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
نویسندگان
چکیده
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.
منابع مشابه
Stimulation of the autonomic nervous system in colorectal surgery: a study protocol for a randomized controlled trial
BACKGROUND Postoperative ileus (POI) is a well-known complication of abdominal surgery and is considered to be caused by a local inflammation in the gut. Previously it has been shown that both local and systemic inflammation can be reduced by stimulation of the autonomic nervous system via lipid rich nutrition. Stimulation of the autonomic nervous system releases acetylcholine from efferent vag...
متن کاملEfficacy of Biofeedback Therapy before and after Sphincteroplasty for Fecal Incontinence because of Obstetric Injury: A Randomized Controlled Trial
Fecal incontinence is a challenging condition in that it exerts various psychosocial impacts on daily life. Different treatment modalities have been suggested for fecal incontinence. The present study aimed to evaluate the efficacy of biofeedback therapy in combination with surgery in the management of fecal incontinence.The present randomized controlled trial was performed on 27 women with a c...
متن کاملThe Positive Effects of Zinc Supplements on the Improvement of Primary Dysmenorrhea and Premenstrual Symptoms: A Double-blind, Randomized, Controlled Trial
Background & aim:Primary dysmenorrhea can be relieved via some medical and non-medical approaches. In this regard, the probable therapeutic role of zinc supplements has been recently emphasized. The present study was conducted to determine the positive effects of zinc supplements on relieving primary dysmenorrhea and premenstrual symptoms. Methods:The present double-blind, randomized, controlle...
متن کاملAdministration of Iranian Propolis attenuates oxidative stress and blood glucose in type II diabetic patients: a randomized, double-blind, placebo-controlled, clinical trial
Background: Hyperglycemia in diabetic people resulted in oxidative conditions. Propolis is the third most important component of bee products which has various functional properties such as anti-oxidant due to its components. The aim of this study was to evaluate the propolis effect on fructosamine level, the catalase activity, and the level of oxidized LDL changes in type 2 diabetic patients. ...
متن کاملReduction of some atherogenic indices in patients with non-alcoholic fatty liver by Vitamin D and calcium co-supplementation: a double blind randomized controlled clinical trial
The role of non-alcoholic fatty liver disease (NAFLD) as a potential independent cardiovascular disease (CVD) risk factor has recently gained considerable attention because CVD is the common cause of death in NAFLD patients. We aimed to estimate the effects of vitamin D supplementation alone or in combination with calcium on atherogenic indices, liver function tests and grade of disease in pati...
متن کامل