Effects of Chewing Gum Against Postoperative Ileus

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy.

Clinical Trial Description

Postoperative ileus is common after surgery. One non-pharmacological intervention that has shown promising results in reducing the duration of postoperative ileus is chewing gum after surgery. However, this has not been investigated in upper gastrointestinal surgery such as pancreatic surgery. Hence the aim of this study was to investigate the effects of chewing gum treatment on patients undergoing pancreaticoduodenectomy due to pancreatic or periampullary cancer.

This study was conducted as a phase-III trial. Patients diagnosed with pancreatic tumours scheduled for pancreaticoduodenectomy were included. The treatment group received chewing gum postoperatively and standard care. Controls received glucose solution and standard care.

Participants were included on the day of admission, which was the day prior to surgery. Randomization to the two groups (1:1) was done when patients returned from the intensive care unit (ICU) to the ward. This procedure was chosen in order to avoid perioperative drop-outs due to inoperable tumors. With a power of 80% and a level of significance of 0.05, 18 patients were needed in each group.Comparisons between the groups were analyzed with non-parametric tests; the Mann Whitney U test and Chi 2 test.

Controls received standard care and sips of glucose, in total 3.6g/day in a 12-ml mixture per day, the same amount of glucose per day as the treatment group received via the chewing gum. The chewing gum used was ChiczaTM, a natural organic gum whose main ingredients are latex, glucose and natural flavors (lime or spearmint). Patients started to chew after they returned from the ICU the day after surgery. Chewing gum was administered every fourth hour (08.00-12.00, 12.00-16.00 and 16.00-20.00). During each four-hour period, patients chewed two pieces of gum for 30 minutes each. Chewing gum was used during the whole hospital stay. The time to the first postoperative flatulence and defecation was recorded, in addition to standard clinical data. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02319512
Study type	Interventional
Source	Sahlgrenska University Hospital, Sweden
Contact
Status	Terminated
Phase	Phase 3
Start date	January 2012
Completion date	December 2013

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.