Case Report in Complications After Laparoscopic Transabdo... | NCT05952791

Studies
Case Report in Complications After Laparoscopic Transabdominal Preperitoneal Groin Hernia Repair Using LiquiBandFIX8®

NCT05952791

Sponsor

Kepler University Hospital

Status

Completed

Last Update Posted

Jul 19, 2023Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Groin Hernia

Interventions

Surgery

Countries

Austria

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

Jul 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 5, 2022Actual

Primary Completion Date

Jan 5, 2022Actual

Completion Date

Jan 5, 2022Actual

First Submitted Date

Jun 7, 2023

First Submission Date that Met QC Criteria

Jul 17, 2023

First Posted Date

Jul 19, 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

Jul 17, 2023

Last Update Posted Date

Jul 19, 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

This an a case report about management and proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair. The patient had anticoagulation due to a mechanical valvula and postoperatively the patient developed a huge hematoma extraperitoneally. Relaparoscopy war performed to identify the problem and check the peritoneal closure.

Detailed Description

This an a case report for proving the strenght and resistance of LiquiBandFIX8® using for peritoneal closure in a laparoscopic transabdominal preperitoneal groin hernia repair (TAPP). The patient had anticoagulation due to a mechanical valvula and postoperatively after TAPP the patient developed a huge hematoma extraperitoneally. The investigatorsperformed relaparoscopy for diagnostic and therapeutic reasons to check stop the bleeding and control the integrety of the peritoneal closure.

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

1Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Other	Laparoscopic transabdominal preperitoneal (TAPP) groin hernia repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Strongness of LiquiBandFIX8®	Mesh dislocation, mesh damage (yes/no)	2 weeks
Hemtoma	intraperitoneal blood (yes/no)	2 weeks
Strongness of LiquiBandFIX8®	peritoneal leakage, peritoneal damage (yes/no)	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Retrospective case report of one patient undergoing laparoscopic groin hernia repair

Exclusion criteria:

- not applicable (retrospective)

Accepts Healthy Volunteers

Yes

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

Retrospective case report of one patient

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandra Raab, MD	Kepler University Hospital Linz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kepler University Hospital		Linz	Upper Austria	4020	Austria

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

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided