Clinical trials: Anastomotic Leakage
Colorectal Disease Requiring Elective Laparoscopic Resection, Colorectal Anastomotic Leak
ICG Fluorescence Angiography to Reduce Anastomotic Leak After Laparoscopic Colorectal Resection
This prospective randomized controlled trial evaluates whether intraoperative indocyanine green (ICG) fluorescence angiography reduces clinically significant anastomotic leakage after elective laparoscopic colorectal resection…
- Trial name
- NCT07826156
- Testing
- Visual assessment, ICG visuals assessment
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Alexandria University
Rectal Cancer Patients
Preoperative Nasal Intestinal Obstruction Catheter Mediated Terminal Ileum Fecal Diversion Versus Intraoperative Protective Ileostomy for Preventing Anastomotic Leakage After Mid Low Rectal Cancer Surgery: A Non Inferiority, Prospective, Multicenter Randomized Controlled Trial
We are currently conducting a multicenter randomized controlled clinical trial entitled *Preoperative Nasal Placement of Bowel Obstruction Catheter for Terminal Ileum Fecal Diversion versus Intraoperative Protective Ileostomy in…
- Trial name
- NCT07821437
- Testing
- Preoperative oral placement of bowel obstruction catheter
- Volunteers
- 500 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract
The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis…
- Conditions
- C.Surgical Procedure; Digestive System, Symptomatic Disorders of the Gastrointestinal Tract, Gastric Anastomosis (Site), Gastrointestinal Neoplasms
- Trial name
- PROMEGAT (NCT02080702)
- Testing
- Monosyn
- Where
- 5 sites in Malaysia, Philippines and 2 more
- Volunteers
- 106 people
- Sponsor
- Aesculap AG
Colorectal Surgery, Anastomotic Leak Rectum
VACStent Use for the Treatment of Anastomotic Leakage Following coloREctal Surgery
Introduction: Anastomotic leakage (AL) is the most severe complication following colorectal surgery and is associated with significant morbidity and mortality.
- Conditions
- Colorectal Surgery, Anastomotic Leak Rectum, Endoscopy, Digestive System, Vacuum Therapy
- Trial name
- VACURE (NCT07631702)
- Testing
- VacStent GI Colon device
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- Amsterdam UMC, location VUmc
Esophageal Neoplasms
Nutritional Route In Esophageal Resection Trial II
The aim of this study is to investigate the effects of early start versus delayed start of oral intake on postoperative functional recovery after an esophagectomy.
- Trial name
- NUTRIENTII (NCT02378948)
- Testing
- Liquid oral feeding
- Where
- 2 sites in Netherlands
- Volunteers
- 148 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
Anastomotic Leak, Anastomotic Leak Large Intestine
A1Check: the External Validation of a Machine Learning Model Predicting Colorectal Anastomotic Leakage
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.
- Conditions
- Anastomotic Leak, Anastomotic Leak Large Intestine, Anastomotic Complication, Anastomotic Leak Rectum
- Trial name
- A1Check (NCT05810207)
- Testing
- Colorectal resection
- Where
- 8 sites in Netherlands
- Volunteers
- 1,000 people
- Sponsor
- Freek Daams
Esophageal Anastomotic Leak
Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage (PLACE030)
The primary objective is to evaluate the efficacy and assess the role of Porcine Fibrin Sealant (Bioseal®) in preventing cervical anastomotic leakage after esophagectomy in the patients with resectable thoracic esophageal cancer…
- Trial name
- NCT03847857
- Testing
- Porcine Fibrin Sealant (PFS), McKeown esophagectomy
- Where
- 6 sites in China
- Volunteers
- 360 people
- Sponsor
- Sun Yat-sen University
Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight
The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication
This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition / "dual-path" procedure) in…
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Obesity & Overweight, Marginal Ulcer (Peptic) or Erosion, Leakage, Anastomotic
- Trial name
- MACBIPARTFCG (NCT07495020)
- Testing
- Laparoscopic transit bipartition with Metallic Anastomotic Clip and Circular Fundocorporeal Gastroplication, Laparoscopic transit bipartition (gastroenteroanastomosis and entero-enteric anastomosis) use the Metallic Anastomotic Clip and with sleeve gastrectomy, laparoscopic duodenal transit bipartition using the Metallic Anastomotic Clip with circular fundocorporeal gastroplication without gastrectomy
- Where
- Kazakhstan
- Volunteers
- 90 people
- Sponsor
- The Society of Bariatric and Metabolic Surgeons of Kazakhstan
User-Centered Design, Anastomotic Leak
Evaluating the Effective and Safe Use of Stream™ Platform
The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform.
- Conditions
- User-Centered Design, Anastomotic Leak, Colorectal Surgery, Artificial Intelligence
- Trial name
- Home-Stream (NCT06522061)
- Testing
- Stream™ Platform
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- FluidAI Medical
Ulcerative Colitis, Ileal Pouch
MRI Anastomotic Integrity of Pelvic Intestinal Anastomoses
This protocol describes using an MRI-Enema technique to assess the integrity of colorectal anastomoses when compared to fluoroscopic water soluble contrast enema, and provides information the participant recruitment process…
- Conditions
- Ulcerative Colitis, Ileal Pouch, Anastomotic Leak
- Trial name
- NCT04719169
- Testing
- Dynamic MRI enema, Fluoroscopic enema
- Where
- United Kingdom
- Volunteers
- 16 people
- Sponsor
- London North West Healthcare NHS Trust
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, Colorectal Cancer
The Prediction of Anastomotic Insufficiency Risk After Colorectal Surgery (PANIC) Study
The Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study aims to establish a machine-learning-based application that allows for accurate preoperative prediction of patients at risk for anastomotic…
- Conditions
- Anastomotic Leak, Colorectal Cancer, Diverticulosis, Crohn Disease
- Trial name
- NCT04985981
- Where
- 2 sites in Switzerland
- Volunteers
- 11,000 people
- Sponsor
- Michel Adamina, MD
Anastomotic Leak, Anastomotic Haemorrhage
THREE-row Circular STAPLER in Low Anterior Resection for Rectal Cancer
This trial aims to assess safety and efficacy of three-row circular staplers compared to two-row surgical stapllers in short-term and long-term perspective in patients with rectal cancer undergoing low anterior resection with…
- Conditions
- Anastomotic Leak, Anastomotic Haemorrhage, Anastomotic Complication, Rectal Neoplasms
- Trial name
- THREESTAPLER (NCT03910699)
- Testing
- Three-row circular stapler, Two-row circular stapler
- Where
- Russia
- Volunteers
- 154 people
- Sponsor
- Russian Society of Colorectal Surgeons
Anastomotic Leak
Spanish National Registry of ANAstomotic Leakage in CAncer of the REctum (ANACARE)
Primary Endpoint: The main objective of this National Registry is to identify the incidence and to analyse the risk factors for anastomotic leakage in rectal cancer surgery From the operational point of view, the aim of this…
- Trial name
- ANACARE (NCT02634112)
- Volunteers
- 2,000 people
- Sponsor
- Hospital Universitario La Fe
Rectal Neoplasms
Defunctioning Cannula Ileostomy After Lower Anterior Resection of Rectal Cancer
Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing anterior resections.
- Trial name
- NCT01980238
- Testing
- cannula ileostomy, loop ileostomy, LAR
- Where
- China
- Volunteers
- 300 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
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
Colorectal Cancer, Anastomotic Leak
Indocyanine Green Fluorescent Imaging in Robotic Assisted Rectosigmoidal Resection; a Multicenter Assessment of Interobserver Variation and Comparison With Computer-based Pixel Analysis
A serious complication to colorectal surgery is anastomotic leakage (AL). AL increases post-operative mortality, decreases long-term survival, reduces the functional result and reduces qual-ity of life.
- Trial name
- NCT04766060
- Testing
- Fluorescent Imaging
- Where
- Denmark
- Volunteers
- 55 people
- Sponsor
- Odense University Hospital
Gastric Cancer, Gastrostomy
Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.
- Conditions
- Gastric Cancer, Gastrostomy, Anastomotic Leakage, Postoperative Complications
- Trial name
- NCT06464978
- Testing
- Stapler Reinforcement Patch, Standard Stapler
- Where
- China
- Volunteers
- 382 people
- Sponsor
- Nanchong Central Hospital
Gastrointestinal Cancer, Colorectal Cancer
Microbiome Analysis in esoPhageal, PancreatIc and Colorectal CaNcer Patients Undergoing Gastrointestinal Surgery
The MA-PPING is a multicenter prospective observational study that includes patients undergoing surgery for gastrointestinal cancer.
- Conditions
- Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Cancer, Esophageal Cancer
- Trial name
- MA-PPING (NCT04189393)
- Volunteers
- 60 people
- Sponsor
- Radboud University Medical Center
Esophageal Cancer
Tissue Oxygenation Are Associated With Anastomotic Leak Rates After an Ivor Lewis Esophagectomy
The purpose of this study is to test whether after an Ivor Lewis esophagectomy (the removal of a portion of the stomach and esophagus with re-attachment) there is an association between the intraoperative level of oxygen at the…
- Trial name
- NCT01551433
- Testing
- wireless pulse oximeter (Wipox)
- Where
- United States
- Volunteers
- 166 people
- Sponsor
- Memorial Sloan Kettering Cancer Center