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Small Bowel Obstruction and Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826251
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:

Postoperative management after small bowel obstruction (SBO) surgery is not consensual and better knowledge of risk factors for postoperative morbidity could help to add evidence of the feasibility of enhanced recovery programs (ERPs).

In elective surgery, ERPs have shown a significant benefit for the patient but this is not performed routinely in emergency surgery due to the difficulty to avoid postoperative nasogastric tube.

The aim was to identify risk factors for postoperative morbidity and for nasogastric tube (NGT) replacement after SBO surgery.


Condition or disease Intervention/treatment
Acute Small Intestine Obstruction Procedure: Nasogastric tube removal

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Study Type : Observational
Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Nasogastric Tube After Small Bowel Obstruction Surgery is Not Mandatory: a Retrospective Cohort Study
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
systematic nasogastric tube
NGT was left systematically after surgery and removed after the first flattus
Non systematic nasogastric tube
Nasogastric tube was removed immediately after surgery and was replaced in case of vomiting
Procedure: Nasogastric tube removal
Nasogastric tube was removed immediately after surgery




Primary Outcome Measures :
  1. postoperative morbidity [ Time Frame: within 30 days ]
    morbidity classified according to Dindo Clavien classification


Secondary Outcome Measures :
  1. Nasogastric tube replacement [ Time Frame: within 30 days ]
    nasogastric tube replacement after removal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients undergoing surgery for adhesive small bowel obstruction in the CHU of Angers between January 1, 2014 and December 31, 2017
Criteria

Inclusion Criteria:

  • Surgical management of Small bowel obstruction due to adhesions

Exclusion Criteria:

  • obstruction not caused by single band adhesion
  • matted adhesions, or if they were less than 18 years old
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03826251    
Other Study ID Numbers: UH Angers 2018/75
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases