Small Bowel Obstruction and Surgery | NCT03826251

Studies
Small Bowel Obstruction and Surgery

NCT03826251

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Feb 1, 2019Actual

Enrollment

190

Phase

Not provided

Conditions

Acute Small Intestine Obstruction

Interventions

Nasogastric tube removal

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Jun 1, 2018Actual

First Submitted Date

Jan 30, 2019

First Submission Date that Met QC Criteria

Jan 30, 2019

First Posted Date

Feb 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2019

Last Update Posted Date

Feb 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

190

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasogastric tube removal	Procedure	Nasogastric tube was removed immediately after surgery	Non systematic nasogastric tube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative morbidity	morbidity classified according to Dindo Clavien classification	within 30 days

Secondary Outcomes

Measure	Description	Time Frame
Nasogastric tube replacement	nasogastric tube replacement after removal	within 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

All patients undergoing surgery for adhesive small bowel obstruction in the CHU of Angers between January 1, 2014 and December 31, 2017

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided