Gum Chewing After Gynecologic Laparoscopy

Postoperative Care Clinical Trial

Official title:

Does Gum Chewing After Gynecologic Laparoscopy Stimulate Earlier Return of Bowel Motility?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549353
• Other study ID #: A 02/10
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: December 1, 2012
• Start date: July 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: Klinikum Klagenfurt am Wörthersee
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Gum chewing has been reported to stimulate bowel motility after open surgery, such as cesarean section and other abdominal surgeries. In general, after laparoscopic surgery problems with reduced bowel motility are not as common as after open surgery. In this study the investigators test the hypothesis that gum chewing is enhancing rapid return of bowel motility after gynecologic laparoscopic surgery. Further the investigators study patient satisfaction and potential side effects of postoperative gum chewing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• all gynecologic laparoscopic surgery

• normal level of CA 125 postmenopausal

Exclusion Criteria:

• loose teeth

• chronic obstipation

• laparotomy

• operations longer then 3 h

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Postoperative Care

Intervention

Behavioral:
• gum chewing

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt am Woerthersee	Klagenfurt	Carinthia

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Klagenfurt am Wörthersee

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to return to active bowel movements	First active bowel movement is defined as time from operation until first passage of flatus. Time until first defecation will also be measured.	participants will be followed for the duration of hospital stay	No
Secondary	patient satisfaction with postoperative gum chewing	Satisfaction will be measured with a visual analog scale (1 participant would never chew gum postoperatively again - 10 participant would always like to chew gum postoperatively)	participants will be followed for the duration of the hospital stay	No
Secondary	Number of participants with adverse events	All problems that are linked to postoperative gum chewing will be recorded (e.g. vomiting, aspiration,...)	participants will be followed for the duration of hospital stay	Yes