Fast-track Giant Ventral Hernia Repair

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.

Study Overview

• Status: Completed
• Conditions: Hernia, Ventral
• Intervention / Treatment: Other: Fast-track group

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Copenhagen NV, Copenhagen, Denmark, 2400
      • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are scheduled to undergo elective incisional hernia repair.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fast-track group; Patients treated according to the enhanced recovery pathway. This group is examined prospectively.	Other: 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.
Control group; Patients treated according to the historic recovery pathway. This group is examined retrospectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discharge	Time from surgery to discharge [Hours].	Participants will be followed for the duration of hospital stay, an expected average of 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No fatigue, 5 = Exhausted).	Preoperative and for the duration of hospital stay, an expected average of 3 days
Pain from supine to standing	Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No pain, 5 = Intolerable pain)	Preoperative and for the duration of hospital stay, an expected average of 3 days
Pain when walking 6 meters	Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No pain, 5 = Intolerable pain)	Preoperative and for the duration of hospital stay, an expected average of 3 days
Nausea	Preoperative and twice daily (9 and 15) postoperative. Measured by a numerical rating scale (1 = No nausea, 5 = Intolerable nausea)	Preoperative and for the duration of hospital stay, an expected average of 3 days
Time to bowel function	The time to bowel function [hours] will be registered for each participant	For the duration of postoperative hospital stay, an expected average of 72 hours
Vomiting episodes	The daily number of vomiting episodes will be registered for each participant	Participants will be followed for the duration of hospital stay, an expected average of 3 days
Continuous transcutaneous saturation	Continuous transcutaneous oxygen saturation (percentage), measured by Pulsox 300i (C) (Konica Minolta, Osaka, Japan)	From surgery to postoperative day 3 at 12 pm
C-reactive protein from venous blood sample	Daily C-reactive protein measured in a venous blood sample.	Preoperative and for the duration of hospital stay, an expected average of 3 days
Ear temperature	Ear temperature (celsius degree) measured daily at 9 and 15.	Preoperative and for the duration of hospital stay, an expected average of 3 days
Detailed reason for not being discharged if criteria are otherwise fulfilled	The reason(s) for participants not being discharged if discharge criteria are otherwise fulfilled.	From surgery and for the duration of hospital stay, an expected average of 3 days
Daily wound drain production	Daily registration of the fluid volume [milliliters] in the wound drains postoperative.	From surgery and for the duration of hospital stay, an expected average of 3 days

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Principal Investigator: Kristian K Jensen, MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: November 11, 2014
• First Submitted That Met QC Criteria: November 27, 2014
• First Posted (Estimate): December 2, 2014

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: Fast-track-hernia-bbh