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Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study.

ABSTRACT: When postoperative ileus is not resolved after 5 days or recurs after resolution, prolonged POI (PPOI) is diagnosed. PPOI increases discomfort, morbidity and hospitalisation length, and is mainly caused by an inflammatory response following intestinal manipulation. This response can be weakened by targeting the cholinergic anti-inflammatory pathway, with nicotine as essential regulator. Chewing gum, already known to stimulate gastrointestinal motility itself, combined with nicotine is hypothesised to improve gastrointestinal recovery and prevent PPOI. This pilot study is the first to assess efficacy and safety of nicotine gum in colorectal surgery.Patients undergoing elective oncological colorectal surgery were enrolled in this double-blind, parallel-group, controlled trial and randomly assigned to a treatment protocol with normal or nicotine gum (2 mg). Patient reported outcomes (PROMS), clinical characteristics and blood samples were collected. Primary endpoint was defined as time to first passage of faeces and toleration of solid food for at least 24 h.In total, 40 patients were enrolled (20 vs. 20). In both groups, six patients developed PPOI. Time to primary endpoint (4.50 [3.00-7.25] vs. 3.50 days [3.00-4.25], p = 0.398) and length of stay (5.50 [4.00-8.50] vs. 4.50 days [4.00-6.00], p = 0.738) did not differ significantly between normal and nicotine gum. There were no differences in PROMS, inflammatory parameters and postoperative complications.We proved nicotine gum to be safe but ineffective in improving gastrointestinal recovery and prevention of PPOI after colorectal surgery. Other dosages and administration routes of nicotine should be tested in future research.

SUBMITTER: Lambrichts DPV

PROVIDER: S-EPMC5554272 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study.

Lambrichts Daniël P V DPV Boersema Geesien S A GSA Tas Buket B Wu Zhouqiao Z Vrijland Wietske W WW Kleinrensink Gert-Jan GJ Jeekel Johannes J Lange Johan F JF Menon Anand G AG

International journal of colorectal disease 20170628 9

<h4>Purpose</h4>When postoperative ileus is not resolved after 5 days or recurs after resolution, prolonged POI (PPOI) is diagnosed. PPOI increases discomfort, morbidity and hospitalisation length, and is mainly caused by an inflammatory response following intestinal manipulation. This response can be weakened by targeting the cholinergic anti-inflammatory pathway, with nicotine as essential regulator. Chewing gum, already known to stimulate gastrointestinal motility itself, combined with nicoti ...[more]

PMID: 28660314

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Project description:Nausea and vomiting are common complications in patients undergoing caesarean delivery under regional anaesthesia. When experienced after surgery, they may delay recovery, reduce patient satisfaction and affect the bonding between mother and baby. Various pharmacological and non-pharmacological approaches for prophylaxis and treatment of postoperative nausea and vomiting (PONV) have been employed with different degree of efficacy. In this pilot randomised controlled trial, we aimed to determine the possible preventative effects of chewing gum on the rate of PONV in expectant mothers undergoing neuraxial anaesthesia for elective lower segment caesarean section. All participants underwent spinal anaesthesia with administration of 10-11.5 mg of intrathecal heavy Bupivicaine 0.5% according to anaesthetists' preference, Morphine 100 μg and Fentanyl 25 μg. Postoperative analgesia regimen was also standardised. Two hundred ninety-six patients were randomised to an intervention arm to receive chewing gum in addition to standard therapy and to a non-intervention arm to receive standard therapy. After exclusions, 258 patients were followed up 24 h postoperatively. Standard therapy is defined as Ondansetron 4 mg IV intra-operatively. The primary outcomes were the incidences of nausea and vomiting in the first 24 h postoperatively. Secondary outcomes were the number of episodes of nausea or vomiting in the recovery room and on the ward 24 h postoperatively, use of anti-emetics postoperatively, severity of nausea and patient satisfaction with the intervention. Our study revealed no significant differences in rates of postoperative nausea and vomiting between the intervention and standard therapy groups (41.4% v 36.9% p = 0.461). There were no significant differences in secondary outcomes between groups. Chewing gum does not reduce the incidence of PONV after elective LSCS under spinal anaesthesia. Our trial was registered with clinicaltrials.org (NCT04191694).

Project description:Delirium is a neurobehavioural syndrome that frequently develops in the postoperative setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 10 to 80% (Schonauer et al., J Pept Sci. 2017). Delirium was first described more than half a century ago in the cardiac surgery population (Blachy and Starr, Am J Psychiatry 121:371-5, 1964), where it was already discovered as a state that might be accompanied by serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. Furthermore, the duration of delirium is associated with worse long-term cognitive function in the general ICU population (Sessler et al., Am J Respir Crit Care Med 166:1338-44, 2002). This long-term experience with delirium suggests a high socioeconomic burden and has been a focus of many studies (Nishio et al., Crit Care Med 5:953-7, 1997; Ehlenbach et al., JAMA 303:763-70, 2010; Jahangir et al., World J Cardiol 3:383-7, 2011; Abegunde et al., Lancet 370:1929-1938, 2007; Darmon et al., Intensive Care Med 43:829-840, 2017; Marino et al., J Nephrol 28:717-24, 2015; Ng LL et al., J Am Coll Cardiol 69:56-69, 2017; Sezen et al., J Pharmacol Exp Ther 287:238-45, 1998; Kim et al., Ann Lab Med 37:388-97, 2017). Due to the multifactorial origin of delirium, we have several but no incontestable options for prevention and symptomatic treatment. Overall, delirium represents a high burden not only for patient and family members, but also for the medical care team that aims to prevent postoperative delirium to avoid serious consequences associated with it. The purpose of this study is to determine whether postoperative delirium can be prevented by the combination of established preventive agents. In addition, measured levels of pre- and postoperative cortisol, neuron specific enolase (NSE) and S-100? will be used to investigate dynamics of these parameters in delirious and non-delirious patients after surgery.The Baden PRIDe Trial is an investigator-initiated, phase IV, two-centre, randomised, placebo-controlled, double-blind clinical trial for the prevention of delirium with haloperidol, ketamine, and the combination of both vs. placebo in 200 patients scheduled for surgery. We would like to investigate superiority of one of the three treatment arms (i.e., haloperidol, ketamine, combined treatment) to placebo.There is limited but promising evidence that haloperidol and ketamine can be used to prevent delirium. Clinical care for patients might improve as the results of this study may lead to better algorithms for the prevention of delirium.ClinicalTrials.gov, NCT02433041 . Registered on 7 April 2015. Swiss National Clinical Trial Portal, SNCTP000001628. Registered on 9 December 2015.

Dataset Information

Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study.

Publications

Nicotine chewing gum for the prevention of postoperative ileus after colorectal surgery: a multicenter, double-blind, randomised, controlled pilot study.

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