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Anastomotic Leak clinical trials

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NCT ID: NCT03316677 Not yet recruiting - ColoRectal Cancer Clinical Trials

Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?

ITCORA
Start date: November 1, 2017
Phase: N/A
Study type: Interventional

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 colorectal anastomosis. Two of the most common tests that are performed routinely are: 1. Air tight leak test - filling the pelvis with saline and insufflating air trans anal - looking for air bubbles in the saline filled pelvis. 2. Injecting diluted dye (methylene blue) trans anal, and looking for blue dye stains on gauze pads covering the outer side of anastomosis. The aim of the study is to compare the two methods, and to assess if there is a superior method. A secondary aim is to establish standards to perform the test, mainly to assess the appropriate pressure to apply on the anastomosis. In this prospective study patients scheduled to undergo colonic resection of their distal part of the colon/ rectum with colorectal anastomosis, will have both testing methods performed sequentially and will be followed post-operative to assess the yield and sensitivity of the testing methods.

NCT ID: NCT02770911 Not yet recruiting - Laparoscopy Clinical Trials

Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer

Start date: June 2016
Phase: Phase 3
Study type: Interventional

The study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection.

NCT ID: NCT02634112 Not yet recruiting - Anastomotic Leak Clinical Trials

Spanish National Registry of ANAstomotic Leakage in CAncer of the REctum (ANACARE)

ANACARE
Start date: January 2016
Phase: N/A
Study type: Observational [Patient Registry]

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 Registry is to systematize the collection of information on the different surgical services. This Registry claims to have National audit functions, allowing thus the knowledge of the procedures performed at each center that could enable the establishment of the best standard of care. Secondary Endpoints: To determine the real incidence of anastomotic leakage according to the different locations and techniques: uniform definition of anastomotic leakage. To analyze the preoperative risk factors of anastomotic leakage: PATIENT FACTOR. To analyse the variability in the practice of rectal anastomosis: SURGEON FACTOR. To analyse the influence of different stapling devices in rectal anastomosis: INSTRUMENTAL FACTOR To know the current treatment of anastomotic leakage and the associated morbidity and mortality. To create and validate an anastomotic leakage predictive Score.

NCT ID: NCT01324856 Not yet recruiting - Pancreatic Cancer Clinical Trials

Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy

PanAm
Start date: April 2011
Phase: Phase 1
Study type: Interventional

Pancreaticoduodenectomy is the standards surgical procedure for various malignant and benign disease of the pancreas and periampullariy region. During the recent years, mortality rate of pancreaticoduodenectomy has decreased to 5% in specialized centers. Although, this procedure still carries considerable morbidity up to 40%, depending of definition of complications. Pancreatic fistula remains a common complication and the main cause of other morbidities and mortality. Pancreaticojejunal (PJ) anastomosis is the most often used method of reconstruction after pancreaticoduodenectomy. Several technique modifications such as placement of the stents, reinforcement of anasomosis with fibrin glue, pancreatic duct occlusion and pancreaticogastrostomy (PG) type of anastomosis was used in order to decrease pancreatic fistula rate. Since, some retrospective studies showed better results with some technique, several meta-analyses did not show any advantage of those various modifications. It was shown that the higher risk of pancreatic fistula was noticed in patients with soft residual pancreas and small diameter of pancreatic duct. There is only one randomized study in the literature dealing with this problem. This study did not reveal any significant differences between PG and PJ in patients with soft pancreas and small duct. In order to investigate once more this important issue, the researchers conducted randomized multicenter controlled trial.

NCT ID: NCT01139424 Not yet recruiting - Postoperative Clinical Trials

Closure of Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing

GASTROSUTURE
Start date: June 2010
Phase: N/A
Study type: Interventional

Patients with suspected leakage at the specified surgical anastomoses undergo an immediate diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to standard surgical care.

NCT ID: NCT00643084 Not yet recruiting - Clinical trials for Surgical Site Infection

Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery

Start date: May 2008
Phase: N/A
Study type: Interventional

Research Question: Are anastomotic leak and surgical site infection rates equivalent in patients having laparoscopic bowel resections without bowel preparation vs those having bowel preparation? Bowel preparation is a distressing and uncomfortable procedure for patients undergoing laparoscopic colorectal surgery, and also carries some risk of morbidity due to dehydration, electrolyte inbalance and possible infectious complications. If it is found that there is no difference between those patients who have preoperative bowel preps and those who do not have them, then we can save these patients this additional distress and risk at the time of their surgery.