NCT01394094

Brief Summary

Gum chewing can promotes the return bowel function after gynecologic surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 14, 2011

Status Verified

July 1, 2011

Enrollment Period

2.3 years

First QC Date

July 13, 2011

Last Update Submit

July 13, 2011

Conditions

Recovery of Bowel Function, Due to Gum Chewing

Keywords

Gum chewingBowel functionbenign gynecologic surgery

Outcome Measures

Primary Outcomes (1)

  • Time to first flatus

    Up to 7 days after surgery

Secondary Outcomes (6)

  • Incidence and severity of postoperative nausea, vomiting and abdominal discomfort

    Up to 7 days after surgery

  • Incidence of postoperative complications

    Up to 7 days after surgery

  • Time to first regular diet

    Up to 7 days after surgery

  • Time to first defecation

    Up to 7 days after surgery

  • Hospital stay

    Up to 7 days after surgery

  • +1 more secondary outcomes

Study Arms (2)

Gum Chewing

EXPERIMENTAL

Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule

Behavioral: Gum chewing

Conventional

NO INTERVENTION

Conventional postoperative feeding schedule

Interventions

Gum chewingBEHAVIORAL

Gum chewing(30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in the addition to conventional postoperative feeding schedule

Also known as: Sugar free and calcium free gum
Gum Chewing

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing abdominal surgery for benign gynecologic conditions at Maharaj Nakorn Chiang Mai hospital

You may not qualify if:

  • Perioperative hyperalimentation
  • Recent chemotherapy (within 3 weeks before surgery)
  • Previous bowel surgery
  • Inflammatory bowel disease
  • Previous abdominal or pelvic radiation
  • Need for immediate postoperative endotracheal intubation
  • Need for postoperative admission to intensive care unit
  • Undergoing emergency surgery with oral intake of fluid or food with in 4 hours before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Chiang Mai University

Amphoe Muang, Chiang Mai, 50200, Thailand

Location

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Manatsawee - Manopunya, MD

    Chiang Mai University, Thailand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manatsawee Manopunya, MD

CONTACT

66-89-6324916manatsawee.m@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 14, 2011

Study Start

July 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 14, 2011

Record last verified: 2011-07

Locations

TH(1)