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Colorectal DisordersNCT04550156

Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections

A study testing Colorectal Bundle in people with Colorectal Disorders and Surgery--Complications, run by University Hospital, Basel, Switzerland at 7 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The complication rate in colorectal surgery is high and shows a large variance depending on the patient and the treating surgeon. The primary aim of the presented study is to evaluate the introduction of a colorectal bundle to reduce the complication rate in left sided colorectal resections. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Colorectal Bundle
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,141 participants
Where
7 sitesSwitzerland
Study dates
1 Oct 2020to 31 Dec 2022
Phase
Interventional
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

  • aged ≥ 18 years
  • Patients undergoing any left sided emergency or elective colorectal resections
  • Patients should have given or will give a general consent

Who cannot join

  • no general consent given
  • unable to provide informed general consent
  • vulnerable patients (Age < 18 years or patients with severe dementia)
  • the intervention is a reoperation within 30 days of primary operation
  • Exclusion criteria for an antibiotic decontamination subgroup:
  • known allergy to one of the applied antibiotic regimes
Show all 12Show fewer
  • active bacterial infection requiring systemic antibiotics
  • IV or oral antibiotics in past 7 days prior to the planned decontamination
  • terminal kidney disease
  • unable to take antibiotic decontamination medication
  • pregnancy or breastfeeding
  • emergency or expedited surgery

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Switzerland7 sites

  • Lantonsspital Aarau

    Aarau, Canton of Aargau, 5001

  • Clarunis-universitäres Bauchzentrum

    Basel, Canton of Basel-City, 4031

  • Spitalzentrum Biel

    Biel/Bienne, Canton of Bern, 2501

  • Kantonsspital Baselland

    Liestal, Basel-Landschaft, 4410

  • Kantonsspital Luzern

    Lucerne, Canton of Lucerne, 6004

  • Kantonsspital Olten

    Olten, Canton of Solothurn, 4600

  • Spital Limmattal

    Schlieren, Canton of Zurich, 8652

Other trials in Switzerland

About this study

The complication rate in colorectal surgery is high and shows a large variance depending on the patient and the treating surgeon. The primary aim of the presented study is to evaluate the introduction of a colorectal bundle to reduce the complication rate in left sided colorectal resections. The colorectal bundle is a catalog of measures consisting of several items These are for example preoperative risk stratification, antibiotic and mechanical bowel preparation and preoperative showering. The primary endpoint will be the complication rate measured as the comprehensive clinical index (CCI) within 30 days. Investigators will include patients that undergo elective or emergency left sided colorectal surgery.

Being tested
Colorectal Bundle
Medical subject headings
Colorectal Neoplasms, Anastomotic Leak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colorectal BundleProcedure or surgery

    1. Preoperative optimization of the nutritional status: Perform nutritional risk screening (NRS), measure albumin or prealbumin preoperatively and initiate nutritional support
    2. Preoperative showering with an antiseptic agent
    3. Administer preoperative antibiotic prophylaxis
    4. Hair removal in the operative field with clippers
    5. Peri-, intra-, and postoperative warming to maintain body temperature
    6. Peri- and intraoperative glucose control
    7. Usage of a wound protection device
    8. Change of gloves and instruments after anastomosis
    9. Anastomosis only with experienced senior surgeon present in theatre for any elective and emergency procedures
Study groups in NCT04550156
Study groupRoleWhat they receive
Control ArmNo interventionPatients are treated according to current local standards
Colorectal Bundle ArmExperimentalPatients are treated according to the colorectal bundle
Receives: Procedure: Colorectal Bundle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comprehensive complication index

    The primary endpoint is the comprehensive complication index (CCI) at 30 days after the index procedure, a continuous scale to measure surgical morbidity that has been developed on the basis of the Clavien Dindo Classification for surgical complications and summarizes and weighs all postoperative complications to a scale from 0 (no complications) to 100 (death of the patient) .

    Measured: 30 days

Secondary outcomes (5)

  1. Surgical side infections

    Rate of surgical side infections within 30 days

    Measured: 30 days

  2. Number of patients who died within 30 days

    Postoperative mortality within 30 days

    Measured: 30 days

  3. Hospital length of stay

    Length of hospital stay in days

    Measured: immediately after discharge

  4. Contribution margin

    Measured as the difference between allocated costs and billed and payed income for a particular case

    Measured: immediately after discharge

  5. Rate of anastomotic leakage

    Any radiologically or clinically diagnosed anastomotic leakage

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start1 Oct 2020
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomised, multicenter trial
Masking
None (open label)
Enrolment
1,141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04550156
Sponsor's protocol ID
EvaCol
Status last verified
Mar 2024
First submitted
19 Aug 2020
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bergvall M, Skullman S, Kodeda K, Larsson PA. Better survival for patients with colon cancer operated on by specialized colorectal surgeons - a nationwide population-based study in Sweden 2007-2010. Colorectal Dis. 2019 Dec;21(12):1379-1386. doi: 10.1111/codi.14760. Epub 2019 Jul 30.

    PubMed 31293019

  • 2017 European Society of Coloproctology (ESCP) collaborating group. Safety of primary anastomosis following emergency left sided colorectal resection: an international, multi-centre prospective audit. Colorectal Dis. 2018 Sep;20 Suppl 6:47-57. doi: 10.1111/codi.14373.

    PubMed 30255647

  • 2017 European Society of Coloproctology (ESCP) Collaborating Group. The 2017 European Society of Coloproctology (ESCP) international snapshot audit of left colon, sigmoid and rectal resections - Executive Summary. Colorectal Dis. 2018 Sep;20 Suppl 6:13-14. doi: 10.1111/codi.14391. No abstract available.

    PubMed 30255645

  • Borstlap WAA, Westerduin E, Aukema TS, Bemelman WA, Tanis PJ; Dutch Snapshot Research Group. Anastomotic Leakage and Chronic Presacral Sinus Formation After Low Anterior Resection: Results From a Large Cross-sectional Study. Ann Surg. 2017 Nov;266(5):870-877. doi: 10.1097/SLA.0000000000002429.

    PubMed 28746154

  • Frasson M, Flor-Lorente B, Rodriguez JL, Granero-Castro P, Hervas D, Alvarez Rico MA, Brao MJ, Sanchez Gonzalez JM, Garcia-Granero E; ANACO Study Group. Risk Factors for Anastomotic Leak After Colon Resection for Cancer: Multivariate Analysis and Nomogram From a Multicentric, Prospective, National Study With 3193 Patients. Ann Surg. 2015 Aug;262(2):321-30. doi: 10.1097/SLA.0000000000000973.

    PubMed 25361221

  • Amri R, Dinaux AM, Kunitake H, Bordeianou LG, Berger DL. Risk Stratification for Surgical Site Infections in Colon Cancer. JAMA Surg. 2017 Jul 1;152(7):686-690. doi: 10.1001/jamasurg.2017.0505.

    PubMed 28403477

  • Bisig B, Gutzwiller F, Domenighetti G. [Incidence of operations in Switzerland related to insurance status]. Swiss Surg. 1998;4(3):109-16; discussion 116-7. German.

    PubMed 9655004

  • Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.

    PubMed 19144931

  • Haugen AS, Softeland E, Almeland SK, Sevdalis N, Vonen B, Eide GE, Nortvedt MW, Harthug S. Effect of the World Health Organization checklist on patient outcomes: a stepped wedge cluster randomized controlled trial. Ann Surg. 2015 May;261(5):821-8. doi: 10.1097/SLA.0000000000000716.

    PubMed 24824415

  • Tanner J, Padley W, Assadian O, Leaper D, Kiernan M, Edmiston C. Do surgical care bundles reduce the risk of surgical site infections in patients undergoing colorectal surgery? A systematic review and cohort meta-analysis of 8,515 patients. Surgery. 2015 Jul;158(1):66-77. doi: 10.1016/j.surg.2015.03.009. Epub 2015 Apr 25.

    PubMed 25920911

  • Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.

    PubMed 28467526

  • Fry DE. Review of The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Use of Bowel Preparation in Elective Colon and Rectal Surgery. JAMA Surg. 2020 Jan 1;155(1):80-81. doi: 10.1001/jamasurg.2019.4551. No abstract available.

    PubMed 31693066

  • McDermott FD, Heeney A, Kelly ME, Steele RJ, Carlson GL, Winter DC. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal anastomotic leaks. Br J Surg. 2015 Apr;102(5):462-79. doi: 10.1002/bjs.9697. Epub 2015 Feb 19.

    PubMed 25703524

  • Allegranzi B, Zayed B, Bischoff P, Kubilay NZ, de Jonge S, de Vries F, Gomes SM, Gans S, Wallert ED, Wu X, Abbas M, Boermeester MA, Dellinger EP, Egger M, Gastmeier P, Guirao X, Ren J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e288-e303. doi: 10.1016/S1473-3099(16)30402-9. Epub 2016 Nov 2.

    PubMed 27816414

  • Bertschi D, Weber WP, Zeindler J, Stekhoven D, Mechera R, Salm L, Kralijevic M, Soysal SD, von Strauss M, Mujagic E, Marti WR. Antimicrobial Prophylaxis Redosing Reduces Surgical Site Infection Risk in Prolonged Duration Surgery Irrespective of Its Timing. World J Surg. 2019 Oct;43(10):2420-2425. doi: 10.1007/s00268-019-05075-y.

    PubMed 31292675

Questions about this trial

What is this clinical trial studying?

A study testing Colorectal Bundle in people with Colorectal Disorders and Surgery--Complications, run by University Hospital, Basel, Switzerland at 7 sites in Switzerland.

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 3 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Comprehensive complication index (time frame: 30 days). 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 NCT04550156, which also lists 28 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 12 Mar 2024.

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