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Hernia-Prophylaxis in Acute Care Surgery H-PACS

NCT ID: NCT03090022

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-10-05

Brief Summary

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Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. Patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. Among this population the incidence of incisional hernia in patients undergoing emergency surgery varies between 33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal incarceration, chronic discomfort, pain, and reoperation and typically require implantation of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up to 44%.

The gold standard for abdominal wall closure during elective and emergency operations is a running slowly absorbable suture. In the elective situation it has been shown that prophylactic mesh implantation in high risk patients reduced the incidence of incisional hernia significantly.

The investigators and others have shown that mesh implantation in patients undergoing emergency laparotomy or in contaminated abdominal cavities are safe .

With a randomized controlled trial the investigators now aim to compare the incidence of incisional hernia after prophylactic mesh implantation versus standard of care in patients requiring emergency laparotomy.

Detailed Description

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Conditions

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Incisional Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mesh implantation

Prior to closure of the abdominal wall a mesh will be implanted in a standardized fashion

Group Type ACTIVE_COMPARATOR

Strattice

Intervention Type PROCEDURE

Intra-abdominally Fixation

Single running suture of abdominal fascia

The closure of the abdominal wall a Standard technique will be applied using a running suture

Group Type ACTIVE_COMPARATOR

Single running suture of abdominal fascia

Intervention Type PROCEDURE

Intra-abdominal suture

Interventions

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Strattice

Intra-abdominally Fixation

Intervention Type PROCEDURE

Single running suture of abdominal fascia

Intra-abdominal suture

Intervention Type PROCEDURE

Other Intervention Names

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Acellular porcine dermal mesh

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing emergency midline laparatomy
* Emergency laparoscopy with expected conversion to midline laparatomy
* Written informed consent

Exclusion Criteria

* ASA ≥5
* Septic shock
* Pregnant women
* Prior mesh Implantation
* Known sensitivity for porcine material or Polysorbate 20
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guido Beldi, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Inselspital Berne

Locations

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Dep. of Visceral and transplant surgery, Berne University Hospital

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2016-02212

Identifier Type: -

Identifier Source: org_study_id