Effect of Chewing Gum on Postoperative Bowel Function Following Upper GI Tract Cancer Surgery

Pancreatic Cancer Clinical Trial

Official title:

Effect of Chewing Gum on Postoperative Bowel Function Following Upper GI Tract Cancer Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02260128
• Other study ID #: Tyggegummi
• Status: Not yet recruiting
• Phase: N/A
• First received: October 5, 2014
• Last updated: October 8, 2014
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2014
• Source: Odense University Hospital
• Contact: Christian Lolle Norregaard, MD
• Phone: 004520949779
• Email: clnorregaard[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing esophageal/cardial resection due to cancer and patients undergoing whipples procedure due to cancer.

• Macroradical resection must be accomplished.

• Informed consent given.

Exclusion Criteria:

• Patients WHO fail to follow the study regimen for more than 24 hours.

• Patients under the age of 18 years.

• Pregnant or beast feeding women.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer Esophagus
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Chewing gum
The intervention group will receive chewing gum four times daily following surgery.

Locations

Country	Name	City	State
Denmark	Department of Surgery, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Michael Bau Mortensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from surgery to first flatus		7 days	No
Primary	Time from surgery to first defecation		7 days	No