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The effects of stimulation of the autonomic nervous system via perioperative nutrition on postoperative ileus and anastomotic leakage following colorectal surgery (SANICS II trial): a study protocol for a double-blind randomized controlled trial.

Peters EG, Smeets BJ, Dekkers M, Buise MD, de Jonge WJ, Slooter GD, Reilingh TS, Wegdam JA, Nieuwenhuijzen GA, Rutten HJ, de Hingh IH, Hiligsmann M, Buurman WA, Luyer MD - Trials (2015)

Bottom Line: Furthermore, early administration of enteral nutrition reduced anastomotic leakage.Furthermore, a cost-effectiveness analysis will be performed.Consequently, postoperative ileus will be reduced as well as anastomotic leakage.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. emmeline.peters@cze.nl.

ABSTRACT

Background: Postoperative ileus and anastomotic leakage are important complications following colorectal surgery associated with short-term morbidity and mortality. Previous experimental and preclinical studies have shown that a short intervention with enriched enteral nutrition dampens inflammation via stimulation of the autonomic nervous system and thereby reduces postoperative ileus. Furthermore, early administration of enteral nutrition reduced anastomotic leakage. This study will investigate the effect of nutritional stimulation of the autonomic nervous system just before, during and early after colorectal surgery on inflammation, postoperative ileus and anastomotic leakage.

Methods/design: This multicenter, prospective, double-blind, randomized controlled trial will include 280 patients undergoing colorectal surgery. All patients will receive a selfmigrating nasojejunal tube that will be connected to a specially designed blinded tubing system. Patients will be allocated either to the intervention group, receiving perioperative nutrition, or to the control group, receiving no nutrition. The primary endpoint is postoperative ileus. Secondary endpoints include anastomotic leakage, local and systemic inflammation, (aspiration) pneumonia, surgical complications classified according to Clavien-Dindo, quality of life, gut barrier integrity and time until functional recovery. Furthermore, a cost-effectiveness analysis will be performed.

Discussion: Activation of the autonomic nervous system via perioperative enteral feeding is expected to dampen the local and systemic inflammatory response. Consequently, postoperative ileus will be reduced as well as anastomotic leakage. The present study is the first to investigate the effects of enriched nutrition given shortly before, during and after surgery in a clinical setting.

Trial registration: ClinicalTrials.gov: NCT02175979 - date of registration: 25 June 2014. Dutch Trial Registry: NTR4670 - date of registration: 1 August 2014.

No MeSH data available.


Related in: MedlinePlus

Flow diagram for participants who will be included in the study. *Blinded groups and blinded outcome. NJ tube = nasojejunal tube.
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Fig1: Flow diagram for participants who will be included in the study. *Blinded groups and blinded outcome. NJ tube = nasojejunal tube.

Mentions: Patients aged >18 undergoing elective segmental colorectal resection with an anastomosis are eligible for inclusion. A total of 280 patients will be included. Exclusion criteria are previous gastric or esophageal resection, peritoneal carcinomatosis, pre-existent or creation of an ileostomy, steroid use and use of medication that disrupts the acetylcholine metabolism, such as selective serotonin reuptake inhibitors and anticonvulsants. Both the investigator and the responsible surgeon will verify eligibility. If the indication for operation is established, the patient will receive written and oral information about the trial during a scheduled outpatient appointment. Patients will be offered sufficient time to enquire about details of the trial and to decide whether or not they wish to participate. Patients will have to sign the informed consent form in the physical presence of the surgeon or investigator. A participant flow diagram is shown in FigureĀ 1.Figure 1


The effects of stimulation of the autonomic nervous system via perioperative nutrition on postoperative ileus and anastomotic leakage following colorectal surgery (SANICS II trial): a study protocol for a double-blind randomized controlled trial.

Peters EG, Smeets BJ, Dekkers M, Buise MD, de Jonge WJ, Slooter GD, Reilingh TS, Wegdam JA, Nieuwenhuijzen GA, Rutten HJ, de Hingh IH, Hiligsmann M, Buurman WA, Luyer MD - Trials (2015)

Flow diagram for participants who will be included in the study. *Blinded groups and blinded outcome. NJ tube = nasojejunal tube.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4318130&req=5

Fig1: Flow diagram for participants who will be included in the study. *Blinded groups and blinded outcome. NJ tube = nasojejunal tube.
Mentions: Patients aged >18 undergoing elective segmental colorectal resection with an anastomosis are eligible for inclusion. A total of 280 patients will be included. Exclusion criteria are previous gastric or esophageal resection, peritoneal carcinomatosis, pre-existent or creation of an ileostomy, steroid use and use of medication that disrupts the acetylcholine metabolism, such as selective serotonin reuptake inhibitors and anticonvulsants. Both the investigator and the responsible surgeon will verify eligibility. If the indication for operation is established, the patient will receive written and oral information about the trial during a scheduled outpatient appointment. Patients will be offered sufficient time to enquire about details of the trial and to decide whether or not they wish to participate. Patients will have to sign the informed consent form in the physical presence of the surgeon or investigator. A participant flow diagram is shown in FigureĀ 1.Figure 1

Bottom Line: Furthermore, early administration of enteral nutrition reduced anastomotic leakage.Furthermore, a cost-effectiveness analysis will be performed.Consequently, postoperative ileus will be reduced as well as anastomotic leakage.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands. emmeline.peters@cze.nl.

ABSTRACT

Background: Postoperative ileus and anastomotic leakage are important complications following colorectal surgery associated with short-term morbidity and mortality. Previous experimental and preclinical studies have shown that a short intervention with enriched enteral nutrition dampens inflammation via stimulation of the autonomic nervous system and thereby reduces postoperative ileus. Furthermore, early administration of enteral nutrition reduced anastomotic leakage. This study will investigate the effect of nutritional stimulation of the autonomic nervous system just before, during and early after colorectal surgery on inflammation, postoperative ileus and anastomotic leakage.

Methods/design: This multicenter, prospective, double-blind, randomized controlled trial will include 280 patients undergoing colorectal surgery. All patients will receive a selfmigrating nasojejunal tube that will be connected to a specially designed blinded tubing system. Patients will be allocated either to the intervention group, receiving perioperative nutrition, or to the control group, receiving no nutrition. The primary endpoint is postoperative ileus. Secondary endpoints include anastomotic leakage, local and systemic inflammation, (aspiration) pneumonia, surgical complications classified according to Clavien-Dindo, quality of life, gut barrier integrity and time until functional recovery. Furthermore, a cost-effectiveness analysis will be performed.

Discussion: Activation of the autonomic nervous system via perioperative enteral feeding is expected to dampen the local and systemic inflammatory response. Consequently, postoperative ileus will be reduced as well as anastomotic leakage. The present study is the first to investigate the effects of enriched nutrition given shortly before, during and after surgery in a clinical setting.

Trial registration: ClinicalTrials.gov: NCT02175979 - date of registration: 25 June 2014. Dutch Trial Registry: NTR4670 - date of registration: 1 August 2014.

No MeSH data available.


Related in: MedlinePlus