An interventional study of Chewing gum in Cancer Esophagus and Pancreatic Cancer, sponsored by Michael Bau Mortensen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-09.
Sponsored by Michael Bau Mortensen · Not applicable, Interventional, and Treatment
Every patient undergoing surgery in the abdomen will experience temporary paralysis of bowel function. This study evaluates whether chewing gum can reduce the bowel paralysis after surgery in patients undergoing either esophageal resection or whipples procedure. Half the study population will receive chewing gum while the other half will act as control.
Every surgical procedure results in a temporary paralysis of bowel function. This condition is named postoperative ileus (POI) and it is characterized by absence of intestine motility, accumulation of gas and fluid inside the intestines and absence of flatus and defecation. It results in nausea, vomiting, abdominal distension, pain and lowered tolerance towards intake of fluid and solid foods. POI is the organism's reaction to the surgical trauma and it is most often the single most important factor determining the length of patient admission. Prolonged POI can also result in medical complications.
The length of POI following elective abdominal surgery is most often 3 to 6 days. Gradually during this period the intestines regain their normal behavioral pattern. The colon is the last segment to regain its motility which decides the patient's wellbeing. Therefore most investigations of POI measure time from surgery to first flatus or defecation.
The cause of POI is found in the surgical trauma. When the abdominal wall and the peritoneum are penetrated and the intestines exposed and handled, the immune system is activated. The immune system creates an inflammatory response that inhibits the local neural pathways in the intestines. The size of the immune response is related to the size of the surgical procedure and the length of POI. Together with the overall hormonal surgical stress response the inflammatory response creates a shift in the autonomous nervous system towards sympathetic domination. This further inhibits bowel activity.
The intake of food activates parasympathetic activity and promotes bowel activity. Early food intake following abdominal surgery, however, is often ill received by the patients hence the above mentioned symptoms of POI. The early food intake can also worsen complications following surgery such as anastomotic leakage. This is most pronounced with anastomoses on the esophagus and stomach. Therefore abstinence from food intake is often recommended in the immediate postoperative period.
Chewing of chewing gum following surgery can be perceived as placebo intake of food because it also activates the parasympathetic nervous system and under normal conditions the cephalic part of the digestion. Gum chewing does not, however, result in worsening of potential surgical complications and it is generally well tolerated by the patients. Postoperative gum chewing has been investigated and found effect full in the shape of reduced POI following colorectal surgery, abdominal surgery on the aorta, bladder surgery, and caesarian section.
The effect of gum chewing following surgery on the esophagus and the pancreas has to our knowledge not yet been investigated.
With this study we wish to investigate the effect of gum chewing on POI in a patient population undergoing either esophageal resection or pancreaticoduodenectomy (whipples procedure) due to cancer in either the esophagus or the pancreas.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
This study's planned enrollment of 72 is above the median of 58 across 1,347 interventional studies indexed under Esophageal Neoplasms.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This intervention group will receive chewing gum four times daily following surgery. Each of which they are encouraged to chew for 30 minutes. Gum chewing is terminated when one of the primary end points occurs.
Other: Chewing gum
This group will receive the normal postoperative treatment. Occurence of primary end points are registrered.
The intervention group will receive chewing gum four times daily following surgery.
Time from surgery to first flatus
Time frame: 7 days
Time from surgery to first defecation
Time frame: 7 days
This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Michael Bau Mortensen