NCT01549353

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 4, 2012

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

February 23, 2012

Last Update Submit

December 1, 2012

Conditions

Postoperative Care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • patient satisfaction with postoperative gum chewing

    participants will be followed for the duration of the hospital stay

  • Number of participants with adverse events

    participants will be followed for the duration of hospital stay

Study Arms (1)

chewing gum

EXPERIMENTAL
Behavioral: gum chewing

Interventions

gum chewingBEHAVIORAL
chewing gum

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • loose teeth
  • chronic obstipation
  • laparotomy
  • operations longer then 3 h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Klagenfurt am Woerthersee

Klagenfurt, Carinthia, 9020, Austria

Location

Related Publications (1)

  • 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.

    PMID: 23743472DERIVED

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 23, 2012

First Posted

March 9, 2012

Study Start

July 1, 2011

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

December 4, 2012

Record last verified: 2012-12

Locations

AU(1)