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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550156
• Other study ID #: EvaCol
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1141
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged = 18 years

• Patients undergoing any left sided emergency or elective colorectal resections

• Patients should have given or will give a general consent

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Anastomotic Leak
• Colorectal Cancer
• Colorectal Disorders
• Complication of Surgical Procedure
• Surgery--Complications

Intervention

Procedure:
• Colorectal Bundle
Preoperative optimization of the nutritional status: Perform nutritional risk screening (NRS), measure albumin or prealbumin preoperatively and initiate nutritional support Preoperative showering with an antiseptic agent Administer preoperative antibiotic prophylaxis Hair removal in the operative field with clippers Peri-, intra-, and postoperative warming to maintain body temperature Peri- and intraoperative glucose control Usage of a wound protection device Change of gloves and instruments after anastomosis Anastomosis only with experienced senior surgeon present in theatre for any elective and emergency procedures

Locations

Country	Name	City	State
Switzerland	Lantonsspital Aarau	Aarau	Kanton Aargau
Switzerland	Clarunis-universitäres Bauchzentrum	Basel	Kanton Basel Stadt
Switzerland	Spitalzentrum Biel	Biel	Kanton Bern
Switzerland	Kantonsspital Baselland	Liestal	Kanton Basel-Land
Switzerland	Kantonsspital Luzern	Luzern	Kanton Luzern
Switzerland	Kantonsspital Olten	OLten	Kanton Solothurn
Switzerland	Spital Limmattal	Schlieren	Kanton Zürich

Sponsors (8)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clarunis - Universitäres Bauchzentrum Basel, Hospital Centre Biel/Bienne, Kantonsspital Aarau, Kantonsspital Liestal, Kantonsspital Olten, Luzerner Kantonsspital, Spital Limmattal Schlieren

Country where clinical trial is conducted

Switzerland, 

References & Publications (25)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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de Vries FE, Gans SL, Solomkin JS, Allegranzi B, Egger M, Dellinger EP, Boermeester MA. Meta-analysis of lower perioperative blood glucose target levels for reduction of surgical-site infection. Br J Surg. 2017 Jan;104(2):e95-e105. doi: 10.1002/bjs.10424. Epub 2016 Nov 30. — View Citation

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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. — View Citation

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Madrid E, Urrutia G, Roque i Figuls M, Pardo-Hernandez H, Campos JM, Paniagua P, Maestre L, Alonso-Coello P. Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults. Cochrane Database Syst Rev. 2016 Apr 21;4(4):CD009016. doi: 10.1002/14651858.CD009016.pub2. — View Citation

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. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) .	30 days
Secondary	Surgical side infections	Rate of surgical side infections within 30 days	30 days
Secondary	Number of patients who died within 30 days	Postoperative mortality within 30 days	30 days
Secondary	Hospital length of stay	Length of hospital stay in days	immediately after discharge
Secondary	Contribution margin	Measured as the difference between allocated costs and billed and payed income for a particular case	immediately after discharge
Secondary	Rate of anastomotic leakage	Any radiologically or clinically diagnosed anastomotic leakage	30 days