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Cancer EsophagusNCT02260128

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

A study testing Chewing gum in people with Cancer Esophagus and Pancreatic Cancer, run by Michael Bau Mortensen at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer Esophagus, Pancreatic Cancer
What is being tested?
Chewing gum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteDenmark
Study dates
Nov 2014to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients undergoing esophageal/cardial resection due to cancer and patients undergoing whipples procedure due to cancer.
  • Macroradical resection must be accomplished.
  • Informed consent given.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Christian Lolle Norregaard, MD contact

004520949779

clnorregaard@gmail.com

Michael Bau Mortensen, Professor contact

michael.bau.mortensen@rsyd.dk

Denmark1 site
  • Department of Surgery, Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

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.

Read the detailed 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.

Being tested
Chewing gum
Keywords
postoperative ileus, chewing gum
Medical subject headings
Esophageal Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chewing gumOther

    The intervention group will receive chewing gum four times daily following surgery.

Study groups in NCT02260128
Study groupRoleWhat they receive
Gum chewingExperimentalThis 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.
Receives: Other: Chewing gum
Control groupNo interventionThis group will receive the normal postoperative treatment. Occurence of primary end points are registrered.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from surgery to first flatus

    Measured: 7 days

  2. Time from surgery to first defecation

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02260128
Sponsor's protocol ID
Tyggegummi
Status last verified
Oct 2014
First submitted
5 Oct 2014
Last updated
9 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Chewing gum in people with Cancer Esophagus and Pancreatic Cancer, run by Michael Bau Mortensen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christian Lolle Norregaard, MD (004520949779, clnorregaard@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from surgery to first flatus (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.

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