Transcriptomic Analysis of Incisional Hernia Based on Hig... | NCT06366581

Studies
Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology

NCT06366581

Sponsor

Fudan University

Status

Completed

Last Update Posted

Apr 16, 2024Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Incisional Hernia
Extracellular Matrix Alteration

Interventions

Transcriptomic analysis

Countries

China

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

Mar 2024

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

Mar 1, 2023Actual

Primary Completion Date

Sep 1, 2023Actual

Completion Date

Mar 1, 2024Actual

First Submitted Date

Mar 7, 2024

First Submission Date that Met QC Criteria

Apr 14, 2024

First Posted Date

Apr 16, 2024Actual

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

Apr 14, 2024

Last Update Posted Date

Apr 16, 2024Actual

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

This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Then genes analyzed by Gene Ontology, protein interactions, and signaling pathway enrichment using the expression matrix.

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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IH group		Patients who underwent incisional hernia repair were defined as the experimental group (labelled as the IH group)	Diagnostic Test: Transcriptomic analysis
NC group		patients who underwent laparoscopic cholecystectomy were defined as the control group (labelled as the NC group)	Diagnostic Test: Transcriptomic analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcriptomic analysis	Diagnostic Test	high-throughput sequencing technology	IH group NC group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the gene expression list	the gene expression list	2023.3-2023.9

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.18 to 75 years 2.diagnosed with incisional hernia 3.normal tumour markers 4.elective surgery patients.

Exclusion Criteria:

patients with vital organ failure (heart liver, lung, kidney and others)
malignant tumors not been completely relieved by active treatment,
patients who have psychiatric diseases or comprehension disorders.
patients with metabolic disease involving connective tissue collagen.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent incisional hernia repair were defined as the experimental group (labelled as the IH group), and patients who underwent laparoscopic cholecystectomy were defined as the control group (labelled as the NC group).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hua Dong Hospital Affiliated to Fu Dan University		Shanghai			China

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
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided