The Change in RetHe - Levels Perioperatively in a Cohort of Colorectal Surgery Patient

NCT03500497 | Completed

• 1 other identifier: RACEmumc
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

During a period of a year, reticulocyte hemoglobin content (RetHe) measurements (Sysmex) are done out of blood samples taken on several occasions during normal patient care:

1. 1.preoperatively at the surgical or anesthetic outpatient visit
2. 2.on admission or pre- induction of anesthesia
3. 3.postoperatively at the postanesthetic care unit
4. 4.on day 3 postoperatively
5. 5.on day 5 postoperatively

Conditions

Anemia; Colorectal Surgery; Perioperative

Keywords

reticulocyte hemoglobin content (RetHe); perioperative; colorectal surgery; anemia

Outcome Measures

Primary Outcomes (1)

• Change of RetHe measurement

  To assess the change of RetHe measurement from baseline (preoperative assessment) to different points in time in standard care (i.e. RetHe measurement at day of admission, direct postoperatively and day 3 and 5 postoperatively)

  From baseline to 60 days postoperatively

Secondary Outcomes (3)

• Relation of RetHe to standard iron status measurements

  1 year

• Perioperative complications

  Days of admission

• Quality of life measurement preoperatively and 30-days postoperatively

  From baseline to 30-days postoperatively

Interventions

RetHe measurement (Sysmex) DIAGNOSTIC_TEST

RetHe measurement is done from blood samples gained during standard patient care perioperatively

Eligibility Criteria

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

Study Population

elective colorectal surgery patients (cancer surgery, inflammatory disease, other pathologies needing elective intestinal surgery)

You may qualify if:

• All adult patients (≥ 18 years) scheduled for colorectal surgical operations (laparoscopic and open procedures)

You may not qualify if:

• emergency surgery
• minors and incapacitated

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MUMC

Maastricht, Limburg, Netherlands

Location

Related Publications (16)

• Aapro M, Osterborg A, Gascon P, Ludwig H, Beguin Y. Prevalence and management of cancer-related anaemia, iron deficiency and the specific role of i.v. iron. Ann Oncol. 2012 Aug;23(8):1954-1962. doi: 10.1093/annonc/mds112. Epub 2012 May 9.

  PMID: 22575608 BACKGROUND

• Archer NM, Brugnara C. Diagnosis of iron-deficient states. Crit Rev Clin Lab Sci. 2015;52(5):256-72. doi: 10.3109/10408363.2015.1038744. Epub 2015 Aug 14.

  PMID: 26292073 BACKGROUND

• Clevenger B, Richards T. Pre-operative anaemia. Anaesthesia. 2015 Jan;70 Suppl 1:20-8, e6-8. doi: 10.1111/anae.12918.

  PMID: 25440391 BACKGROUND

• Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery: A Randomized Controlled Trial. Ann Surg. 2016 Jul;264(1):41-6. doi: 10.1097/SLA.0000000000001646.

  PMID: 26817624 BACKGROUND

• Gozzard D. When is high-dose intravenous iron repletion needed? Assessing new treatment options. Drug Des Devel Ther. 2011 Jan 20;5:51-60. doi: 10.2147/DDDT.S15817.

  PMID: 21340038 BACKGROUND

• Herrera-deGuise C, Casellas F, Robles V, Navarro E, Borruel N. Iron Deficiency in the Absence of Anemia Impairs the Perception of Health-Related Quality of Life of Patients with Inflammatory Bowel Disease. Inflamm Bowel Dis. 2016 Jun;22(6):1450-5. doi: 10.1097/MIB.0000000000000768.

  PMID: 27057682 BACKGROUND

• Jans O, Bandholm T, Kurbegovic S, Solgaard S, Kjaersgaard-Andersen P, Johansson PI, Kehlet H; Lundbeck Foundation Centre for Fast-Track Hip and Knee Replacement Collaborative Group. Postoperative anemia and early functional outcomes after fast-track hip arthroplasty: a prospective cohort study. Transfusion. 2016 Apr;56(4):917-25. doi: 10.1111/trf.13508. Epub 2016 Mar 4.

  PMID: 26945552 BACKGROUND

• Kanuri G, Sawhney R, Varghese J, Britto M, Shet A. Iron Deficiency Anemia Coexists with Cancer Related Anemia and Adversely Impacts Quality of Life. PLoS One. 2016 Sep 28;11(9):e0163817. doi: 10.1371/journal.pone.0163817. eCollection 2016.

  PMID: 27682226 BACKGROUND

• Keeler BD, Mishra A, Stavrou CL, Beeby S, Simpson JA, Acheson AG. A cohort investigation of anaemia, treatment and the use of allogeneic blood transfusion in colorectal cancer surgery. Ann Med Surg (Lond). 2015 Dec 22;6:6-11. doi: 10.1016/j.amsu.2015.12.052. eCollection 2016 Mar.

  PMID: 26909150 BACKGROUND

• Beale AL, Penney MD, Allison MC. The prevalence of iron deficiency among patients presenting with colorectal cancer. Colorectal Dis. 2005 Jul;7(4):398-402. doi: 10.1111/j.1463-1318.2005.00789.x.

  PMID: 15932566 BACKGROUND

• Mast AE, Blinder MA, Dietzen DJ. Reticulocyte hemoglobin content. Am J Hematol. 2008 Apr;83(4):307-10. doi: 10.1002/ajh.21090.

  PMID: 18027835 BACKGROUND

• Mouysset JL, Freier B, van den Bosch J, Levache CB, Bols A, Tessen HW, Belton L, Bohac GC, Terwey JH, Tonini G. Hemoglobin levels and quality of life in patients with symptomatic chemotherapy-induced anemia: the eAQUA study. Cancer Manag Res. 2016 Jan 21;8:1-10. doi: 10.2147/CMAR.S88110. eCollection 2016.

  PMID: 26855598 BACKGROUND

• Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5.

  PMID: 21982521 BACKGROUND

• So-Osman C, Nelissen R, Brand R, Brand A, Stiggelbout AM. Postoperative anemia after joint replacement surgery is not related to quality of life during the first two weeks postoperatively. Transfusion. 2011 Jan;51(1):71-81. doi: 10.1111/j.1537-2995.2010.02784.x.

  PMID: 20663113 BACKGROUND

• Thomas DW, Hinchliffe RF, Briggs C, Macdougall IC, Littlewood T, Cavill I; British Committee for Standards in Haematology. Guideline for the laboratory diagnosis of functional iron deficiency. Br J Haematol. 2013 Jun;161(5):639-648. doi: 10.1111/bjh.12311. Epub 2013 Apr 10. No abstract available.

  PMID: 23573815 BACKGROUND

• Urrechaga E, Borque L, Escanero JF. Biomarkers of hypochromia: the contemporary assessment of iron status and erythropoiesis. Biomed Res Int. 2013;2013:603786. doi: 10.1155/2013/603786. Epub 2013 Feb 28.

  PMID: 23555091 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Cornelia S Mueller, Dr

  MUMC Maastricht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: April 18, 2018
• Study Start: August 25, 2017
• Primary Completion: November 7, 2018
• Study Completion: January 2, 2019
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)