Effects of Chewing Gum Against Postoperative Ileus

Pancreas Neoplasm Clinical Trial

Official title:

The Use of Non-pharmacological Agent to Accelerate Gastrointestinal Recovery in Patients Undergoing Pancreatic Head Resection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04768660
• Other study ID #: chewing gum postoperative
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 14, 2021
• Est. completion date: May 2023

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: andrew mokbel
• Phone: 01090981160
• Email: andrew.sawers55[@]gmail.com
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: May 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.

Exclusion Criteria:

• 2. Ongoing treatment for mental disease 3. Diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function 4. Ongoing abuse of alcohol or other drugs 5. Previously known allergies to the content of chewing gum 6. Additional surgery after primary surgery.

Related Conditions & MeSH terms

• Pancreas Neoplasm
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

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)
Primary	Length of hospital stay	Time Frame: From day of surgery until discharge from surgical ward	(with in the first 21 days) ]