Influence of Gum Chewing on Postoperative Bowel Activity After Complete Staging Surgery for Gynecological Malignancies

Postoperative ileus can cause the accumulation of secretions and gas, resulting in nausea, vomiting and abdominal distension and pain. Prolonged paralytic ileus is one of the commonest reasons for delayed recovery and discharge from hospital following abdominal surgery. Advances in surgical techniques and peri-operative management such as the use of laparoscopic surgery, thoracic epidural analgesia, early postoperative feeding and mobilization, amongst others, have been shown to help in the resolution of postoperative ileus.

Chewing gum, as a proxy for sham feeding, may accelerate the motility of the GI tract by stimulating the cephalic phase of digestion and eliciting the release of multiple promotility GI hormones. A number of small controlled studies evaluating the effect of chewing gum on postoperative intestinal recovery in patients undergoing colorectal surgery have been conducted. Decreased time for bowel function recovery and decreased hospital length of stay have not been consistently documented, possibly owing to the insufficient power of existing studies and study design issues. In addition, all previous studies have been limited by their use of sugarfree gum, containing known motility agents (eg, sorbitol).

In this study, gum chewing was studied for its effect on women with surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer.

Study Overview

• Status: Unknown
• Conditions: Postoperative Ileus
• Intervention / Treatment: Drug: gum

• Study Type: Interventional
• Enrollment (Anticipated): 152
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Tepecik
    • İzmir, Tepecik, Turkey, 35120
      • Recruiting
      • Izmir Tepecik Training and Research Hospital
      • Contact: Egmen Ertas, drertas@gmail.com; Phone Number: 90 232 449 49 49; Email: drertas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women who would undergo surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer were assessed for eligibility.

Exclusion Criteria:

• women who had thyroid diseases, inflammatory bowel disease, complaints of chronic constipation (defined as two or less bowel movements per week), had a history of prior abdominal bowel surgery, abdominal radiation, or neoadjuvant chemotherapy,
• need for intensive care more that 24 hours postoperatively, had nasogastric tube drainage beyond the first postoperative morning bowel anastomosis in relation to their operation during the surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: chewing gum; Gum type was standardized with all subjects receiving sugar-free peppermint-flavored gum. The patients in the chewing gum group, gum chewing began the morning of postoperative day 1. Patients chewed gum (one stick) 3 times daily in the morning, afternoon, and evening at least 5 min. The administration of the therapy was implemented by ward nursing staff and recorded in the patients file. All gum-chewing patients completed their course of gum chewing until bowel function.	Drug: gum; gum
NO_INTERVENTION: control group; no gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative flatus pass time	The main outcome variable of the study was postoperative flatus pass time (hours from end of operation). Participants will be followed for the duration of the flatus pass time, an expected average of 48 hours	an expected average of 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks	an expected average of 3 weeks
gastrointestinal disturbance	gastrointestinal disturbance such as nausea, abdominal cramping, abdominal distension, rate of vomiting	an expected average of 3 weeks
time to first bowel movement	time to first bowel movement (hours from end of operation).Participants will be followed for time to first bowel movement, an expected average of 48 hours hours from end of operation	an expected average of 48 hours hours from end of operation
Time to first defaecation	The main outcome variable of the study was postoperative flatus pass time (hours from end of operation).Participants will be followed for the duration of the first defaecation time, an expected average of 72 hours	an expected average of 72 hours

Collaborators and Investigators

• Sponsor: Erzincan Military Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): April 1, 2013
• Study Completion (ANTICIPATED): April 1, 2013

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (ESTIMATE): April 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 18, 2013
• Last Update Submitted That Met QC Criteria: April 17, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: postoperative; gynecological malignancies; bowel activity; gum chewing
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: gungorduk14