NCT03090022

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

3.6 years

First QC Date

March 20, 2017

Last Update Submit

October 25, 2021

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (2)

  • Number of incidence of death

    follow-up

    up to 18 months

  • Number of patients with hernia free survival

    follow-up

    up to 18 months

Secondary Outcomes (8)

  • Number of patients with postoperative fascial dehiscence

    30 days

  • Number of postoperative mortality

    90 days

  • Number of surgical site infections postoperative

    30 days

  • Number of postoperative intestinal fistulas

    30 days

  • Number of small bowel obstructions

    18 months

  • +3 more secondary outcomes

Study Arms (2)

Mesh implantation

ACTIVE COMPARATOR

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

Procedure: Strattice

Single running suture of abdominal fascia

ACTIVE COMPARATOR

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

Procedure: Single running suture of abdominal fascia

Interventions

StratticePROCEDURE

Intra-abdominally Fixation

Also known as: Acellular porcine dermal mesh
Mesh implantation
Single running suture of abdominal fasciaPROCEDURE

Intra-abdominal suture

Single running suture of abdominal fascia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • ASA ≥5
  • Septic shock
  • Pregnant women
  • Prior mesh Implantation
  • Known sensitivity for porcine material or Polysorbate 20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Visceral and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Incisional Hernia

Interventions

strattice

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Guido Beldi, Prof. Dr.

    Inselspital Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 24, 2017

Study Start

March 1, 2017

Primary Completion

October 5, 2020

Study Completion

October 5, 2020

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations

CH(1)