Predicting Abdominal Reoperation | NCT05516420

Studies
Predicting Abdominal Reoperation

NCT05516420

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Aug 25, 2022Actual

Enrollment

72,270Actual

Phase

Not provided

Conditions

Surgery
Abdominal Adhesion

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

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

Jun 1, 2009Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Aug 1, 2022Actual

First Submitted Date

Aug 17, 2022

First Submission Date that Met QC Criteria

Aug 24, 2022

First Posted Date

Aug 25, 2022Actual

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

Aug 24, 2022

Last Update Posted Date

Aug 25, 2022Actual

Name	Class
NHS Research Scotland	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

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

72,270Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with first abdominal surgery in Scotland between 2009 and 2011		Patients with first abdominal surgery in Scotland between 2009 and 2011

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with an abdominal reoperation in the study cohort	Number of patients undergoing a reoperation after abdominal surgery	within 5 years postoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.

Exclusion Criteria:

Positive history for abdominal surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients undergoing first abdominal or pelvic surgery between June 1st 2009 and June 30th 2011 in Scotland.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

The data that support the findings of this study are available from the Scottish National Health Service (NHS). Restrictions apply to the availability of these data, which were used under license for this study. Data derived from the analysis are available from the authors with the permission of the Scottish NHS.

The used repository was the Safe Haven (https://shs.epcc.ed.ac.uk/2fa/scotnsh.html) from the NHS.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 27, 2024
Reset	Jan 30, 2025