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Anastomotic Leak clinical trials

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NCT ID: NCT06348381 Recruiting - Anastomotic Leak Clinical Trials

Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation

Start date: April 1, 2024
Phase:
Study type: Observational

Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. Analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury.

NCT ID: NCT06273826 Recruiting - Clinical trials for Anastomotic Leak Rectum

"Colorectal Leakage App" for Early Detection of Anastomotic Leakage After Colorectal Surgeries

Start date: January 19, 2024
Phase:
Study type: Observational [Patient Registry]

The aim of this prospective observational study is to evaluate the effectiveness of the mobile application "Colorectal Leakage App" in the early diagnosis of anastomotic leakage after colorectal surgeries at the National Research Oncology Center in Astana, Kazakhstan. Main Questions: 1. Development, validation, and implementation of the mobile application "Colorectal Leakage App," based on the Dutch Leakage Score. 2. Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries. 3. Determine the frequency of anastomotic leakage after colorectal surgeries performed in the colorectal surgery sector of the National Research Oncology Center in the Astana city. Participants in the study, individuals aged 18 and above undergoing colorectal surgeries, will be monitored by the mobile application "Colorectal Leakage App" in the postoperative period for early identification of anastomotic leakage.

NCT ID: NCT06155175 Recruiting - Anastomotic Leak Clinical Trials

Risk of NSAIDs on Anastomotic Leak for Rectal Surgery

Start date: May 1, 2023
Phase:
Study type: Observational

Conflicting reports of the association between early postoperative non-steroidal anti-inflammatory drugs (NSAIDs) administration and anastomotic leak (AL) after rectal surgery have continued. The definition of AL and the exposure of NSAIDs differ from each other among studies, which may result in the different conclusions. The aim of this retrospective study was to clarify the effect of NSAIDs on anastomotic leak from new angels.

NCT ID: NCT06136845 Recruiting - Esophageal Tumors Clinical Trials

The Correlation Between Microbiome of Esophageal Cancer Patients and Post Esophagectomy Anastomotic Leaks

microbiome
Start date: January 13, 2020
Phase:
Study type: Observational

Esophageal cancer continues to be one of the most challenging topics and the subjects of numerous studies. Surgery is the mainstay for curative treatment and the need to improve all aspects of perioperative management in order to reduce morbidity and mortality, continues to be of immense importance. Cited as the sixth most common cause of cancer-related death worldwide, esophageal cancer has a distinct geographic distribution known as the esophageal cancer belt: north central China through the central Asian republics to northern Iran, and from eastern to southern Africa. Squamous-cell carcinoma and adenocarcinoma are the two main histological subtypes of esophageal cancer, in a geographic differentiation as well, with squamous-cell carcinoma as the most common esophageal cancer subtype worldwide. Though adenocarcinoma is at a considerable rise in Western populations and has become the predominant subtype North America, Australia and Europe. Although an ongoing improvement has been marked in the long-term survival after esophagectomy, it is still a highly invasive procedure with serious post-operative complications and entails a high morbidity and mortality rates. Rates of mortality and morbidity range vastly in the literature with 30-day mortality reaching 11-22%. Complication rates up to 50%, with anastomotic leaks as the main complication ranging widely 0-35%. Various risk factors have been proposed as contributors to mortality and morbidity in general and to anastomotic leaks in particular. These include both patient and tumoral characteristics such as premedical history and perioperative factors as tumor location, surgical technique and perioperative treatment. The microbiome as a contributor to a patients' disease progression and management is of great interest in the understanding and better management of cancer patients as a whole and of the gastrointestinal tract in specific. The contribution of the microbiome of a patient to colorectal cancer progression and to anastomotic leaks in the post-operative period has been addressed vastly in the literature in recent years, showing a distinct correlation to specific microbiota profile. Shogan et al. depicted a potential molecular mechanism of bacterial-driven anastomotic leak. It was shown that strains of the commensal organism Enterococcus faecalis could cause anastomotic leakage by causing direct collagen degradation at the site of a freshly constructed anastomosis, and indirectly by bacterial-induced over activation of host matrix metalloproteinase 9 (MMP9). A geographic differentiation in microbiota of Colorectal Cancer (CRC) was also shown by comparing tumor tissue and adjacent tissue of Colorectal Cancer patients from the US and Spain, elaborating yet another aspect of the importance of microbiome of cancer patients. Oropharyngeal microbiome profiling has been proven as a possible predictor for post esophagectomy pneumonia projecting on overall survival as well. A recent study by Rishindra et al from the university of Michigan shows a strong correlation of post esophagectomy anastomotic leaks and increased bacterial variance in preoperative oral and gastric flora. We hypothesize that a correlation exists between microbiome of esophageal cancer patients and post esophagectomy anastomotic leaks. According to former evidence microbiota are integrated into the tumor and therefore the microbial profile of the host (patient) may be represented by tumor microbiota. In this proposed study, we intend to characterize retrospectively the microbial signature of esophageal tumors and to study whether there is a correlation between differential microbial signature and risk of post esophagectomy anastomotic leaks.

NCT ID: NCT05994625 Recruiting - Anastomotic Leak Clinical Trials

Economic Evaluation of Stream™ Platform

CostAL
Start date: December 6, 2023
Phase: Phase 3
Study type: Interventional

This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional trial. The purpose of this study is to evaluate the economic and patient outcomes of using the Stream™ Platform for early detection of anastomotic leakage after gastrointestinal surgery. The trial will track patient outcomes and healthcare costs in two groups: the intervention group, where the Stream platform is deployed, and the control group, before the integration of the Stream™ Platform. The data collected from both groups will be compared to assess the impact of implementing the Stream™ Platform and early leak detection on overall patient outcomes and healthcare costs.This trial will include hepatobiliary, colorectal, and trauma/acute care patient populations.

NCT ID: NCT05943444 Recruiting - Quality of Life Clinical Trials

Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer

Start date: August 8, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life. The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.

NCT ID: NCT05942209 Recruiting - Gynecologic Cancer Clinical Trials

ECO-LEAK Technique: Early Detection of Colorectal Anastomotic Leakage by Transvaginal Ultrasound

Start date: April 17, 2023
Phase:
Study type: Observational [Patient Registry]

The main hypothesis is that anastomotic leakage can be predicted peri- and postoperatively.To this end, the aim is to establish the accuracy of transvaginal ultrasound with transrectal enema (Ecoenema-TV) for the diagnosis of anastomotic leakage in patients undergoing colorectal anastomosis. diagnosis of anastomotic leakage in patients undergoing colorectal anastomosis.

NCT ID: NCT05810207 Recruiting - Anastomotic Leak Clinical Trials

A1Check: the External Validation of a Machine Learning Model Predicting Colorectal Anastomotic Leakage

A1Check
Start date: February 1, 2022
Phase:
Study type: Observational [Patient Registry]

Anastomotic leakage is a severe complication that can arise following a colorectal resection. It impairs both the short- and long-term outcomes, and negatively influences cancer recurrence rates. Its detrimental effects resound in healthcare costs of a patient after anastomotic leakage, €71,978, versus patients with an uncomplicated course, €17,647. Despite multiple innovations within the field of colorectal surgery, the incidence of colorectal anastomotic leakage did not reduce in the past decade. Mitigation strategies such as prehabilitation, intraoperative optimization, selective bowel decontamination, and reconstruction techniques are promising but do not completely eliminate the risk of leakage. The only true prevention of colorectal anastomotic leakage is the omission of an anastomosis and implies an ostomy, which in itself has a negative impact on the quality of life. A stoma is associated with stoma-related morbidity and should, therefore, be avoided in patients who do not need it. Predicting anastomotic leakage intra-operatively, just before the construction of the anastomosis, may offer a solution. A stoma will then only be constructed in those at high risk of anastomotic leakage. Currently, there are prediction models for anastomotic leakage based on conventional multivariate logistic regression analysis, however, these are not useful for clinical practice due to suboptimal results. Machine learning algorithms, on the other hand, take well into account the multifactorial nature of complications and might thus be able to predict anastomotic leakage more accurately. The machine learning model we created proved to be well capable of making accurate predictions. This model was developed based on a database containing both pre- and intra-operative data from 2,483 patients. Before these models can be used in daily practice, external validation is essential. Our models should be tested on unseen data from patients treated in centers that were not previously involved in the database that was used to train the model in order to achieve high reproducibility. Our hypothesis is that with our model, we can accurately predict anastomotic leakage intra-operatively during colorectal surgery.

NCT ID: NCT05779254 Recruiting - Clinical trials for Microbial Colonization

SURGIcal COmplication and MIcrobiome ChangeS in Colorectal Surgery

Surgi-Comics
Start date: February 1, 2023
Phase:
Study type: Observational

The microbiome, the collection of microorganisms that live in our gut, plays an important role in maintaining our health, proper nutrient absorption, nutrient turnover and immunity. After birth, a symbiotic relationship develops with the strains of bacteria that colonise our gut, and the presence and proportion of bacteria is individualised and highly variable. A healthy bacterial flora is essential for the cells of the intestinal mucosa. Glycoproteins in the cell surface mucus coat are important nutrients for bacteria, while some bacterial strains supply mucosal cells with nutrient molecules (e.g. short-chain fatty acids) that are their essential energy source. An abnormal change in the proportion of bacterial strains that make up the microbiome, dysbacteriosis, in which pathogenic bacteria proliferate at the expense of members of the normal flora, can cause a number of pathologies. Nutrient supply to the cells of the mucosa is reduced, making them more vulnerable and leading to various pathological conditions. The microbiome and the essential nutrients they produce have also been found to play an important role in wound healing. A decrease in the diversity of the microbiome, an increase in the relative number of pathogenic bacteria and a decrease in the proportion of 'beneficial' bacteria increases the risk of surgical complications of infection and suture failure.

NCT ID: NCT05667181 Recruiting - Rectal Cancer Clinical Trials

The Application Value of da Vinci Linear Cutting Stapler SureForm in Robotic Anus Preserving Surgery for Rectal Cancer

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

Anastomotic complications are serious complications after anus preserving surgery for rectal cancer,the instrument anastomosis technology are one of the factors that influence the occurrence of anastomotic complications after surgery,the laparoscopic linear cutting closure device used in robotic rectal cancer may increase the occurrence of anastomotic complications,but the robot linear cutting stapler (SureForm) may reduce the incidence of postoperative anastomotic complications due to the technical advantages,therefore,the aim of this study is to evaluate the impact of robotic linear cutting stapler SureForm and laparoscopic linear cutting stapler on the incidence of anastomotic complications after robotic rectal cancer anus preserving surgery.