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

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01835119
• Other study ID #: gungorduk14
• Status: Recruiting
• Phase: Phase 4
• First received: April 10, 2013
• Last updated: April 17, 2013
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Erzincan Military Hospital
• Contact: Egemen Ertas, M.D
• Phone: 90 232 449 49 49
• Email: drertas[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTurkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

Drug:
• gum
gum

Locations

Country	Name	City	State
Turkey	Izmir Tepecik training and research hospital	Izmir	Tepecik

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan Military Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	gastrointestinal disturbance	gastrointestinal disturbance such as nausea, abdominal cramping, abdominal distension, rate of vomiting	an expected average of 3 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes