Indicators of Anastomotic Leak After Colorectal Surgery | NCT06156358

Studies
Indicators of Anastomotic Leak After Colorectal Surgery

NCT06156358

Sponsor

King Abdulaziz University

Status

Completed

Last Update Posted

Dec 5, 2023Actual

Enrollment

441Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

No intervention

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

Nov 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, 2015Actual

Primary Completion Date

Dec 30, 2022Actual

Completion Date

Jul 3, 2023Actual

First Submitted Date

Nov 26, 2023

First Submission Date that Met QC Criteria

Nov 26, 2023

First Posted Date

Dec 5, 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

Nov 26, 2023

Last Update Posted Date

Dec 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

We reviewed the patient underwent colorectal surgery with anastomosis and identified patients with anastomotic leak. Then we started to figure out what blood investigation could be related to anastomotic leak.

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

441Actual

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of blood investigations in detecting anastomotic leak		JAN 2015 - DEC 2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient underwent colorectal surgery with anastomosis

Exclusion Criteria:

Patient has no colon or rectum as part of anastomosis
Patient with more than one procedure within 6 month

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients underwent abdominal surgery with colon or rectum anastomosis

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data will provided upon reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided