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Completed

NCT Number: NCT02305082

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.

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Key information

Conditions

HERNIA, VENTRAL Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital

Copenhagen NV, Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fast-track group

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.

Primary outcomes

  1. 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].

Secondary outcomes

  1. 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).

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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)

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2014
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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