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Anastomotic Leak clinical trials

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NCT ID: NCT06049758 Not yet recruiting - Blood Loss Clinical Trials

D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy

Start date: January 2, 2024
Phase: N/A
Study type: Interventional

Evaluating the differences between D2 and D3 lymphadenectomy in laparoscopic right hemicolectomy in patients with right cancer colon post-operative outcome, intra-operative blood transfusion, post-operative ICU admission, anastomotic leakage, lymph node harvesting in the final specimen, and six months follow up and overall survival time after 5-years

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: NCT05987787 Completed - Clinical trials for Bariatric Surgery Candidate

Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy

Start date: January 1, 2022
Phase:
Study type: Observational

Staple line reinforcement (SLR) has been suggested as a mean of reducing the risk of sleeve leakage or bleeding. The aim of this study is to analyze if the suture reinforcement can be used to reduce the leakage rate after sleeve gastrectomy.

NCT ID: NCT05981937 Completed - Anastomotic Leak Clinical Trials

ICG Anastomosis Control in Colon Surgery

Start date: July 20, 2023
Phase:
Study type: Observational

This is a parallel monocentric, retrospective cohort study in Guglielmo da Saliceto Hospital, Piacenza, Italy. Aim of this study is to investigate the protective role of Indocyanine green (ICG) for Anastomotic leak (AL) in patients underwent elective segmentary colic resection (transverse colic resection, left colectomy including sigmoidectomy, splenic colic flexure resection). Secondary aims are to detect and to investigate the impact of various risk factors on AL and morbidity and surgical performance within 30 days to surgery.

NCT ID: NCT05957562 Completed - Leak, Anastomotic Clinical Trials

Azygos Vein Preservation; Its Impact on Early Outcomes After Neonatal EA/TOF Repair

EArAzygousvp
Start date: April 10, 2020
Phase: N/A
Study type: Interventional

Azygos vein preservation revisited: impact on early outcomes after repair of Esophageal atresia/ Tracheo-Esophageal Fistula in newborns. A randomized controlled study.

NCT ID: NCT05945654 Not yet recruiting - Swallowing Disorder Clinical Trials

Functional Outcome After Anastomotic Leak After Oesophagectomies

FOAL
Start date: September 1, 2023
Phase:
Study type: Observational

The main surgical treatment for oesophageal cancer is a curative resection, mostly performed according to Ivor Lewis. However, despite careful work and refined surgical techniques, anastomotic leakage (AL) occurs in more than 1/10 of the patients. This severe complication normally requires immediate intervention, while over the last 10 years, endoscopic vacuum therapy (EVT) has become the crucial therapy for broken-down anastomosis. The hypothesis is that despite suffering a severe complication, the subjective swallow function is not impaired in patients treated by EVT after an anastomotic leak, compared to patients without AL.

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.