Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus

NCT ID: NCT05296967

Last Updated: 2025-10-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2025-07-15

Brief Summary

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Postoperative ileus (POI) is a serious complication after surgery. While it complicates all type of surgery, it is more frequent after abdominal surgery (especially bowel or colorectal surgery).

Many studies aim to reduce the occurence of POI without efficiency. The aim of this study is to assess the efficiency of the vagal stimulation, by the mean of chewing, to reduce the duration of POI.

Detailed Description

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Conditions

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Postoperative Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chewing gum

POI patients are asked to chew 20 minutes x2/ day

Group Type EXPERIMENTAL

chewing

Intervention Type BEHAVIORAL

patients are asked to chew chewing gum X 3/ day

No chewing

POI patients receive no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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chewing

patients are asked to chew chewing gum X 3/ day

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* patients undergoing colorectal surgery or small bowel surgery
* elective or in emergency
* open surgery or laparoscopy
* diagnosis of POI
* indication of fasting or nasogastric tube placement

Exclusion Criteria

* contra-indication of chewing
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Cholet

OTHER

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital aof Angers

Angers, , France

Site Status

CH Château Gontier

Château-Gontier, , France

Site Status

CH Cholet

Cholet, , France

Site Status

CHD Vendée

La Roche-sur-Yon, , France

Site Status

CH Laval

Laval, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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2021_A03140_41

Identifier Type: -

Identifier Source: org_study_id

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