Does Omission of NSAIDs After Colorectal Cancer Operation Affect the Consumption of Opioids?

NCT04448652 | Completed

• 2 other identifiers: nsaid_syt18-000315/115
• Study Type: observational
• Target: 502
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing an operation for colorectal cancer are normally treated with non-steroid-anti-inflammatory-drugs (NSAIDs) e.g. ibuprofen as pain medication after the operation. It is well known that NSAIDs can be harmful to kidney-and heart patients and some studies also have shown an increased risc of surgical complications after treatment with NSAIDs. On the other hand recent studies have found a preventive effect of NSAIDs on colorectal cancer recurrence thus leaving the colorectal surgeon in doubt whether NSAIDs are beneficial or harmful to colorectal cancer patients. In the department of colorectal cancer surgery at Zealand University Hospital it was decided to leave out NSAIDs from the 1st of april 2016. This study will investigate if there is a change in consumption of opioids before and after omission of NSAIDs. This will be an important finding because opioids also have harmful side-effects as well as a risk of addiction. The investigators will also compare the blood samples and see if there is signs of impaired renal and cardiac function in the group that was treated with NSAIDs. Finally the long term outcomes will be investigated such as cancer recurrence and death in the two groups.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid-consumption

  potential changes in the total p.n. use of opioids measured in oral morphine equivalent doses in mg (omeq)

  from the day of operation and until discharge (median 3 days)

Secondary Outcomes (4)

• Postoperative renal impact

  from the day of operation and 7 days postoperatively or until discharge.

• Postoperative cardiac impact

  was measured on day 1 to 4 after surgery or intil discharge.

• Colorectal cancer recurrence

  120 days after surgery and until data collection.

• mortality

  From the day of operation and 3 to 5 years after (at the time of data collection).

Study Arms (2)

+NSAIDs

Patients undergoing elective colorectal cancer resection before april 1st 2016 were treated with paracetamol tablets 1000 mg and ibuprofen tablets 400 mg four times a day from the day of the operation and until discharge.

Drug: NSAID

-NSAIDs

Patients undergoing elective colorectal cancer resection from april 1st 2016 were only treated with paracetamol tablets 1000 mg four times a day from the day of the operation and until discharge.

Interventions

NSAID DRUG

no other intervention than described in the groups.

+NSAIDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective laparoscopic colorectal cancer resection at Zealand University Hospital, Denmark before and after 1st. of April 2016 are eligible for the study. Patients with a preoperative use of opioids within the last 3 months, undergoing a palliative resection or had a surgical complication leading to reoperation in general anesthesia will be excluded. Palliative resection is defined as patients with symptomatic metastatic colorectal cancer that undergoes resection of the primary tumor with the aim to relieve symptoms such as obstruction, bleeding or perforation.

You may qualify if:

• adults undergoing elective colorectal cancer resection before and after April 1st 2016 at Zealand University Hospital, Denmark.

You may not qualify if:

• palliative resection
• preoperative use of opioids within the last 3 months
• patients with a surgical complication requiring re-operation in general anesthesia.

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, DK-4600, Denmark

Location

Related Publications (10)

• Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006 Jun 3;332(7553):1302-8. doi: 10.1136/bmj.332.7553.1302.

  PMID: 16740558 BACKGROUND

• Coxib and traditional NSAID Trialists' (CNT) Collaboration; Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30.

  PMID: 23726390 BACKGROUND

• Ungprasert P, Cheungpasitporn W, Crowson CS, Matteson EL. Individual non-steroidal anti-inflammatory drugs and risk of acute kidney injury: A systematic review and meta-analysis of observational studies. Eur J Intern Med. 2015 May;26(4):285-91. doi: 10.1016/j.ejim.2015.03.008. Epub 2015 Apr 8.

  PMID: 25862494 BACKGROUND

• Klein M, Gogenur I, Rosenberg J. Postoperative use of non-steroidal anti-inflammatory drugs in patients with anastomotic leakage requiring reoperation after colorectal resection: cohort study based on prospective data. BMJ. 2012 Sep 26;345:e6166. doi: 10.1136/bmj.e6166.

  PMID: 23015299 BACKGROUND

• Bakker N, Deelder JD, Richir MC, Cakir H, Doodeman HJ, Schreurs WH, Houdijk AP. Risk of anastomotic leakage with nonsteroidal anti-inflammatory drugs within an enhanced recovery program. J Gastrointest Surg. 2016 Apr;20(4):776-82. doi: 10.1007/s11605-015-3010-1. Epub 2015 Nov 4.

  PMID: 26536884 BACKGROUND

• Dulai PS, Singh S, Marquez E, Khera R, Prokop LJ, Limburg PJ, Gupta S, Murad MH. Chemoprevention of colorectal cancer in individuals with previous colorectal neoplasia: systematic review and network meta-analysis. BMJ. 2016 Dec 5;355:i6188. doi: 10.1136/bmj.i6188.

  PMID: 27919915 BACKGROUND

• Bernardi MH, Schmidlin D, Schiferer A, Ristl R, Neugebauer T, Hiesmayr M, Druml W, Lassnigg A. Impact of preoperative serum creatinine on short- and long-term mortality after cardiac surgery: a cohort study. Br J Anaesth. 2015 Jan;114(1):53-62. doi: 10.1093/bja/aeu316. Epub 2014 Sep 19.

  PMID: 25240162 BACKGROUND

• Lassnigg A, Schmid ER, Hiesmayr M, Falk C, Druml W, Bauer P, Schmidlin D. Impact of minimal increases in serum creatinine on outcome in patients after cardiothoracic surgery: do we have to revise current definitions of acute renal failure? Crit Care Med. 2008 Apr;36(4):1129-37. doi: 10.1097/CCM.0b013e318169181a.

  PMID: 18379238 BACKGROUND

• Schack A, Fransgaard T, Klein MF, Gogenur I. Perioperative Use of Nonsteroidal Anti-inflammatory Drugs Decreases the Risk of Recurrence of Cancer After Colorectal Resection: A Cohort Study Based on Prospective Data. Ann Surg Oncol. 2019 Nov;26(12):3826-3837. doi: 10.1245/s10434-019-07600-8. Epub 2019 Jul 16.

  PMID: 31313040 BACKGROUND

• Devereaux PJ, Duceppe E, Guyatt G, Tandon V, Rodseth R, Biccard BM, Xavier D, Szczeklik W, Meyhoff CS, Vincent J, Franzosi MG, Srinathan SK, Erb J, Magloire P, Neary J, Rao M, Rahate PV, Chaudhry NK, Mayosi B, de Nadal M, Iglesias PP, Berwanger O, Villar JC, Botto F, Eikelboom JW, Sessler DI, Kearon C, Pettit S, Sharma M, Connolly SJ, Bangdiwala SI, Rao-Melacini P, Hoeft A, Yusuf S; MANAGE Investigators. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial. Lancet. 2018 Jun 9;391(10137):2325-2334. doi: 10.1016/S0140-6736(18)30832-8.

  PMID: 29900874 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Ismail Gögenur, Med.Sc.D

  Professor

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 26, 2020
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

DK (1)