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Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Primary Purpose

Suspected Appendicitis

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Methylprednisolone

0.9% Saline

About this trial

This is an interventional treatment trial for Suspected Appendicitis focused on measuring acute surgery, laparoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Laparoscopy for suspected appendicitis
Age 18 years or older
American Society of Anesthesiologist (ASA) class I-III.
Gives written and oral consent

Exclusion Criteria:

Known inflammatory bowel disease.
Known autoimmune disease.
Chronic pain patient.
Presumed poor compliance.
Pregnant or breastfeeding.
In systematic treatment with glucocorticoids or other immunosuppressive treatment.
Known renal disease, GFR<30.
Known liver cirrhosis.
Known heart failure, EF<40%.
Known glaucoma.
Known ocular herpes simplex.
Known cushings disease.

Sites / Locations

Nordsjaellands Hospital
Køge Sygehus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylprednisolone

Placebo

Arm Description

125 mg Methylprednisolone intravenously approximately 30 minutes prior to skin incision

0.9% Saline intravenously approximately 30 minutes prior to skin incision

Outcomes

Primary Outcome Measures

Pain at rest during the first 3 postoperative days on a 11-point NRS

Powered to detect 30% reduction, Random regression model (mixed effects model)

Secondary Outcome Measures

Pain when coughing during the first 3 postoperative days on a 11-point NRS

Random regression model (mixed effects model)

Fatigue during the first 3 postoperative days on a 11-point NRS

Random regression model (mixed effects model)

Sleep during the first 3 postoperative days on a 11-point NRS

QoR-15 during the first 3 postoperative days

Powered to detect 15% increase,

Incidence of postoperative nausea or vomiting during the first postoperative day

Pain at rest after POD3 on a 11-point NRS

Pain when coughing after POD3 on a 11-point NRS

Fatigue after POD3 on a 11-point NRS

Sleep after POD3 on a 11-point NRS

QoR-15 after POD 3

Mobilization during the first postoperative day on a 4-point likert scale

Resumption of occupational activity

Number of days from surgery until resumption of occupational activities

Resumption of recreational activity

Number of days from surgery until resumption of recreational activities

Duration of convalescence

Number of days from surgery until resumption of both occupational and recreational activities

Adverse events according to GCP guidelines

Postoperative complications according to the Clavien-Dindo classification

Opioid consumption during the first 24 hours postoperative

Both as a the need for opioids and the amount equivalent to intravenous morphine.

Need for rescue antiemetics during the first 24 hours postoperative

Duration of postoperative hospital stay

The duration of the postoperative hospital stay in hours.

Full Information

NCT ID

NCT02711449

First Posted

February 23, 2016

Last Updated

September 24, 2016

Sponsor

Jakob Kleif

Collaborators

Zealand University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02711449

Brief Title

Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Official Title

Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jakob Kleif

Collaborators

Zealand University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Suspected Appendicitis

Keywords

acute surgery, laparoscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methylprednisolone

Arm Type

Experimental

Arm Description

125 mg Methylprednisolone intravenously approximately 30 minutes prior to skin incision

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0.9% Saline intravenously approximately 30 minutes prior to skin incision

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Other Intervention Name(s)

Solu-Medrol

Intervention Description

125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision.

Intervention Type

Drug

Intervention Name(s)

0.9% Saline

Other Intervention Name(s)

Placebo

Intervention Description

0,9% Saline as an intravenously bolus injection approximately 30 minutes prior to skin incision.

Primary Outcome Measure Information:

Title

Pain at rest during the first 3 postoperative days on a 11-point NRS

Description

Powered to detect 30% reduction, Random regression model (mixed effects model)

Time Frame

6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3

Secondary Outcome Measure Information:

Title

Pain when coughing during the first 3 postoperative days on a 11-point NRS

Description

Random regression model (mixed effects model)

Time Frame

6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3

Title

Fatigue during the first 3 postoperative days on a 11-point NRS

Description

Random regression model (mixed effects model)

Time Frame

6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3

Title

Sleep during the first 3 postoperative days on a 11-point NRS

Time Frame

postoperative day (POD) 1, POD2 and POD3

Title

QoR-15 during the first 3 postoperative days

Description

Powered to detect 15% increase,

Time Frame

postoperative day (POD) 1, POD2 and POD3

Title

Incidence of postoperative nausea or vomiting during the first postoperative day

Time Frame

6 hours, 12 hours and 24-32 hours postoperative

Title

Pain at rest after POD3 on a 11-point NRS

Time Frame