Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Suspected Appendicitis Clinical Trial

Official title: Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Status Completed

Clinical Trial Summary

To test whether 125 mg preoperative methylprednisolone intravenously can reduce postoperative pain after laparoscopy for suspected appendicitis and to test whether preoperative methylprednisolone can reduce postoperative fatigue, increase quality of sleep, reduce nausea or vomiting, reduce duration of convalescence and increase overall quality of recovery after laparoscopy for suspected appendicitis.

Clinical Trial Description

Patients enrolled are randomized to active substance or placebo approximately 30 minutes prior to skin incision.

Patients are followed for 30 days postoperative with registration of outcomes on a postoperative questionnaire. Patients are contacted by telephone at every registration time. The primary outcome is also secured over the telephone in case patients do not return their questionnaire.

With a power of 80% and a significance level of 5% we need 64 patients (32 in each arm) to show a 30% reduction in postoperative pain during the first 3 postoperative days with 5 measurements and we need 42 patients (21 in each arm) to show a 15% increase in the QoR-15 during the first 3 postoperative days. With an anticipated loss to follow up of 20% we need 80 patients ( 40 in each arm). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis
• Suspected Appendicitis

• NCT number: NCT02711449
• Study type: Interventional
• Source: Nordsjaellands Hospital
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Completion date: September 2016