Suspected AppendicitisPhase 2NCT02711449
Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy
A Phase 2 study testing Methylprednisolone and 0.9% Saline in people with Suspected Appendicitis, run by Jakob Kleif at 2 sites in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected Appendicitis
- What is being tested?
- Methylprednisolone and 0.9% Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 2 sitesDenmark
- Study dates
- Apr 2016to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopy for suspected appendicitis
- Age 18 years or older
- American Society of Anesthesiologist (ASA) class I-III.
- Gives written and oral consent
Who cannot join
- 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.
Show all 12Show fewer
- Known renal disease, GFR<30.
- Known liver cirrhosis.
- Known heart failure, EF<40%.
- Known glaucoma.
- Known ocular herpes simplex.
- Known cushings disease.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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).
- Conditions
- Suspected Appendicitis
- Being tested
- Methylprednisolone, 0.9% Saline
- Keywords
- acute surgery, laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Solu-Medrol
125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision.
0.9% SalineDrug
Also called Placebo
0,9% Saline as an intravenously bolus injection approximately 30 minutes prior to skin incision.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | 125 mg Methylprednisolone intravenously approximately 30 minutes prior to skin incision Receives: Drug: Methylprednisolone |
| Placebo | Placebo comparator | 0.9% Saline intravenously approximately 30 minutes prior to skin incision Receives: Drug: 0.9% Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Secondary outcomes (19)
Pain when coughing during the first 3 postoperative days on a 11-point NRS
Random regression model (mixed effects model)
Measured: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Fatigue during the first 3 postoperative days on a 11-point NRS
Random regression model (mixed effects model)
Measured: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Sleep during the first 3 postoperative days on a 11-point NRS
Measured: postoperative day (POD) 1, POD2 and POD3
QoR-15 during the first 3 postoperative days
Powered to detect 15% increase,
Measured: postoperative day (POD) 1, POD2 and POD3
Incidence of postoperative nausea or vomiting during the first postoperative day
Measured: 6 hours, 12 hours and 24-32 hours postoperative
Pain at rest after POD3 on a 11-point NRS
Measured: postoperative day (POD) 7, POD 14 and POD 30
Pain when coughing after POD3 on a 11-point NRS
Measured: postoperative day (POD) 7, POD 14 and POD 30
Fatigue after POD3 on a 11-point NRS
Measured: postoperative day (POD) 7, POD 14 and POD 30
Sleep after POD3 on a 11-point NRS
Measured: postoperative day (POD) 7, POD 14 and POD 30
QoR-15 after POD 3
Measured: postoperative day (POD) 7, POD 14 and POD 30
Mobilization during the first postoperative day on a 4-point likert scale
Measured: 6 hours, 12 hours and postoperative day 1
Resumption of occupational activity
Number of days from surgery until resumption of occupational activities
Measured: Up to 60 days postoperative
Resumption of recreational activity
Number of days from surgery until resumption of recreational activities
Measured: Up to 60 days postoperative
Duration of convalescence
Number of days from surgery until resumption of both occupational and recreational activities
Measured: Up to 60 days postoperative
Adverse events according to GCP guidelines
Measured: 30 day postoperative
Postoperative complications according to the Clavien-Dindo classification
Measured: 30 day postoperative
Opioid consumption during the first 24 hours postoperative
Both as a the need for opioids and the amount equivalent to intravenous morphine.
Measured: 24 hours postoperative
Need for rescue antiemetics during the first 24 hours postoperative
Measured: 24 hours postoperative
Duration of postoperative hospital stay
The duration of the postoperative hospital stay in hours.
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suspected AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jakob Kleif
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital
- Responsible party
- Sponsor-investigator, Jakob Kleif, Nordsjaellands Hospital
- Investigators
- Jakob Kleif, M.D., Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711449
- Sponsor's protocol ID
- 2015-810
- Other IDs
- 2015-004800-46, 2015
- Status last verified
- Sep 2016
- First submitted
- 23 Feb 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21.
PubMed 29605019Kleif J, Hauge CI, Vilandt J, Gogenur I. Randomized Clinical Trial of Preoperative High-Dose Methylprednisolone on Postoperative Pain at Rest After Laparoscopic Appendectomy. Anesth Analg. 2018 May;126(5):1712-1720. doi: 10.1213/ANE.0000000000002693.
PubMed 29200067
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy
- ClinicalTrials.gov ID
- NCT02711449
- Acronym / sponsor ID
- 2015-810
- Conditions
- Suspected Appendicitis
- Keywords
- acute surgery, laparoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Jakob KleifUniversity, hospital or other
- Collaborators
- Zealand University Hospital
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: Methylprednisolone125 mg Methylprednisolone intravenously approximately 30 minutes prior to skin incision |
| Placebo | Placebo comparator | Drug: 0.9% Saline0.9% Saline intravenously approximately 30 minutes prior to skin incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Laparoscopy for suspected appendicitis
- Age 18 years or older
- American Society of Anesthesiologist (ASA) class I-III.
- Gives written and oral consent
Key exclusion criteria (12 listed)
- Known inflammatory bowel disease.
- Known autoimmune disease.
- Chronic pain patient.
- Presumed poor compliance.
- Pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneAlso: Solu-Medrol125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision. | Drug | Methylprednisolone |
| 0.9% SalineAlso: Placebo0,9% Saline as an intravenously bolus injection approximately 30 minutes prior to skin incision. | Drug | Placebo |
Primary outcome
Pain at rest during the first 3 postoperative days on a 11-point NRS
Time frame: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Powered to detect 30% reduction, Random regression model (mixed effects model)
19 secondary outcomes
Pain when coughing during the first 3 postoperative days on a 11-point NRS
Time frame: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Fatigue during the first 3 postoperative days on a 11-point NRS
Time frame: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3
Sleep during the first 3 postoperative days on a 11-point NRS
Time frame: postoperative day (POD) 1, POD2 and POD3
QoR-15 during the first 3 postoperative days
Time frame: postoperative day (POD) 1, POD2 and POD3
Incidence of postoperative nausea or vomiting during the first postoperative day
Time frame: 6 hours, 12 hours and 24-32 hours postoperative
Pain at rest after POD3 on a 11-point NRS
Time frame: postoperative day (POD) 7, POD 14 and POD 30
Pain when coughing after POD3 on a 11-point NRS
Time frame: postoperative day (POD) 7, POD 14 and POD 30
Fatigue after POD3 on a 11-point NRS
Time frame: postoperative day (POD) 7, POD 14 and POD 30
Sleep after POD3 on a 11-point NRS
Time frame: postoperative day (POD) 7, POD 14 and POD 30
QoR-15 after POD 3
Time frame: postoperative day (POD) 7, POD 14 and POD 30
Mobilization during the first postoperative day on a 4-point likert scale
Time frame: 6 hours, 12 hours and postoperative day 1
Resumption of occupational activity
Time frame: Up to 60 days postoperative
Resumption of recreational activity
Time frame: Up to 60 days postoperative
Duration of convalescence
Time frame: Up to 60 days postoperative
Adverse events according to GCP guidelines
Time frame: 30 day postoperative
Postoperative complications according to the Clavien-Dindo classification
Time frame: 30 day postoperative
Opioid consumption during the first 24 hours postoperative
Time frame: 24 hours postoperative
Need for rescue antiemetics during the first 24 hours postoperative
Time frame: 24 hours postoperative
Duration of postoperative hospital stay
Time frame: 30 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Derived from this study: PubMed 29605019Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21.
- Derived from this study: PubMed 29200067Kleif J, Hauge CI, Vilandt J, Gogenur I. Randomized Clinical Trial of Preoperative High-Dose Methylprednisolone on Postoperative Pain at Rest After Laparoscopic Appendectomy. Anesth Analg. 2018 May;126(5):1712-1720. doi: 10.1213/ANE.0000000000002693.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob Kleif, M.D. principal investigator
Nordsjaellands Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylprednisolone and 0.9% Saline in people with Suspected Appendicitis, run by Jakob Kleif at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at rest during the first 3 postoperative days on a 11-point NRS (time frame: 6 hours, 12 hours, postoperative day (POD) 1, POD2 and POD3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711449, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.