Influence of Gum Chewing on Postoperative Bowel Activity After Complete Staging Surgery for Gynecological Malignancies

NCT ID: NCT01835119

Last Updated: 2013-04-18

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

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

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Postoperative ileus can cause the accumulation of secretions and gas, resulting in nausea, vomiting and abdominal distension and pain. Prolonged paralytic ileus is one of the commonest reasons for delayed recovery and discharge from hospital following abdominal surgery. Advances in surgical techniques and peri-operative management such as the use of laparoscopic surgery, thoracic epidural analgesia, early postoperative feeding and mobilization, amongst others, have been shown to help in the resolution of postoperative ileus.

Chewing gum, as a proxy for sham feeding, may accelerate the motility of the GI tract by stimulating the cephalic phase of digestion and eliciting the release of multiple promotility GI hormones. A number of small controlled studies evaluating the effect of chewing gum on postoperative intestinal recovery in patients undergoing colorectal surgery have been conducted. Decreased time for bowel function recovery and decreased hospital length of stay have not been consistently documented, possibly owing to the insufficient power of existing studies and study design issues. In addition, all previous studies have been limited by their use of sugarfree gum, containing known motility agents (eg, sorbitol).

In this study, gum chewing was studied for its effect on women with surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer.

Detailed Description

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Conditions

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Postoperative Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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chewing gum

Gum type was standardized with all subjects receiving sugar-free peppermint-flavored gum.

The patients in the chewing gum group, gum chewing began the morning of postoperative day 1. Patients chewed gum (one stick) 3 times daily in the morning, afternoon, and evening at least 5 min. The administration of the therapy was implemented by ward nursing staff and recorded in the patients file. All gum-chewing patients completed their course of gum chewing until bowel function.

Group Type EXPERIMENTAL

gum

Intervention Type DRUG

gum

control group

no gum

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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gum

gum

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women who would undergo surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer were assessed for eligibility.

Exclusion Criteria

* women who had thyroid diseases, inflammatory bowel disease, complaints of chronic constipation (defined as two or less bowel movements per week), had a history of prior abdominal bowel surgery, abdominal radiation, or neoadjuvant chemotherapy,
* need for intensive care more that 24 hours postoperatively, had nasogastric tube drainage beyond the first postoperative morning bowel anastomosis in relation to their operation during the surgery
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Erzincan Military Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kemal GUNGORDUK

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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İzmir Tepecik training and research hospital

Izmir, Tepecik, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Egemen Ertas, M.D

Role: CONTACT

90 232 449 49 49

Aykut Ozdemir, M.D

Role: CONTACT

90 232 449 49 49

Facility Contacts

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Egmen Ertas, [email protected]

Role: primary

90 232 449 49 49

Other Identifiers

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gungorduk14

Identifier Type: -

Identifier Source: org_study_id

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