Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery

NCT ID: NCT01394094

Last Updated: 2011-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-10-31

Brief Summary

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

Detailed Description

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Following abdominal surgery for treatment of benign gynecologic surgery, paralytic ileus may be develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion. This study will be evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complication, and patients's satisfaction.

Conditions

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Recovery of Bowel Function, Due to Gum Chewing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Gum Chewing

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

Group Type EXPERIMENTAL

Gum chewing

Intervention Type BEHAVIORAL

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

Conventional

Conventional postoperative feeding schedule

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gum chewing

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Sugar free and calcium free gum

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Chiang Mai University

Principal Investigators

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Manatsawee - Manopunya, MD

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University, Thailand

Locations

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Faculty of Medicine, Chiang Mai University

Amphoe Muang, Chiang Mai, Thailand

Site Status

Countries

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Thailand

Central Contacts

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Manatsawee Manopunya, MD

Role: CONTACT

66-89-6324916

Facility Contacts

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Manatsawee Manopunya, MD

Role: primary

66-89-6324916

Other Identifiers

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10OCT010402

Identifier Type: -

Identifier Source: org_study_id

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