perioperative enteral nutrition is compared to the standard of care (fasting perioperatively).