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Anastomotic Leak clinical trials

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NCT ID: NCT05753709 Completed - Ileus Clinical Trials

Conventional Hand Sewn End-To-End Anastomosis Versus Side-To-Side Anastomosis for Stoma Reversal: A Prospective Study

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

The goal of this clinical trial is to compare approaches to enterostomy reversal by hand-sewn end-to-end anastomosis versus side-to-side anastomosis (sub-divided into hand-sewn side-to-side anastomosis and stapled side-to-side anastomosis). The main question it aims to answer is: • If either of the approaches are better than the other with respect to success rates, efficacy, post-operative complications and overall morbidity. Participants admitted for stoma reversal will be divided into two groups: 1. EE: Conventional Hand-sewn end-to-end anastomosis, and 2. SS: Side-to-side anastomosis, which will be further divided into 2 sub-groups: 1. HSSA: Hand-sewn side-to-side anastomosis 2. SSSA: Stapled side-to-side anastomosis Researchers will compare the EE group to SS group overall, and a second comparison will be made between EE, HSSA and SSSA groups, to see: 1. Rates of major post-operative complications 2. Rates of short-term complications (within 30 days of surgery) 3. Rates of re-operation 4. Post-operative length of stay in the hospital

NCT ID: NCT05725967 Enrolling by invitation - Obesity Clinical Trials

Endoscopic Metabolic and Bariatric Therapies

EMBTs
Start date: July 8, 2022
Phase:
Study type: Observational [Patient Registry]

This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.

NCT ID: NCT05713955 Withdrawn - Clinical trials for Anastomotic Leak Esophagus

OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

Start date: January 9, 2024
Phase: N/A
Study type: Interventional

Multicentre randomized controlled trial to evaluate the effectiveness of an autologous BioMatrix on a circular stapled esophagogastric anastomosis after Ivor Lewis esophagectomy.

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.

NCT ID: NCT05646290 Recruiting - Gastric Cancer Clinical Trials

Validation of a Model for Predicting Anastomotic Leakage

Start date: January 6, 2022
Phase:
Study type: Observational

This study will validate a machine learning model for predicting anastomotic leakage of esophagogastrostomy and esophagojejunostomy.

NCT ID: NCT05643105 Enrolling by invitation - Colon Cancer Clinical Trials

Anastomotic Leakage After Colon Cancer Surgery

ANACO II
Start date: December 15, 2022
Phase:
Study type: Observational [Patient Registry]

Anastomotic leak (AL) is one of the most feared complications after colon cancer (CC) surgery. The incidence varies according to the studies, the definition used and the location of the excised segment. In some of the series described, AL incidence have hardly changed, despite the evolution of the technique and technological improvements. The leak rate obtained in the only Spanish prospective multicenter observational study at national level was 9% (ANACO study). The aim of the present study is to determine the current rate of AL in our country, 10 years after the ANACO study, to determine if there has been any evolution and to analyze the factors associated with it. For this purpose, AL is defined with the same criteria as in the first study, as leakage of luminal contents through the junction between two hollow visceras, diagnosed radiologically (radiography with soluble enema or CT with collection adjacent to the anastomosis), clinically (extravasation of luminal contents or gas through the wound or drainage), endoscopically or intraoperatively. To compare AL rates throughout this decade, a 60-day follow-up will be performed, the same as in the ANACO study. As a modification respect to the ANACO study protocol, the aim is to analyze the possible influence of AL and perioperative intra-abdominal infection on short-term oncologic prognosis, with a one-year follow-up. This question has hardly been studied in prospective multicenter studies to date. The variables to be collected are divided into demographic (information about the hospital center, patient comorbidities), diagnostic variables (analytical values, diagnostic reason, neoadjuvant, localization, TNM), surgical variables (type of surgery, preparation, intention, intraoperative findings and complications, type of resection and anastomosis), admission (AL, other complications), histology, 60-day follow-up (AL, readmissions), one-year follow-up (readmissions, local recurrence, peritoneal and distant recurrence). Patients included in the study must be >18 years old undergoing oncologic surgery for CC located 15 cm above the anal margin, with preoperative histological confirmation or with endoscopic suspicion of infiltrating lesion or with radiological suspicion in the context of urgent surgery. Intestinal continuity (anastomosis) should be reconstructed and a derivative stoma should not be associated in the same surgery. According to ANACO data and follow-up times according to the primary objective (AL) at 60 days and the secondary objective (oncologic prognosis) with annual follow-up, inclusion will be carried out until the 1628 individuals required according to the sample size calculation performed are included.

NCT ID: NCT05627934 Not yet recruiting - Anastomotic Leak Clinical Trials

Quantification of Anastomostic Blood Flow With Fluorescence Imaging in Low Anterior Resection for Rectal Cancer

FILAR
Start date: March 1, 2023
Phase:
Study type: Observational [Patient Registry]

A serious and life-threatening complication to rectal surgery is anastomotic leakage, AL. In Denmark, approximately 800 patients every year, are operated for rectal cancer, 50% of these with resection and anastomosis. The registered leakage rate for rectal anastomosis is 10-15%. AL can be life threatening and has long-term adverse effects for the patients, with reduced quality of life, due to a poor functional result of the neo-rectum known as low anterior rectal syndrome (LARS). Fistulas to the vagina or urinary tract are other severe complications. Furthermore, AL is associated with an increased risk of reccurence1. Finally, the AL-associated morbidity is also a significant economic burden to the health care system due to prolonged hospital stay, medicine, and reoperations. During surgery it is important to ensure optimal healing conditions for the anastomosis. The blood flow is evaluated by colour and pulsation in the mesentery. Studies suggest that it might be easier to evaluate the perfusion using fluorescent dye. This evaluation is a subjective evaluation, based mostly on the surgeon's experience. Assessing fluorescence by computer-based software, qICG, has been developed. But cut-off values for sufficient blood flow to diminish the risk of leakage, has not yet been defined. Aim: Primary objective: To establish cut-off values of qICG, where blood flow assumes sufficient for healing, and thereby reduce the risk of leakage. Secondary objective: To identify which long-term complications grade A, B and C leakages entails on Quality of Life.

NCT ID: NCT05610904 Not yet recruiting - Clinical trials for Anastomotic Leak Rectum

Evaluation of AL Prediction for Rectal Cancer

Start date: December 10, 2022
Phase: N/A
Study type: Interventional

Anastomotic leakage is one of the most serious postoperative complications of low rectal cancer, with an incidence of 3%-21%. The occurrence of anastomotic leakage is related to many factors, and the occurrence of anastomotic leakage can be predicted by building a prediction model. Most of the anastomotic leakage prediction models constructed in the past are nomograms, which have limitations in the fitting of model creation. In the previous study, the center took the lead in building a random forest anastomotic leakage prediction model based on machine learning. This study intends to prospectively enroll patients with rectal cancer undergoing anterior abdominal resection and use their clinical data to prospectively verify the efficacy of the anastomotic leakage prediction model, and further improve and promote the prediction model.

NCT ID: NCT05606822 Recruiting - Anastomotic Leak Clinical Trials

Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

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

The goal of this observational study is to learn about the best indications and techniques regarding endoscopic vacuum therapy (EVT) in patients with a transmural defect in the upper gastrointestinal (GI) tract (e.g. anastomotic leakage, Boerhaave syndrome, iatrogenic perforation, other). The main questions it aims to answer are: - What is the success rate of EVT for transmural defects in the upper GI tract? - What are the best indications for EVT in the upper GI tract? (e.g. etiology, patient characteristics, defect characteristics) - What are the best techniques for EVT in the upper GI tract? (e.g. EsoSponge, VACStent, vacuum pressure, intraluminal/intracavitary) Participants will be asked for informed consent to retrospectively and prospectively collect data on EVT.

NCT ID: NCT05579912 Completed - Anastomotic Leak Clinical Trials

The Diagnostic Dilemma of Anastomotic Leak in Esophagogastric Surgery

Start date: November 28, 2019
Phase:
Study type: Observational

To study the diagnostic specificity and sensitivity of various modalities used for the assessment of anastomotic leak in esophagogastric surgery and to identify the most sensitive technique. Secondarily, to propose a clinical algorithm to guide clinicians in the diagnosis of anastomotic leaks esophagogastric surgeries.