Clinical trials: Leak, Anastomotic
Anastomotic Leaks, Hartmanns Stump Leakage
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
This study is intended to evaluate the safety and effectiveness of Sponge-based Endoscopic Vacuum Therapy (EVT) using Endo-SPONGE for the treatment of Anastomotic Leaks (AL) or Hartmann's stump leakages following colorectal…
- Trial name
- DRAIN Lower (NCT07035431)
- Testing
- Endo-SPONGE
- Where
- 10 sites in United States
- Volunteers
- 66 people
- Sponsor
- Boston Scientific Corporation
Leakage, Anastomotic, Colon Cancer
COLOFLOW: Laser Speckle Contrast Imaging Versus Near-infrared Fluorescence Imaging With Indocyanine Green
COLOFLOW is a prospective observational study investigating whether Laser Speckle Contrast Imaging (LSCI), a dye-free and objective perfusion imaging technique, corresponds with the currently used subjective assessment of…
- Conditions
- Leakage, Anastomotic, Colon Cancer, Colon Anastomosis, Colon and Rectal Cancer
- Trial name
- COLOFLOW (NCT07720505)
- Testing
- Laser Speckle Contrast Imaging
- Volunteers
- 30 people
- Sponsor
- Leiden University Medical Center
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
Gynecologic Cancers, Ovarian Cancer
Near-Infrared Fluorescence Imaging With Indocyanine Green to Evaluate Bowel Anastomoses in Gynecologic Oncology Surgery
The goal of this study is to evaluate if indocyanine green (ICG) fluorescence imaging helps reduce complications in bowel surgery performed during gynecologic cancer operations.
- Conditions
- Gynecologic Cancers, Ovarian Cancer, Endometrial Cancers, Cervical Cancers
- Trial name
- INOCA (NCT06871787)
- Testing
- Indocyanine Green, Near-Infrared Fluorescence Imaging System
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Istanbul University
Pancreaticoduodenectomy, Postoperative Pancreatic Fistula
Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate
This randomized controlled trial investigates the safety and efficacy of injecting N-butyl-2- cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the…
- Conditions
- Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Pancreas Cancer, Periampullary Cancer
- Trial name
- NBCA (NCT07230509)
- Testing
- Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group., Standard Pancreaticojejunostomy
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Minia University
Bowel Obstruction, Bowel Ischemia
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time points during procedures of…
- Conditions
- Bowel Obstruction, Bowel Ischemia, Diverticulitis, Abnormality of the Gastrointestinal Tract
- Trial name
- NCT04709445
- Testing
- ICG-NIRF Imaging plus ingress and egress analysis
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Charite University, Berlin, Germany
Liver Transplant; Complications, Bile Duct; Stricture, Postoperative
The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation
The main objective of the trial is to compare the effect of two end-to-end duct-to-duct anastomosis surgical techniques using the continuous suture method versus interrupted method (control group) on reducing the risk of bile…
- Conditions
- Liver Transplant; Complications, Bile Duct; Stricture, Postoperative, Bile Leak, Quality of Life
- Trial name
- NCT06533592
- Testing
- Continous suture technique, Interrupted suture technique
- Where
- Poland
- Volunteers
- 284 people
- Sponsor
- Medical University of Warsaw
Bariatric Surgery Candidate, Obesity, Morbid
Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy
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…
- Conditions
- Bariatric Surgery Candidate, Obesity, Morbid, Leak, Anastomotic, Bleeding
- Trial name
- NCT05987787
- Testing
- laparoscopic sleeve gastrectomy without suture reinforcement, laparoscopic sleeve gastrectomy with suture reinforcement
- Where
- Italy
- Volunteers
- 33 people
- Sponsor
- University of Foggia
Anastomotic Leak, Fistula
Use of NERv's Inline Device as an Early Diagnostic Method for Postoperative Complications
NERv's traditional feasibility clinical trial is a multi-center, pre-market, single-arm, and non-randomized trial. This study will involve the retrospective analysis of prospectively collected data.
- Conditions
- Anastomotic Leak, Fistula, Postoperative Leak, Postoperative Pancreatic Fistula
- Trial name
- NCT04582708
- Testing
- NERv's Inline Device
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 316 people
- Sponsor
- FluidAI Medical
Colorectal Cancer
Intraoperative Indocyanine Green Fluorescence Angiography in Colorectal Surgery to Prevent Anastomotic Leakage
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.
- Trial name
- FLUOCOL-1 (NCT05168839)
- Testing
- FLUO+ : Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG).
- Where
- 32 sites in France
- Volunteers
- 1,010 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Anastomotic Leakage, Rectal Neoplasms
Use of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer
The rate of anastomotic leakage after laparoscopic anterior resection（LAR） for medium \& low rectal cancer is still high. the transanal drainage tube (TDT) was thought to be useful for deduce the rate.
- Trial name
- NCT02686567
- Testing
- with TDT, without TDT
- Where
- China
- Volunteers
- 560 people
- Sponsor
- Third Military Medical University
Colorectal Surgery, Enhanced Recovery
CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery
In colorectal surgery, one of the most feared complications is anastomotic leak (AL). To limit the consequences of AL, it must be diagnosed as early as possible, before it becomes symptomatic.
- Conditions
- Colorectal Surgery, Enhanced Recovery, CRP Point-of-care Testing Trajectory, Post-operative Complication
- Trial name
- CRP (NCT07464600)
- Testing
- blood sample, Blood taken from a fingertip, Abdomino-pelvic CT scan
- Where
- France
- Volunteers
- 500 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Intestinal Anastomotic Leak
Risk Factors for Anatomic Leakage in Advanced Ovarian Cancer Surgery
Cytoreductive surgery is currently the main treatment for advanced epithelial ovarian cancer (AEOC), and the complete disease removal (RT=0) or the achievement of an optimal residual disease (RT < 1 cm) remain the factors with…
- Trial name
- NCT04604964
- Testing
- Evaluation of anastomotic leakage occurrence
- Where
- Italy
- Volunteers
- 515 people
- Sponsor
- Catholic University of the Sacred Heart
Rectal Cancer, Surgery Indication
Low Powered Colorectal Anastomosis After Rectal Excision (OASIS)
The objectiive of this prospective, international cohort is to compare two anastomotic techniques (DS vs TTSS) by collecting data during the surgery, and postoperatively (morbidity and functional outcomes).
- Trial name
- OASIS (NCT07146334)
- Where
- 15 sites in Belgium, Canada and 4 more
- Volunteers
- 400 people
- Sponsor
- Bordeaux Colorectal Institute
Anastomotic Leak, Colorectal Neoplasms
Enhanced Recovery and Patient Blood Management in Colorectal Surgery
To prospectively study the effect of adherence to ERAS and PBM programs on early outcomes after colorectal surgery
- Conditions
- Anastomotic Leak, Colorectal Neoplasms, Blood Transfusion Complication, Colorectal Disorders
- Trial name
- iCral4 (NCT05227014)
- Testing
- Colorectal resection
- Where
- Italy
- Volunteers
- 5,000 people
- Sponsor
- Ospedale Sandro Pertini, Roma
Esophageal Carcinoma, Esophageal Adenocarcinoma
Postoperative Hypoxemia Increases the Risk of Anastomotic Leak After Radical Esophagectomy
This study aims to determine whether postoperative hypoxia (arterial partial pressure of oxygen (PaO₂)<80 mmHg) is an independent risk factor for anastomotic leakage after esophagectomy.
- Conditions
- Esophageal Carcinoma, Esophageal Adenocarcinoma, Esophagectomy, PaO2
- Trial name
- NCT07309991
- Where
- 6 sites in China
- Volunteers
- 2,500 people
- Sponsor
- Sun Yat-sen University
Gastric Cancer
Perianastomotic Drain After Gastrectomy (DRAG)
Gastric cancer ranks as the fifth most common and fifth most lethal cancer globally. For patients with AJCC stages IB to IIIC, representing the majority of cases, the current gold standard of surgical treatment involves total…
- Trial name
- DRAG (NCT04288661)
- Testing
- No drain placement
- Where
- Greece
- Volunteers
- 60 people
- Sponsor
- THEODOROU DIMITRIOS
Anastomotic Leak, Colorectal Surgery
Early Diagnosis of Anastomotic Leakage After Colorectal Surgery: Italian ColoRectal Anastomotic Leakage Study Group.
Prospective evaluation of early diagnosis of anastomotic leak after colorectal resection through evaluation of Dutch leakage score, serum C-reactive protein and serum Procalcitonin
- Trial name
- iCral (NCT03560180)
- Testing
- Dutch score, Serum C-reactive Protein, serum Procalcitonin
- Where
- 18 sites in Italy
- Volunteers
- 1,131 people
- Sponsor
- Ospedale C & G Mazzoni
Rectum Cancer
The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection
A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.
- Trial name
- NCT03699761
- Testing
- Closure of the pelvic peritoneum, Nonclosure of the pelvic peritoneum
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Southwest Hospital, China
ColoRectal Cancer, Colonic Diverticulitis
Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?
A leak from a colorectal anastomosis is a post-operative complication surgeons fear the most, following colonic resection. Over the years, there have been multiple suggestions for intraoperative tests for the integrity of the…
- Conditions
- ColoRectal Cancer, Colonic Diverticulitis, Anastomotic Leak, Anastomotic Complication
- Trial name
- ITCORA (NCT03316677)
- Testing
- Intraoperative testing of colorectal anastomoses, Stapled colorectal anastomoses
- Volunteers
- 150 people
- Sponsor
- Meir Medical Center