Clinical Trial: Fast-track Giant Ventral Hernia Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Fast-track Giant Ventral Hernia Repair

Brief Summary: 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 Summary:

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.


Sponsor: Bispebjerg Hospital

Current Primary Outcome: Time to discharge [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 72 hours ]

Time from surgery to discharge [Hours].


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Bispebjerg Hospital

Dates:
Date Received: November 11, 2014
Date Started: December 2014
Date Completion:
Last Updated: September 3, 2015
Last Verified: September 2015