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Anastomotic Leak clinical trials

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NCT ID: NCT04518384 Completed - Anastomotic Leak Clinical Trials

Risk Factors Associated With Anastomotic Leak and Perioperative Mortality in Elderly

Start date: August 6, 2017
Phase:
Study type: Observational

This is a retrospective cohort study of all consecutive patients who underwent colon or rectal resection, between the years 2012-2017 at Rabin Medical Center, a tertiary referral center in Israel. Data were obtained from patients' electronic medical files. The study was approved by the Institutional Review Board (IRB) of Rabin Medical Center (RMC). The study met the guidelines outlined in the Declaration of Helsinki. Due to the minimal risk nature of this study, the need for informed consent was waived by the IRB. Patient population: All patients aged 70 years and above who underwent large bowel resection were included in the analysis. Inclusion criteria were: age ≥70; all patients undergoing any colonic or rectal resection for benign or malignant etiologies in an open or minimally-invasive approach Exclusion criteria were: age<70; colon resection without anastomoses; re-operations during the same admission . Data retrieved included demographic data (age, gender, Charlson comorbidity score, place of residency, functional capacity, BMI), surgical data (indication for surgery, elective vs urgent surgery, surgical approach, length of surgery, peri-operative morbidity and mortality.All surgeries were performed by at least one senior surgeon. The surgical approach (laparoscopic or laparotomy) was at the senior surgeon's discretion and deemed most appropriate for the patient's problem, physiological status and underlying illnesses. The extent of the resection was according to oncological guidelines when relevant Endpoints: Primary endpoint was the occurrence of postoperative anastomotic leak. Secondary end-point was postoperative mortality Statistical Analysis The statistical analysis for this paper was generated using SAS Software. Continuous variables were presented by Mean±Std, Categorical variables were presented by (N, %). T-Test was used to compare the value of continuous variables between study groups and Fisher's exact test (for two groups) or Chi-square (for more than two groups) were used to compare the value of categorical variables between study groups. Two-sided p values less than .05 were considered statistically significant

NCT ID: NCT04512326 Enrolling by invitation - Total Colectomy Clinical Trials

RISK FACTORS FOR ANASTOMOTIC LEAKAGE FOLLOWING TOTAL OR SUBTOTAL COLECTOMY (RIALTCOT)

RIALTCOT
Start date: August 10, 2020
Phase:
Study type: Observational

Higher anastomotic leakage (AL) rate is reported after ileosigmoid (ISA) or ileorectal anastomosis (IRA) in total or subtotal colectomy (TSC) compared to colonic or colorectal anastomosis. An AL reduction in these cases may improve short and long terms outcomes significantly. Current evidence remains insufficient to assess AL risk after TSC, based on single-center studies or small cases series. The investigators aim to analyse and identify potential risk factors to AL following TSC and ISA or IRA, both preoperative and intraoperative in order to prevent surgical complications. The study is set up as a retrospective multicentre observational study. Inclusion criteria are patients (1) over 18 years old, (2) underwent restorative TSC with ISA or IRA anastomosis, (3) with/without loop ileostomy (4) between 2013-2019. Exclusion criteria are: (1) non-restorative TSC, (2) previous colorectal resection, (3) deferred anastomosis in trauma surgery and (4) other surgical resection in the same procedure. AL will be defined as a defect of the integrity of the intestinal wall at the anastomotic site leading to a communication of the intra and extraluminal or a pelvic abscess adjacent to the anastomosis according to the definition set by de International Study Group of Rectal Cancer. AL requiring no active therapeutic intervention will be classified as Grade A. AL requiring active therapeutic intervention (antibiotics and percutaneous drainage) but manageable without relaparotomy will be classified as Grade B and AL requiring re-intervention were classified as Grade C. Multivariable logistic regression model will be used in order to assess potential AL risk factors. p value <0,05 will be consider to indicate statistical significance. Primary outcome is to assess potential risk factors to AL after restorative (ISA or IRA) TSC. Secondary outcomes are to identify risk factors to associated postoperative morbidity, mortality and re-admissions. Data will be collected in each participating center enrolled in the study by the assigned principal investigator, confidentially and codified. Data will be sent to the study principal investigator. Database, patients code and email address will be provided at the study inclusion.

NCT ID: NCT04490668 Completed - Gastric Cancer Clinical Trials

Human Albumin and Anastomotic Leakage After Gastric Cancer Surgery

Start date: January 1, 2016
Phase:
Study type: Observational

We investigate whether the intravenously administered human albumin is beneficial to prevent anastomotic leakage after gastric cancer surgery.

NCT ID: NCT04462354 Active, not recruiting - Clinical trials for Pancreatic Neoplasms

Pancreatic Anastomosis After Duodenopancreatectomy

PANGASBLUM
Start date: June 4, 2020
Phase: N/A
Study type: Interventional

A national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart anastomosis).

NCT ID: NCT04422106 Recruiting - Anastomotic Leak Clinical Trials

Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores

Start date: June 17, 2020
Phase: N/A
Study type: Interventional

Aim of the work This study aims at; Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leakage with application of scoring scale to assess presence or absence of leakage.

NCT ID: NCT04418739 Recruiting - Pancreatic Cancer Clinical Trials

Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

Start date: January 27, 2020
Phase: Phase 2
Study type: Interventional

Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes are broadly categorized to disease-related, patient-related and operative factors. Whereas an inexhaustible list of study exists on looking at reducing PD complication rates with respect to the above-mentioned factors, it was only recently that more attention has been given to the impact of perioperative and intraoperative fluid regimes on PD outcomes. This study takes interest in the impact of intraoperative fluid regimes on PD outcomes. The objective of this investigation is to compare the outcomes with the use of intraoperative intravenous human albumin versus standard intraoperative fluid regimes.

NCT ID: NCT04386148 Completed - Clinical trials for Anastomotic Leak Rectum

Impact of Obsidian ® ASG on Anastomotic Healing

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

The use of regenerative medicine in colorectal surgery constitutes an entirely new therapeutic principle. The aim of this new therapeutic approach is to reduce the anastomotic leak rate and minimise morbidity and mortality. The literature identifies the leak rate for colorectal operations as 3-39%.

NCT ID: NCT04362605 Completed - Clinical trials for Anastomotic Leak Esophagus

Endoscopic Negative Pressure Therapy After Oncological Gastrectomies

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Background and study aims: Management of esophago-jejunal anastomotic leackages (EJAL) after gastric resections is challenging. Endoscopic negative pressure therapy (ENPT) is an emerging effective tool for treatment of gastrointestinal and anastomotic leaks. We use ENPT for EJAL after oncological gastric resections as first line therapy since 2018. The aim of the study was to present our results with this strategy by a case series. Patients and methods: Eight patients were treated with ENPT for EJAL after oncological gastric resections between 01.2018 and 12.2019. A retrospective analysis of patient's and therapy related data was performed. Results: Time of detection was 6.25 ± 2.54 days after surgery. After 15.63 ± 9.92 days of ENPT, 6.43 ± 3.66 endoscopies and 38.75 ± 17.35 days of hospitalization, endoscopic treatment with ENPT combined with minimal-surgery for sepsis-control was effective in seven of eight patients. In one patients treatment was changed to Stent-based therapy combined with further surgical interventions. Conclusions: ENPT is one step in the complication management of patients with anastomotic insufficiencies after oncological gastric resections. It can be recommended in combination with minimal invasive surgery for sepsis-control. Success of ENPT for EJAL seams to be dependent on the age and size of the insufficiency and the clinical situation of the patient.

NCT ID: NCT04319835 Completed - Ischemia Clinical Trials

Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy

Start date: April 25, 2016
Phase: N/A
Study type: Interventional

Postoperative surveillance of local metabolism of the surgical reconstruction after esophagectomy by means of Microdialysis. Dialysate is collected continuously for seven postoperative Days. Results analysed in a blinded fashion and related to the clinical outcome. Primary endpoint: anastomotic leakage

NCT ID: NCT04292496 Completed - Gastric Cancer Clinical Trials

Anastomotic Leak Testing in Gastrectomy

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group.