Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05296967
Other study ID # 2021_A03140_41
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date May 1, 2023

Study information

Verified date March 2022
Source University Hospital, Angers
Contact Aurélien Venara, MD,PhD
Phone 0033241353618
Email auvenara@chu-angers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 128
Est. completion date May 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
chewing
patients are asked to chew chewing gum X 3/ day

Locations

Country Name City State
France University Hospital aof Angers Angers

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Angers Centre Hospitalier de Cholet

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
collected each day until the end of the POI, assessed up to day 21
See also
  Status Clinical Trial Phase
Recruiting NCT04205058 - Coffee After Pancreatic Surgery N/A
Completed NCT02232893 - Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy Phase 2
Not yet recruiting NCT05001763 - Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy Phase 2
Active, not recruiting NCT04547868 - Can Coffee/Caffeine Improve Post-Operative Gastrointestinal Recovery N/A
Completed NCT02815956 - Tibial Nerve Stimulation and Postoperative Ileus N/A
Completed NCT02947269 - Prucalopride in Postoperative Ileus Phase 3
Recruiting NCT05512741 - Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery
Recruiting NCT04675606 - Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies N/A
Completed NCT02161367 - Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery Phase 4
Completed NCT01956643 - Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation N/A
Completed NCT00464425 - Electroacupuncture for Postoperative Ileus After Laparoscopic Colorectal Surgery Phase 3
Completed NCT00402961 - Trial of Acupuncture for Reduction of Post-Colectomy Ileus Phase 2
Terminated NCT04100265 - ANTERO-5: Gastric Motility in Postoperative Ileus N/A
Recruiting NCT04090073 - Electroacupuncture Combined With Fast-track Perioperative Program for Laparoscopic Colorectal Surgery N/A
Recruiting NCT03222557 - Electroacupuncture for Postoperative Ileus After Laparoscopic Surgery for Mid and Low Rectal Cancer N/A
Withdrawn NCT02261454 - RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children N/A
Completed NCT02639728 - The Effect of Coffee Consumption in Enhancing Recovery of Bowel Function Following Colorectal Surgery. N/A
Completed NCT02004652 - Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery Phase 2
Completed NCT00509327 - Randomized Clinical Trial of Bisacodyl Versus Placebo on Postoperative Bowel Motility in Elective Colorectal Surgery Phase 4
Completed NCT03097900 - Does Caffeine Enhance Bowel Recovery After Colorectal Surgery? Phase 2