Fast-track Giant Ventral Hernia Repair

NCT ID: NCT02305082

Last Updated: 2015-09-07

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

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-07-31

Brief Summary

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The implementation of an enhanced recovery pathway after giant ventral hernia repair, including preoperative high-dose steroid is examined prospectively and compared with a group of historic controls.

Detailed Description

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All patients operated on for a large incisional hernia are treated according to the study protocol. Patients are given high-dose glucocorticoid preoperative and the aim is to discharge patients at postoperative day 3.

Morbidity, length of stay, pain, nausea and pulmonary function are among registered outcomes compared with a historic control group.

Conditions

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Hernia, Ventral

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fast-track group

Patients treated according to the enhanced recovery pathway. This group is examined prospectively.

Fast-track group

Intervention Type OTHER

Enhanced recovery after surgery pathway. Postoperatively, a set of well-defined discharge criteria will be assessed daily at 9:00 and 15:00, as well as pain, nausea, time to flatus, saturation and drain production.

Control group

Patients treated according to the historic recovery pathway. This group is examined retrospectively.

No interventions assigned to this group

Interventions

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Fast-track group

Enhanced recovery after surgery pathway. Postoperatively, a set of well-defined discharge criteria will be assessed daily at 9:00 and 15:00, as well as pain, nausea, time to flatus, saturation and drain production.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Horizontal fascia defect \> 10 cm on computed tomography scan
* Planned elective open incisional hernia repair

Exclusion Criteria

* Known allergy against glucocorticoid treatment
* Insulin-treated diabetes
* Gastric ulcer diagnosed within four weeks preoperative
* Steroid-treated immune disease
* Planned intestinal anastomosis concomitant to hernia repair
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristian Kiim Jensen

MD, PHD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristian K Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen NV, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Fast-track-hernia-bbh

Identifier Type: -

Identifier Source: org_study_id

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