Perioperative administration of probiotics or SDD has an effect on small bowel bacterial overgrowth and bacterial translocation to lymph nodes in patients undergoing PPPD by protecting or enhancing bowel (mucosa) permeability.
ID
Bron
Verkorte titel
Aandoening
Diseases of the pancreas requiring a pyloric preserving pancreaticoduodenectomy.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Intestinal permeability and bacterial translocation following major pancreaticobiliary surgery.
Achtergrond van het onderzoek
Postoperative infectious complications are mainly caused by the patient’s own gut flora. Both the use of enteral probiotics and selective decontamination of the digestive tract (SDD) have been described as succesfull techniques to reduce bacterial translocation and subsequent infectious complications.
- This study aims to quantify the effect of these techniques on the gut flora and the bacterial translocation.
Patients with pylorus preserving pancreaticoduodenectomy (PPPD) are studied because in these patients are a homogeneous group with major surgery may lead to postoperative impaired gastrointestinal motility and bacterial overgrowth.
A total of 30 adult patients who are planned to undergo a pylorus-preserving pancreaticoduodenectomy in the AMC Amsterdam or in the UMC Utrecht.
Preoperatively, excessive cholestasis has been drained, usually by ERCP.
- After informed consent, patients will be randomly assigned to 3 groups.
Group A (n=10) will receive probiotics.
Group B (n=10) will receive SDD.
Group C (n=10) will receive standard treatment.
All patients will receive standardized anesthesia and postoperative analgesia.
The effect of preoperative prophylaxis regimes can be assessed by bacterial counts in a small jejunal biopsy and an adjacent lymphnodes.
Also the effect of the prophylactic regimes on gut permeability, cytokine production and faecal flora will be assesed.
Doel van het onderzoek
Perioperative administration of probiotics or SDD has an effect on small bowel bacterial overgrowth and bacterial translocation to lymph nodes in patients undergoing PPPD by protecting or enhancing bowel (mucosa) permeability.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Group A (n=10) will receive probiotics.
Group B (n=10) will receive SDD.
Group C (n=10) will receive standard treatment.
Publiek
P.O. Box 226600
M.A. Boermeester
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
m.a.boermeester@amc.uva.nl
Wetenschappelijk
P.O. Box 226600
M.A. Boermeester
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
m.a.boermeester@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age >18 years;
2. Patients planned for pylorus preserving pancreaticoduodenectomy for suspected malignant or premalignant disease;
3. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Antibiotics within a week prior to surgery (perioperative antibiotics are allowed);
2. Use of other probiotic products 4 weeks before or during the study;
3. Non-resectable cancer of the pancreas.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL242 |
NTR-old | NTR280 |
Ander register | : N/A |
ISRCTN | ISRCTN71637623 |