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ID
Source
Brief title
Health condition
Bacterial translocation, total colectomy, proctocolectomy, intestinal permeability, devascularisation, laparoscopic colectomy.
Bacteriele translocatie, proctocolectomie, intestinale permeabiliteit, devascularisatie, laparoscopie
Sponsors and support
department of Surgery
Amsterdam
department of Surgery
Amsterdam
Intervention
Outcome measures
Primary outcome
1. Intestinal permeability;
2. Amount of bacterial translocation
Secondary outcome
-
Background summary
Background: Postoperative infectious complications such as pneumonia, sepsis, abscess, urinary tract infection, and cholangitis are mainly caused by the patient’s 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.
Study objective
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.
Intervention
Devascularisation beginning left or right in case of laparoscopice colectomy. In case of open colectomy mobilization from lateral to medial
P.O. Box 22660
W.A. Bemelman
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
W.A.Bemelman@amc.uva.nl
P.O. Box 22660
W.A. Bemelman
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
W.A.Bemelman@amc.uva.nl
Inclusion criteria
1. 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 criteria
1. Antibiotics within a week prior to surgery (perioperative antibiotics are allowed);
2. Use of probiotic products 4 weeks before or during the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL996 |
NTR-old | NTR1025 |
Other | : |
ISRCTN | ISRCTN82467578 |