Clinical trials: Leak, Anastomotic
Rectal Cancer, Anastomotic Leak
Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing
LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored.
- Trial name
- NCT02907385
- Testing
- LifeSeal™ Kit
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 736 people
- Sponsor
- LifeBond Ltd.
Colorectal Anastomosis Leak
Impact of Oxygen Saturation Levels on Anastomotic Leakage and Postoperative Complications in Colorectal Surgery
The aim of the present study was to evaluate the association between postoperative oxygen saturation levels and surgical complications, with particular emphasis on anastomotic leakage, in patients undergoing elective colorectal…
- Trial name
- NCT07534618
- Where
- Turkey (Türkiye)
- Volunteers
- 174 people
- Sponsor
- Yasir Musa Kesgin
Intestinal Anastomotic Leak, Intestinal Perforations
Endosponge Vacuum Therapy (E-VAC) Registry of Intestinal Anastomotic Leaks and Perforations
The purpose of this registry is to collect data on the clinical use of endoluminal vacuum (E-Vac) therapy to treat both upper and lower intestinal leaks and perforations.
- Trial name
- NCT02477930
- Testing
- No interventions are done
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Baylor Research Institute
Rectal Cancer
Monitoring by Microdialysis of Postoperative Complications After Proctectomy
The aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.
- Trial name
- MTM-COLON-II (NCT01999634)
- Testing
- cma microdialysis catheter placement
- Where
- France
- Volunteers
- 21 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Perforation of the Oesophagus, Perforation of the Colon
VAC-Stent Registry
This registry is intended to collect data on quality assurance and use of the VAC-Stent® and thus verify the suitability of the VAC-Stent® for sealing leakages in the oesophagus or colon.
- Trial name
- NCT04884334
- Testing
- VAC-Stent®
- Where
- 14 sites in Germany
- Volunteers
- 110 people
- Sponsor
- Markus M. Heiss
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
Surgical Anastomosis
ICG Anastomotic Control in Digestive System Surgery
This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing…
- Trial name
- NCT06270745
- Testing
- indocyanine green
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shandong Linglong Yingcheng Hospital
Colorectal Cancer, Anastomotic Leak
Quantitative ICG Fluorescence Angiography in 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.
- Trial name
- QUANTICO (NCT05153954)
- Testing
- Quantitative Indocyanine Green Fluorescence Angiography
- Where
- 2 sites in Denmark
- Volunteers
- 114 people
- Sponsor
- Zealand University Hospital
Anastomotic Leakage
Oral Anti-Infective Agent for Esophageal Anastomotic Leakage
Anastomotic leakage is still to be a major cause of considerable morbidity and mortality after esophagectomy and gastric pull up for esophageal carcinoma.
- Trial name
- NCT00942526
- Testing
- Mycostatin oral suspension, Water
- Where
- Taiwan
- Volunteers
- 120 people
- Sponsor
- National Taiwan University Hospital
Anastomotic Leak
Predictors of Intestinal Anastomosis Leakage, Application of New Predictors and New Scores
Aim of the work This study aims at; Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leakage with application…
- Trial name
- NCT04422106
- Testing
- Predictors of intestinal anastomosis leakage, application of new predictors and new scores
- Where
- Egypt
- Volunteers
- 118 people
- Sponsor
- Mansoura University
Esophageal Cancer, Anastomotic Leakage
Detection of Anastomotic Leakage After Esophageal Surgery
Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior.
- Trial name
- NCT00642525
- Testing
- Contrast swallow radiography, endoscopy
- Where
- Germany
- Volunteers
- 55 people
- Sponsor
- Heidelberg University
Anastomotic Leak
Decreasing Leak Rate in Colorectal Surgery Using Near Infra-red (NIR) Imaging
Anastomotic leak is a devastating complication of colorectal surgery. There is no widespread means of assessing the viability of a laparoscopic anastomosis.
- Trial name
- NCT02459405
- Testing
- NIR anastomotic perfusion assessment, Near infrared camera
- Where
- 4 sites in Ireland, Italy and 2 more
- Volunteers
- 504 people
- Sponsor
- University Hospital, Geneva
Anastomotic Leak Rectum
Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery
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…
- Trial name
- ORSY (NCT05174910)
- Testing
- Obsidian ASG
- Where
- 13 sites in Austria, Germany and 3 more
- Volunteers
- 250 people
- Sponsor
- Vivostat
Colorectal Cancer (CRC), Surgery, Colorectal
Study of Colorectal Anastomosis Failures With First Sigmoid or Left Colonic Artery Preservation With D3 Lymphadenectomy
This study is a randomized, controlled trial comparing the short- and long-term outcomes of left colonic artery or first sigmoid artery preservation for rectal surgery.
- Conditions
- Colorectal Cancer (CRC), Surgery, Colorectal, Oncology
- Trial name
- COLAP-D3 (NCT06938490)
- Testing
- Anterior rectal resection with D3-lymphatic dissection
- Where
- Russia
- Volunteers
- 778 people
- Sponsor
- the BELOOSTROV Clinic of High Technologies
Anastomotic Leak
Risk Factors Associated With Anastomotic Leak and Perioperative Mortality in Elderly
This is a retrospective cohort study of all consecutive patients who underwent colon or rectal resection, between the years 2012-2017 at Rabin Medical Center, a tertiary referral center in Israel.
- Trial name
- NCT04518384
- Testing
- colon or rectum resection
- Where
- Israel
- Volunteers
- 536 people
- Sponsor
- Rabin Medical Center
Anastomotic Leakage, Colorectal Cancer
Predictive Factors for Anastomotic Leakage After Colorectal Surgery
Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide, estimated to be responsible for almost 610,000 deaths in 2008.
- Conditions
- Anastomotic Leakage, Colorectal Cancer, Anastomotic Leak, Colorectal Neoplasms
- Trial name
- REVEAL (NCT02347735)
- Testing
- No interventions, only data collection
- Where
- 4 sites in Netherlands
- Volunteers
- 774 people
- Sponsor
- Maastricht University Medical Center
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
Anastomotic Leak Esophagus
OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy
Oesophagectomy is very invasive surgery. A leakage at the level of the connection between oesophagus and stomach made during surgery causes a lot more problems and can lead to death.
- Trial name
- Obsidian ph II (NCT05713955)
- Testing
- Obsidian
- Where
- 2 sites in Belgium
- Volunteers
- 90 people
- Sponsor
- University Hospital, Ghent
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
Colorectal Surgery
Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection
Anastomotic leakage is a major and potentially mortal complication with an incidence of 10-13% after resection of the rectum. For patients showing no clinical signs of peritonitis, the traditional method has been a conservative…
- Trial name
- NCT00773981
- Testing
- Transrectal vacuum assisted drainage
- Where
- Denmark
- Volunteers
- 60 people
- Sponsor
- Hvidovre University Hospital