View clinical trials related to Anastomotic Leak.
Filter by:RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer. PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.
Phase III clinical trial to evaluate the efficacy of the open abdomen as bridging therapy to perform transit reconstruction in patients with anastomotic dehiscence. It is a randomized controlled single-center study that will be carried out at the Virgen del Rocío University Hospital in Seville.
To prospectively study the effect of adherence to ERAS and PBM programs on early outcomes after colorectal surgery
A prospective and analytical study on the detection of early anastomotic leakage by abdominal drainage fluid after colorectal cancer surgery. pay attention to indicators including bilirubin
Endoscopic negative pressure therapy (ENPT) is a safe technique, showing promising results in the treatment of leakages of the upper and lower gastrointestinal tract. The purpose of this study is to determine the safety and efficacy of ENPT in the management of proximal staple line leak after sleeve gastrectomy.
Anastomotic insufficiency remains one of the most significant problems after rectal resection.The complications following anastomotic insufficiency leads to increased morbidity and mortality with subsequent prolongation of hospital stay and higher costs. This study is an investigation of the benefit of using an autologous platelet-rich fibrin matrix (Obsidian ASG®) for treatment of anastomosis during rectal surgery - a single-blind, randomized, multicenter pilot study with enrollment of 2x220 patients The main objective of the study is to investigate on an exploratory basis whether the use of Obsidian ASG® during rectal resection reduces the frequency of postoperative anastomotic insufficiency compared to standard anastomotic technique. The secondary objectives of the study are to investigate on an exploratory basis: - The frequency of anastomotic insufficiency (ISREC Criteria) severity - Staple line bleeding requiring surgical intervention - The duration of postoperative hospitalization are reduced when using Obsidian ASG ® compared with standard anastomotic treatment alone. are reduced when Obsidian ASG ® is added to the standard of anastomotic treatment compared with standard anastomotic treatment alone.
Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world and the third in France. Its incidence is steadily rising in developing nations. Anastomotic leak (AL) is a major problem in colorectal surgery affecting at least 7% of patients operated on for left colonic cancer. It is the most feared complication after colorectal anastomosis, associated with mortality, prolonged hospitalization, impaired health related quality of life (HRQoL) and increased health care costs. Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) may help preventing AL. Available studies on the effects of IOFA with ICG are heterogeneous and randomized controlled trial are scarce. Our aim is to demonstrate that IOFA with ICG could lead to a reduction of AL rate after left-sided or low anterior resection with anastomosis for CRC. The FLUOCOL-1 study is the first national, multicenter, single blind, randomized, 2-arm, phase III superiority clinical trial. The primary endpoint is the occurrence of an AL 90 days post-operation. AL is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer. The study population will be made of adult patients with left-sided or high rectal cancer scheduled to undergo elective left colectomy or high rectal resection (by open, laparoscopy or robotic surgery) and with expected stapled or hand-sewn intraperitoneal anastomosis. The exclusion criteria are mainly an emergent surgery; rectal cancer requiring total mesorectal excision and anastomosis expected below the peritoneal reflection; CRC requiring total or subtotal colectomy; CRC requiring transverse colectomy; recurrent CRC and locally advanced colorectal cancer requiring multi-visceral excision. A total of 1010 patients will be necessary (39 patients in each centre during 36 months). An interim analysis for efficacy and futility is scheduled when half of the participants will have been recruited. In case of positive results favoring IOFA, this study would define the use of IOFA as a standard of care in colorectal surgery. At the patient level, a significantly lower rate of AL will reduce hospital stay and stoma rate, and will ensure improved postoperative recovery, faster return to normal activity and better long-term oncologic outcomes.
Aim of this study is to implement the intestinal microbiota by perioperative administration of probiotics, oral antibiotics and low volume mechanical preparation in order to reduce the incidence of colorectal anastomotic leaks and dehiscences.
The interest in identifying a biological marker for the early detection of AL is growing. Such a marker could play a vital role in modern fast-track multimodal protocols, allowing safe and early discharge of patients after colorectal surgery with a low rate of readmission. C-reactive protein (CRP) has been identified as a valid parameter for detection of postoperative infectious complications after rectal resection. A serum CRP level greater than 12.4 mg/dL on postoperative day (POD) 4 is considered predictive of septic complications. According to a recent analysis, the changes in the trajectory of CRP levels might be more beneficial than a snipped point. Moreover, the trajectory has a negative predictability of up to 99.3%. Another interesting biomarker is procalcitonin (PCT), the prohormone of calcitonin, produced by parafollicular C cells in the thyroid. Normally, it has a very low plasma concentration in healthy individuals (0.01-0.05 ng/mL), and it increases during severe generalized bacterial, parasitic, or fungal infections, but not in noninfectious inflammatory reactions. Procalcitonin has been described as an early, sensitive, and specific marker of sepsis. Moreover, the plasma concentration of PCT has been used as an early predictor of infection in acute pancreatitis, secondary peritonitis, and infectious complications after thoracic, esophageal, and cardiac surgeries. In addition, elevated white blood cell (WBC) count is associated with AL after gastrointestinal surgeries. Therefore, this study was conducted to evaluate the utility of CRP, PCT, and WBC count trajectories, as separate and combined biomarkers for prediction of AL after colorectal surgery.
Fluorescence angiography with indocyanine green (ICG-FA) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage. While qualitative ICG assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, ICG dose and white-light contamination). The alternative is quantitative ICG assessment, which is performed by evaluating the time-intensity curve of the ICG-FA with an external analyzing software. The procedure is showing promising results, but the methodology is still reported very heterogeneously. This study is a multi-center, prospective, standardized, surgeon-blinded observational trial. The key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the ICG perfusion measurement, providing no chance of influencing the course of the operation. Assessment of perfusion will be performed postoperatively blinded to the outcome. Assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. The primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.