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

Sponsor

University Hospital, Angers (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05296967

Collaborator

Centre Hospitalier de Cholet (Other)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus	Behavioral: chewing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficiency of Chewing-gum to Reduce the Duration Postoperative Ileus: a Randomized Controlled Study

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chewing gum POI patients are asked to chew 20 minutes x2/ day	Behavioral: chewing patients are asked to chew chewing gum X 3/ day
No Intervention: No chewing POI patients receive no intervention

Arm

Intervention/Treatment

Experimental: Chewing gum

POI patients are asked to chew 20 minutes x2/ day

Behavioral: chewing

patients are asked to chew chewing gum X 3/ day

No Intervention: No chewing

POI patients receive no intervention

Outcome Measures

Primary Outcome Measures

To assess the efficiency of chewing gum in reducing the duration of POI. POI is defined by the criteria of Vather from the postoperative day 1 up to day 30 [collected each day until the end of the POI, assessed up to day 21]
The duration of POI is the time between the first day of meeting the criteria of Vather to the day of recovery of tolerance of solid food and of exoneration of stool and/or flatus (GI-3 recovery). Patients will be asked to report in their diary the day of tolerance of solid food and of exoneration of stool and/or flatus (GI-3 recovery) after the diagnosis of POI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital aof Angers	Angers		France

Sponsors and Collaborators

University Hospital, Angers
Centre Hospitalier de Cholet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT05296967

Other Study ID Numbers:

2021_A03140_41

First Posted:

Mar 25, 2022

Last Update Posted:

Mar 25, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ileus

Study Results

No Results Posted as of Mar 25, 2022