Effects of Chewing Gum Against Postoperative Ileus

Postoperative Ileus Clinical Trial

Official title:

Effects of Chewing Gum Against Postoperative Ileus After Pancreaticoduodenectomy - a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02319512
• Other study ID #: 1818111
• Secondary ID: VGFOUGSB-1818111
• Status: Terminated
• Phase: Phase 3
• First received: December 7, 2014
• Last updated: December 13, 2014
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.

• Understand and speak swedish

• No diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function

• No ongoing treatment for mental disease

• No ongoing abuse of alcohol or other drugs

• No previously known allergies to the content of chewing gum

Exclusion Criteria:

• Additional surgery after primary surgery.

• No radical curative surgery

• Previous abdominal surgery.

Study Design

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

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Other:
• Chewing gum
ChiczaTM organic chewing gum 6 pieces a day
• Glucose
12ml glucose solution (13,6g) per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Andersson

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First flatus after surgery		From day of surgery until first postoperative flatus (with in the first 21 days)	No
Primary	First stool after surgery		From day of surgery until first stool (with in the first 21 days)	No
Secondary	Start of clear fluids		From day of surgery until start of clear liquids after surgery (with in the first 21 days)	No
Secondary	Start of liquid diet		From day of surgery until start of liquid diet after surgery (with in the first 21 days)	No
Secondary	Length of hospital stay		From day of surgery until discharge from surgical ward (with in the first 21 days)	No