Clinical trial NCT02319512: Effects of Chewing Gum Against Postoperative Ileus
Official title: Effects of Chewing Gum Against Postoperative Ileus After Pancreaticoduodenectomy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Postoperative Ileus
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: First flatus after surgery
timeFrame: From day of surgery until first postoperative flatus (with in the first 21 days)
measure: First stool after surgery
timeFrame: From day of surgery until first stool (with in the first 21 days)
Secondary outcomes:
measure: Start of clear fluids
timeFrame: From day of surgery until start of clear liquids after surgery (with in the first 21 days)
measure: Start of liquid diet
timeFrame: From day of surgery until start of liquid diet after surgery (with in the first 21 days)
measure: Length of hospital stay
timeFrame: From day of surgery until discharge from surgical ward (with in the first 21 days)
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Health and Care Sciences, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden
name: Kristin Falk, PhD
role: STUDY_DIRECTOR
affiliation: Department of Gastrosurgical Research and Education, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden
name: Monika Fagevik Olsén, PhD
role: STUDY_DIRECTOR
affiliation: Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden
name: Kristofer Bjerså, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
name: Thomas Andersson, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersson T, Bjersa K, Falk K, Olsen MF. Effects of chewing gum against postoperative ileus after pancreaticoduodenectomy--a randomized controlled trial. BMC Res Notes. 2015 Feb 10;8:37. doi: 10.1186/s13104-015-0996-0.