Fast-track Giant Ventral Hernia Repair

Hernia, Ventral Clinical Trial

Official title:

Fast-track Giant Ventral Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305082
• Other study ID #: Fast-track-hernia-bbh
• Status: Completed
• Phase: N/A
• First received: November 11, 2014
• Last updated: September 3, 2015
• Start date: December 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Intervention

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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen NV	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No