search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Bacterial translocation, and intestinal permeability in patients undergoing open or laparoscopic total colectomy. - open, right side or left side first laparoscopically -


- candidate number2669
- NTR NumberNTR1025
- ISRCTNISRCTN82467578
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR23-jul-2007
- Secondary IDs 
- Public TitleBacterial translocation, and intestinal permeability in patients undergoing open or laparoscopic total colectomy. - open, right side or left side first laparoscopically -
- Scientific TitleBacterial translocation, and intestinal permeability in patients undergoing open or laparoscopic total colectomy. - open, right side or left side first laparoscopically -
- ACRONYMBactTrans
- hypothesisWe hypothesise that bacterial translocation is the least in open colectomy followed by laparoscopic colectomy starting the devascularisation on the left side followed by laparoscopic colectomy starting the devascularisation on the right side. The longer period of devascularisation results in an increased permeability and higher risk of bacterial translocation.
- Healt Condition(s) or Problem(s) studiedLaparoscopy, Bacterial translocation, Intestinal permeability, Proctocolectomy, Colectomy, Devascularisation
- Inclusion criteria1. Age >18 years; 2. Patients planned for laparoscopic total colectomy for inflammatory bowel diseases or familial adenomatous polyposis or patients undergoing subtotal colectomy; 3. Informed consent.
- Exclusion criteria1. Antibiotics within a week prior to surgery (perioperative antibiotics are allowed); 2. Use of probiotic products 4 weeks before or during the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-mrt-2006
- planned closingdate1-jul-2008
- Target number of participants40
- InterventionsDevascularisation beginning left or right in case of laparoscopice colectomy. In case of open colectomy mobilization from lateral to medial
- Primary outcome1. Intestinal permeability; 2. Amount of bacterial translocation
- Secondary outcome-
- Timepoints
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. W.A. Bemelman
- CONTACT for SCIENTIFIC QUERIESMD P.J. Koperen, van
- Sponsor/Initiator Academic Medical Center (AMC), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Surgery
- Publicationsn/a
- Brief summaryBackground: Postoperative infectious complications such as pneumonia, sepsis, abscess, urinary tract infection, and cholangitis are mainly caused by the patientís own gut flora probably due to bacterial translocation. Bacterial translocation describes the passage of bacteria from the gastrointestinal tract to normally sterile tissues such as the mesenteric lymph nodes and other internal organs. Objectives: To assess whether bacterial translocation occurs during laparoscopic total colectomy compared to open colectomy, and to determine whether the order of devascularisation matters with respect to bacterial translocation, and intestinal permeability. Hypothesis: We hypothesise that bacterial translocation is the least in open colectomy followed by laparoscopic colectomy starting the devascularisation on the left side followed by laparoscopic colectomy starting the devascularisation on the right side. The longer period of devascularisation results in an increased permeability and higher risk of bacterial translocation. Patients and Methods: A total of 30 patients who are planned to undergo an open or laparoscopic total colectomy for inflammatory bowel diseases or familial adenomatous polyposis from AMC Amsterdam will be included in this study. After informed consent, patients that are planned to undergo a laparoscopic operation will be randomly assigned to 2 groups (right or left side first) using sealed envelopes. A third group will be a control group consisting of patients undergoing an open operation. Study parameters will be a) the concentration of polyethylene glycol (PEG) in the urine, b) the concentration of intestinal fatty acid binding protein (IFABP-c) in the urine, c) collection of mesenteric lymph nodes from the distal ileum and d) distal ileum full-thickness biopsies from the surgical resection specimen.
- Main changes (audit trail)
- RECORD23-jul-2007 - 27-aug-2007


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl