Clinical trials: Leaks, Anastomotic
Anastomotic Leak
Economic Evaluation of Stream™ Platform
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…
- Trial name
- CostAL (NCT05994625)
- Testing
- Stream™ Platform, Stream™ Platform with Risk Score Omitted
- Where
- 2 sites in Canada
- Volunteers
- 215 people
- Sponsor
- FluidAI Medical
Rectal Cancer
SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak
The goal of this clinical trial is to learn whether using a reinforcing material called SIS (small intestinal submucosa) during bowel connection after rectal cancer surgery can help prevent anastomotic leakage-a serious…
- Trial name
- NCT07209787
- Testing
- SIS-reinforced anastomosis
- Where
- China
- Volunteers
- 966 people
- Sponsor
- Beijing Chao Yang Hospital
Postoperative Ileus, Anastomotic Leak
SANICS II Trial: Stimulation of the Autonomic Nervous System in Colorectal Surgery by Perioperative Nutrition
The main objective is to investigate the effects of perioperative nutrition on postoperative ileus and anastomotic leakage in patients undergoing colorectal surgery.
- Trial name
- SANICSII (NCT02175979)
- Testing
- enriched enteral nutrition, standard
- Where
- 5 sites in Denmark, Netherlands
- Volunteers
- 280 people
- Sponsor
- Misha D.P. Luyer
Colorectal Neoplasia, Anastomotic Leakage
Study on the Correlation Between Serum and Fecal Sialic Acid Levels and Tumor Characteristics as Well as Postoperative Anastomotic Leakage in Patients With Colorectal Tumors
This is a Single-center bidirectional cohort study combined with prospective sample analysis conducted by the Department of General Surgery at the Second Affiliated Hospital of Army Medical University (Xinqiao Hospital).
- Trial name
- NCT07189663
- Where
- China
- Volunteers
- 1,468 people
- Sponsor
- Xiaolong Li
Rectal Cancer
Transanual Tube Placement in Low Anterior Resection (LAR) for Rectal Cancer
The purpose of this study is to evaluate the effectiveness of transanual tube placement in low anterior resection (LAR) for rectal cancer in preventing anastomotic leakage.
- Trial name
- NCT02905968
- Testing
- transanual tube placement
- Where
- China
- Volunteers
- 520 people
- Sponsor
- Fudan University
Colorectal Surgery, Anastomotic Leak
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection
Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis.
- Trial name
- NCT06168669
- Testing
- xBar system
- Where
- 12 sites in United States, Israel
- Volunteers
- 222 people
- Sponsor
- Exero Medical Ltd.
Rectal Cancer
Selective sPlenic flExure Mobilization for Low colorEctal Anastomosis After D3 lYmph Node Dissection (Speedy Trial)
In the Low Anterior Resection of rectum for cancer, the section level of IMA and the need of SFM is still debated. The aim of this study is to explore the different impacts of high and low ligation with peeling off vascular…
- Trial name
- SpeeDy (NCT03895255)
- Testing
- Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization, Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization
- Where
- Russia
- Volunteers
- 142 people
- Sponsor
- Russian Society of Colorectal Surgeons
Anastomotic Leak, Esophageal Cancer
Assessment of Graft Perfusion and Oxygenation for Improved Outcome in Esophageal Cancer Surgery
After the esophagectomy, the stomach is most commonly used to restore continuity of the upper gastro-intestinal tract. The esophagogastric anastomosis is prone to serious complications such as anastomotic leakage (AL) The…
- Trial name
- EDOBS (NCT03587532)
- Testing
- Indocyanine green angiography, Hemodynamic evaluation, Biological and pathological markers of ischemia
- Where
- Belgium
- Volunteers
- 70 people
- Sponsor
- University Hospital, Ghent
Enterocutaneous Fistulas, Intra-abdominal Infection
Autologous Fibrin Glues for Fistulas Closure
Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output enterocutaneous fistulas. However, there are only few studies that report autologous glue application in a larger patient group or…
- Trial name
- NCT01561066
- Testing
- Autologous platelet-rich fibrin glue (PRFG), Octreotide
- Where
- China
- Volunteers
- 122 people
- Sponsor
- Jinling Hospital, China
TME, Rectal Cancer Surgery
REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department
The purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of…
- Conditions
- TME, Rectal Cancer Surgery, Low Rectal Cancer, Middle Rectal Cancer
- Trial name
- RELOAD (NCT07463261)
- Testing
- Without a preventive stoma, With a preventive stoma
- Where
- 7 sites in Russia
- Volunteers
- 442 people
- Sponsor
- ANO Scientific and Practical Club for the Development of Modern Medical Technologies
Bile Leak, Anastomotic Leak Biliary
Factors Influencing Occurrence of Bile Leaks in Surgery
The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.
- Conditions
- Bile Leak, Anastomotic Leak Biliary, Biliary Tract Fistula
- Trial name
- NCT04665427
- Testing
- bilioenteric anastomosis i
- Where
- Algeria
- Volunteers
- 108 people
- Sponsor
- University of Oran 1
Rectal Cancer, Anastomotic Leak Rectum
Volume-outcome Relationship in Rectal Cancer Surgery
Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery.
- Trial name
- NCT04761536
- Testing
- Rectal cancer case centralization
- Volunteers
- 187 people
- Sponsor
- University of Rome Tor Vergata
Anastomotic Leak
Use of NERv's Inline Device as an Early Diagnostic Method for Anastomotic Leak.
NERv's early feasibility clinical trial is a first-in-human, multi-center, pre-market, non-randomized clinical trial intended to evaluate the safety and collect preliminary data necessary for the detection of clinical…
- Trial name
- NCT04253028
- Testing
- NERv's Inline Device
- Where
- 2 sites in Egypt
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- FluidAI Medical
Genito Urinary Function Evaluation
Genito Urinary Function With High or Low Inferior Mesenteric Artery Ligation in Laparoscopic Anterior Rectal Resection
The aim of this study is to compare the incidence of genito-urinary function depression and anastomotic leak in Laparoscopic Anterior Rectal Resection (LAR) with Total Mesorectal Excision with Ligation if the Inferior Mesenteric…
- Trial name
- NCT02153801
- Testing
- During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .
- Where
- Italy
- Volunteers
- 212 people
- Sponsor
- Niguarda Hospital
Colorectal Surgery, Colorectal Resection
AUGUR-AI - Indocyanine Green Fluorescence Angiography Representer
Surgery can effectively treat colorectal cancer, but it is a complex procedure with risks and complications. Surgeons often rely on cameras to visually guide their instruments during operations, especially in minimally invasive…
- Conditions
- Colorectal Surgery, Colorectal Resection, Anastomosis, Surgical, Fluorescence Guided Surgery
- Trial name
- AUGUR-AI (NCT06708819)
- Where
- Ireland
- Volunteers
- 300 people
- Sponsor
- Mater Misericordiae University Hospital
Colorectal Cancer (CRC), Rectal Cancer Surgery
Indocyanine Green Fluorescence Angiography in Laparoscopic Sigmoid and Rectal Cancer Surgery
Anastomotic leakage remains a major complication after colorectal cancer surgery. Indocyanine green fluorescence angiography (ICG-FA) allows real-time intraoperative assessment of bowel perfusion; however, its clinical impact…
- Conditions
- Colorectal Cancer (CRC), Rectal Cancer Surgery, Sigmoid Colon Cancer
- Trial name
- NCT07423130
- Where
- Poland
- Volunteers
- 115 people
- Sponsor
- Jagiellonian University
Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine
Enhanced Perioperative Care for the Prevention of Colorectal Anastomotic Leakage
This multicenter open-label trial is designed to evaluate if the implementation of an enhanced peri-operative care protocol results in an optimal intraoperative condition of the patient and in a decrease in incidence of…
- Conditions
- Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine, Anastomotic Leak Rectum, Intraoperative Awareness
- Trial name
- DOUBLE CHECK (NCT05250882)
- Testing
- Enhanced perioperative care protocol
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 1,600 people
- Sponsor
- Amsterdam UMC, location VUmc
Esophageal Anastomotic Leak, Tissue Pressure of Oxygen
Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.
This study is a randomized clinical trial to clarify if preoperative embolization of gastric arteries can reduce the incidence of oesophagogastric leakage after an esophagectomy for esophageal cancer comparing an experimental…
- Trial name
- NCT04268654
- Testing
- Preoperative Arterial Embolization
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
Pancreatic Cancer, Pancreaticoduodenal; Fistula
Early Detection of Anastomotic Leakage by Microdialysis Catheters
Anastomotic leakage of the pancreatojejunostomy is often discovered with considerable delay, causing severe peritonitis, hemorrhage due to erosion of vessels, sepsis, and death.
- Conditions
- Pancreatic Cancer, Pancreaticoduodenal; Fistula, Pancreas; Fistula, Pancreatic Fistula
- Trial name
- NCT03627559
- Testing
- Pancreaticoduodenectomy microdialysis catheter analyses
- Volunteers
- 35 people
- Sponsor
- Oslo University Hospital
Anastomotic Leak
Fibrin Sealant in Esophageal Surgery
Anastomotic leakage remains a major complication after esophageal surgery. Amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques.
- Trial name
- SEAL (NCT03251040)
- Testing
- Autologous activated fibrin sealant
- Volunteers
- 15 people
- Sponsor
- Amsterdam UMC, location VUmc