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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04550156

Studienbeginn:
Oktober 2020

Letztes Update:
04.11.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Anastomotic Leak

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Basel, Switzerland

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

Studienleiter

Marco von Strauss und Tourney, PD Dr.
Principal Investigator
Clarunis - Universitäres Bauchzentrum Basel
Markus Zuber, Prof. Dr.
Study Director
Clarunis - Universitäres Bauchzentrum Basel

Kontakt

Marco von Strauss und Tourney, PD Dr.
Kontakt:
Phone: +41 61 777 73 21
E-Mail: marco.vonstrauss@clarunis.ch
» Kontaktdaten anzeigen

Studienlocations (3 von 7)

Clarunis-universitäres Bauchzentrum
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Marco von Strauss und Torney, PD Dr.
Phone: +41 61 777 73 21
E-Mail: marco.vonstrauss@clarunis.ch

Markus Zuber, Prof. Dr.
Phone: +41 61 777 73 28
E-Mail: markus.zuber@clarunis.ch
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Comprehensive complication index (Time Frame - 30 days):
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) .



Secondary outcome:

1. Surgical side infections (Time Frame - 30 days):
Rate of surgical side infections within 30 days

2. Number of patients who died within 30 days (Time Frame - 30 days):
Postoperative mortality within 30 days

3. Hospital length of stay (Time Frame - immediately after discharge):
Length of hospital stay in days

4. Contribution margin (Time Frame - immediately after discharge):
Measured as the difference between allocated costs and billed and payed income for a particular case

5. Rate of anastomotic leakage (Time Frame - 30 days):
Any radiologically or clinically diagnosed anastomotic leakage

Studien-Arme

  • No Intervention: Control Arm
    Patients are treated according to current local standards
  • Experimental: Colorectal Bundle Arm
    Patients are treated according to the colorectal bundle

Geprüfte Regime

  • 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

Quelle: ClinicalTrials.gov


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