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Anastomotic Leak clinical trials

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NCT ID: NCT05000580 Completed - Anastomotic Leak Clinical Trials

Colorectal Anastomotic Leak Management

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

Colorectal anastomotic leaks (AL) are associated with high morbidity and mortality. Management of AL and its intra-operative decision making is often difficult. The aim of this multi-centre study is to explore different management strategies, including different surgical options, and analyse rates and patterns of failure of initial management. All consecutive patients who had a confirmed AL after elective colorectal resections from 1st January 2014 to 31st December 2019 were included at seven hospitals across the East of England Region. Morbidity (length of stay, and failures) and mortality were compared across the different management strategies, and survival analyses were performed.

NCT ID: NCT04985981 Suspended - Colorectal Cancer Clinical Trials

The Prediction of Anastomotic Insufficiency Risk After Colorectal Surgery (PANIC) Study

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

The Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study aims to establish a machine-learning-based application that allows for accurate preoperative prediction of patients at risk for anastomotic insufficiency after colon and colorectal surgery.

NCT ID: NCT04973046 Completed - Clinical trials for Esophageal Neoplasms

Tissue Oxygen Saturation for Esophagectomy

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

Tissue oxygen saturation monitoring was a useful indicator of blood flow insufficiency in the gastric tube leading to anastomotic leakage during radical esophagectomy.

NCT ID: NCT04890015 Recruiting - Colorectal Cancer Clinical Trials

The Impact of Transanal Decompression Tube Placement After Colorectal Anastomosis: A Randomized Trial

SONDES
Start date: July 10, 2017
Phase: N/A
Study type: Interventional

There is currently no standardization in the use of the transanal decompressive tube during the postoperative after a colorectal surgery. The available evidence is based on studies with methodological differences. Most of the studies exclude patients with a diverting ileostomy, which are those patients who have a higher risk of anastomotic leak, so the real effect of transanal decompressive tube could have been masked. For this reason we believe that to assess the true effect of rectal decompression, patients with diverting stoma should be included.

NCT ID: NCT04846283 Completed - Anastomotic Leakage Clinical Trials

Drainage Fluid Biomarkers and Anastomotic Leakage in Colorectal Surgery. A Monocentric Prospective Observational Study

ALbiomarkers
Start date: June 1, 2018
Phase:
Study type: Observational

Anastomotic leakage (AL) is one of the most feared intra-abdominal septic complications (IASC) after colorectal surgery. It is defined as the leak of intestinal content due to an anastomotic dehiscence. Incidence ranges from 2% to 20%. AL is usually associated to systemic inflammatory response, even if in some cases the presentation may be subclinical. Therefore, AL is suspected in patients with a strong inflammatory response and can be confirmed by imaging with contrast enhanced computed tomography (CT) scan or water-soluble contrast studies. Nevertheless, imaging has varying sensitivity and specificity and is usually performed once the patient has a clinical evidence, thus potentially delaying the correct timing for surgery. Despite several studies about this topic and the plenty of known risk factors as mentioned above, AL is still not easy to predict. Different tools other than imaging have been studied in order to make diagnosis of AL at an early stage, as the measurement of some biomarkers of inflammation in serum and in drainage fluid. Biomarkers as white cell blood count (WBC), C-reactive protein (CRP), cytokines (e.g. TNFa, IL-6, IL-1b), markers of ischemia (e.g. lactate) and procalcitonin (PCT) have been used for an early detection of AL and other intra-abdominal septic complications. The primary aim of our study was to assess the role of drainage fluid CRP and lactate-dehydrogenase (LDH) in the early detection of anastomotic leakage.

NCT ID: NCT04783831 Recruiting - Pancreatic Cancer Clinical Trials

Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy

Start date: November 1, 2018
Phase:
Study type: Observational

Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. The use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications. Material and method: A single-center prospective randomized study was planned with patients undergoing PD. A duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum. The primary outcome of the study is the evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).

NCT ID: NCT04766060 Completed - Colorectal Cancer Clinical Trials

Indocyanine Green Fluorescent Imaging in Robotic Assisted Rectosigmoidal Resection; a Multicenter Assessment of Interobserver Variation and Comparison With Computer-based Pixel Analysis

Start date: April 1, 2017
Phase:
Study type: Observational

A serious complication to colorectal surgery is anastomotic leakage (AL). AL increases post-operative mortality, decreases long-term survival, reduces the functional result and reduces qual-ity of life. Studies suggest that performing an indocyanine-green enhanced fluorescent angi-ography (ICGeFA), blood perfusion in the bowel can be visualised. It is suggested that using this procedure the relative risk of AL is reduced about 54-67%. With this project we wish to evaluate the feasibility of the procedure, and, if proven feasible, to plan further studies evaluating the procedure.

NCT ID: NCT04761536 Completed - Rectal Cancer Clinical Trials

Volume-outcome Relationship in Rectal Cancer Surgery

Start date: January 2006
Phase:
Study type: Observational

Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. However, no linear relation between volume and outcome has been demonstrated. Aim of the study was to evaluate the increased surgical volume effect on early outcomes of patient undergoing restorative anterior rectal resection (ARR).

NCT ID: NCT04751149 Recruiting - Rectal Cancer Clinical Trials

Incidence of Acute Urine Retention: Randomized Clinical Trial Comparing Early, Mid or Late Urinary Catheter Removal in Patients With Rectal Resection

RAOREC
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

DESIGN: Randomized, open-label and parallel clinical trial, assigned to early, mid, or late withdrawal of urinary catheter with a 1: 1: 1 allocation ratio. POPULATION: Patients undergoing anterior rectal resection, low rectal resection, or abdominoperineal amputation for any reason. OBJECTIVES: The main objective is to compare the incidence of acute urine retention after removal of the urinary catheter in the postoperative period of rectal resection. Secondary objectives are: 1. Incidence of urinary tract infection after urinary catheter removal. 2. Incidence of specific postoperative complications (Surgical wound infection, Respiratory infection, Anastomotic dehiscence, ileus). 3. Incidence of postoperative complications assessed according to the Comprehensive Complication Index (CCI) scale. DESCRIPTION OF THE INTERVENTION: In all patients, a Rectal Resection (anterior rectal resection, posterior pelvic exenteration or abdominoperineal amputation) will be performed. In group 1A, the urinary catheter will be removed on the 1st postoperative day. In group 1B patients, the urinary catheter will be removed on the 3rd postoperative day. In group 1C patients, the urinary catheter will be removed on the 5th postoperative day. All patients will have a urine culture taken at the time of withdrawal.

NCT ID: NCT04739579 Completed - Crohn Disease Clinical Trials

Post-operative CRP Trend After Ileocolic Resection in Crohn's Disease Patients.

Start date: January 27, 2021
Phase:
Study type: Observational

Our aim is to analyze C-Reactive Protein trends during the post-operative course in Crohn's Disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis.