Survival and PN Dependence in SBS Patients | NCT06102668

Studies
Survival and PN Dependence in SBS Patients

NCT06102668

Sponsor

The First Affiliated Hospital of University of Science and Technology of China

Status

Completed

Last Update Posted

Oct 26, 2023Actual

Enrollment

173Actual

Phase

Not provided

Conditions

Short Bowel Syndrome

Interventions

Not provided

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

Oct 2023

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, 2012Actual

Primary Completion Date

Jan 1, 2019Actual

Completion Date

Jan 1, 2019Actual

First Submitted Date

Oct 21, 2023

First Submission Date that Met QC Criteria

Oct 21, 2023

First Posted Date

Oct 26, 2023Actual

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

Oct 21, 2023

Last Update Posted Date

Oct 26, 2023Actual

Name	Class
Jinling Hospital, China	OTHER

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

Short bowel syndrome (SBS) is a rare condition resulting from the loss of portions of the small intestine, and can cause a spectrum of metabolic and physiologic disturbances.The objective of this study was to determine the longterm survival and parenteral nutrition dependence of adult patients with SBS.

Detailed Description

Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition resulting from the loss of portions of the intestine, typically because of extensive surgical resection or loss of intestinal function. Patients with SBS often stuffer from intestinal insufficiency or intestinal failure because they are unable to maintain fluid and nutrient balances on a normal diet. SBS can cause various metabolic and physiologic disturbances. Although parenteral nutrition is a life-saving measure for many patients with SBS, patients with SBS is associated with decreased survival and parenteral nutrition (PN) dependence. Few studies have reported the survival and PN dependence in adult SBS patients in China.

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

173Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	Survival rate in patients with SBS	2012/1/1-2019/1/1
Parenteral nutrition dependence	Parenteral nutrition dependence in patients with SBS	2012/1/1-2019/1/1

Secondary Outcomes

Measure	Description	Time Frame
Risk factors	Risk factors of mortality and parenteral dependence in patients with SBS	2012/1/1-2019/1/1
Cause of death	Cause of death in patients with SBS at the end of follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients diagnosed with SBS.

Exclusion Criteria:

age <18 years; patients with active malignant tumors.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with SBS caused by extensive bowel resection with a remnant small intestine length of <200cm.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JIANFENG GONG, M.D.	Jinling Hospital, China	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012778	Short Bowel Syndrome

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided