Projektdetaljer
Beskrivelse
Rationale: Postoperative ileus and anastomotic leakage are complications associated with short-term morbidity and mortality following colorectal surgery. Based on experimental studies, we hypothesize that enriched enteral nutrition shortly before, during and early after colorectal surgery reduces inflammation by stimulation of the autonomic nervous system and thereby postoperative ileus (POI) and anastomotic leakage.
Objective: The main objective is to investigate the effects of perioperative nutrition on postoperative ileus and anastomotic leakage in patients undergoing colorectal surgery.
Study design: A prospective randomized double blinded controlled trial conducted as a multicenter study in Danmark and Holland.
Study population: Patients undergoing elective segmental colon resection with a primary anastomosis for colonic cancer >18 years.
Intervention: Perioperative nutrition via a nasojejunal tube.
Main study parameters: Main clinical outcome parameters are postoperative ileus and anastomotic leakage. Risk of aspiration pneumonia is closely monitored. Before intubation, gastric volumes are measured and the stomach is emptied. The inflammatory response will be quantified by standard assays including Enzyme Linked Immunosorbent Assay (ELISA) and Polymerase Chain Reaction (PCR). Mediators important in the pathogenesis of POI will also be measured in peritoneal lavage fluid. Clinical parameters are prospectively registered in a database and complications are classified using the Clavien-Dindo classification of surgical complications. Other parameters include intestinal barrier integrity and local inflammation in the intestine (measured by PCR and immunohistochemistry) as well as gastrointestinal motility (measured by a portable 3D electromagnetic system). Long-term outcome parameters such as local recurrence, overall and cancer-specific survival will also be registered.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All patients will receive a self-migrating nasojejunal tube (Flocare Bengmark) one day before surgery. The position of the tube is controlled with X-ray the same day. Using a specially designed blinded setup (produced by ECM bv, Gemert) patients in the intervention group receive enriched enteral nutrition in low amounts before, during and directly after surgery until oral intake is started. Patients in the control group do not receive nutrition and get a standard preoperative fast until standard oral intake is commenced.
Blood samples will be collected at several predefined moments in relation to the moment of incision.
Peritoneal lavage is performed at the start of surgery and at the end of surgery. Also gastric content is measured during surgery.
Objective: The main objective is to investigate the effects of perioperative nutrition on postoperative ileus and anastomotic leakage in patients undergoing colorectal surgery.
Study design: A prospective randomized double blinded controlled trial conducted as a multicenter study in Danmark and Holland.
Study population: Patients undergoing elective segmental colon resection with a primary anastomosis for colonic cancer >18 years.
Intervention: Perioperative nutrition via a nasojejunal tube.
Main study parameters: Main clinical outcome parameters are postoperative ileus and anastomotic leakage. Risk of aspiration pneumonia is closely monitored. Before intubation, gastric volumes are measured and the stomach is emptied. The inflammatory response will be quantified by standard assays including Enzyme Linked Immunosorbent Assay (ELISA) and Polymerase Chain Reaction (PCR). Mediators important in the pathogenesis of POI will also be measured in peritoneal lavage fluid. Clinical parameters are prospectively registered in a database and complications are classified using the Clavien-Dindo classification of surgical complications. Other parameters include intestinal barrier integrity and local inflammation in the intestine (measured by PCR and immunohistochemistry) as well as gastrointestinal motility (measured by a portable 3D electromagnetic system). Long-term outcome parameters such as local recurrence, overall and cancer-specific survival will also be registered.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All patients will receive a self-migrating nasojejunal tube (Flocare Bengmark) one day before surgery. The position of the tube is controlled with X-ray the same day. Using a specially designed blinded setup (produced by ECM bv, Gemert) patients in the intervention group receive enriched enteral nutrition in low amounts before, during and directly after surgery until oral intake is started. Patients in the control group do not receive nutrition and get a standard preoperative fast until standard oral intake is commenced.
Blood samples will be collected at several predefined moments in relation to the moment of incision.
Peritoneal lavage is performed at the start of surgery and at the end of surgery. Also gastric content is measured during surgery.
| Status | Afsluttet |
|---|---|
| Effektiv start/slut dato | 01/10/2015 → 06/02/2018 |