Prevention of Ileus After Gynecologic Surgery Using Chewing Gum

Aultman Health Foundation

Status: Completed

Conditions: Ileus

Treatments: Other: Standard Post-Op Care; Other: chewing gum - Extra Winterfresh

Study type: Interventional

Funder types: Other

Identifiers

NCT00831246

2008 JMC

2008.03.27.E2

Details and patient eligibility

About

This study will attempt to determine if the use of chewing gum can cause the early return of bowel function after gynecologic surgery.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All female patients 18 years of age or older undergoing surgery for any gynecologic procedure which the peritoneum is entered and general anesthesia is administered.
• Disease State will not affect inclusion in the study. Women with previous surgeries or other medical conditions will be included as will those undergoing an initial operation.

Exclusion criteria

• Patient deemed legally incompetent to sign their own consent
• Women under the age of 18
• Patients lacking their own or a false set of teeth

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

1

Experimental group

Description:

Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.

Treatment:

Other: chewing gum - Extra Winterfresh

2

Sham Comparator group

Description:

Patients are given standard post-op care with clear liquid diet as tolerated .

Treatment:

Other: Standard Post-Op Care