Gum Chewing After Gynecologic Laparoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Husslein Heinrich, MD, Klinikum Klagenfurt am Wörthersee
ClinicalTrials.gov Identifier:
NCT01549353
First received: February 23, 2012
Last updated: December 1, 2012
Last verified: December 2012

February 23, 2012
December 1, 2012
July 2011
August 2012   (final data collection date for primary outcome measure)
Time to return to active bowel movements [ Time Frame: participants will be followed for the duration of hospital stay ] [ Designated as safety issue: No ]
First active bowel movement is defined as time from operation until first passage of flatus. Time until first defecation will also be measured.
Same as current
Complete list of historical versions of study NCT01549353 on ClinicalTrials.gov Archive Site
  • patient satisfaction with postoperative gum chewing [ Time Frame: participants will be followed for the duration of the hospital stay ] [ Designated as safety issue: No ]
    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)
  • Number of participants with adverse events [ Time Frame: participants will be followed for the duration of hospital stay ] [ Designated as safety issue: Yes ]
    All problems that are linked to postoperative gum chewing will be recorded (e.g. vomiting, aspiration,...)
Same as current
Not Provided
Not Provided
 
Gum Chewing After Gynecologic Laparoscopy
Does Gum Chewing After Gynecologic Laparoscopy Stimulate Earlier Return of Bowel Motility?

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Postoperative Care
Behavioral: gum chewing
Experimental: chewing gum
Intervention: Behavioral: gum chewing
Husslein H, Franz M, Gutschi M, Worda C, Polterauer S, Leipold H. Postoperative gum chewing after gynecologic laparoscopic surgery: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):85-90. doi: 10.1097/AOG.0b013e3182983e92.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all gynecologic laparoscopic surgery
  • normal level of CA 125 postmenopausal

Exclusion Criteria:

  • loose teeth
  • chronic obstipation
  • laparotomy
  • operations longer then 3 h
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01549353
A 02/10
No
Husslein Heinrich, MD, Klinikum Klagenfurt am Wörthersee
Klinikum Klagenfurt am Wörthersee
Not Provided
Not Provided
Klinikum Klagenfurt am Wörthersee
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP