Bupivacaine hydrochloride, anhydrous for Postoperative recovery after elective minimally invasive colorectal surgery

Inclusion criteria

• {"criterion_text":"- 18 years or older"}
• {"criterion_text":"- Scheduled for minimally invasive colorectal surgery"}
• {"criterion_text":"- Provided written informed consent"}

Exclusion criteria

• {"criterion_text":"- Any contra-indication to the CWI system or allergies for the used local analgesic"}
• {"criterion_text":"- Inflammatory Bowel Disease: ulcerative colitis or Crohn’s disease"}
• {"criterion_text":"- Emergency surgery"}
• {"criterion_text":"- Chronic opioid consumption (i.e. daily use for at least 90 days), or active drug addiction"}

Primary endpoints

• {"endpoint_text":"- Postoperative recovery will be measured and recorded using the Quality of Recovery (QoR) Questionnaire score, conducted daily from the first postoperative day until the fifth postoperative day (see addendum A). The questionnaire will be prompted and completed digitally using the electronic case report form (eCRF) of an ISO 27001 certified study database.","definition_or_measurement_approach":"Measured using the Quality of Recovery (QoR) Questionnaire administered daily from postoperative day 1 until day 5; questionnaire completed digitally via the eCRF of an ISO 27001 certified study database."}

Secondary endpoints

• {"endpoint_text":"- Postoperative pain levels will be measured and recorded using the Numeric Rating Scale (NRS), contained within the daily questionnaire (see addendum A). The questionnaire will be prompted and completed digitally using the electronic case report form (eCRF) of an ISO 27001 certified study database. Additionally, NRS score will be registered daily by nursing staff during postoperative hospital stay, as is standard in the participating centre.","definition_or_measurement_approach":"NRS scores collected within the daily digital questionnaire and also registered daily by nursing staff during postoperative hospital stay."}
• {"endpoint_text":"- Postoperative analgesic use will be recorded within the daily questionnaire (see addendum A). The questionnaire will be prompted and completed digitally using the electronic case report form (eCRF) of an ISO 27001 certified study database. Additionally, administration of any medication (including administration of opioids) will be registered by the treating physician, as is standard in the participating centre. Opioid consumption will be converted to milligrams (mg) of morphine equivalents.","definition_or_measurement_approach":"Analgesic use recorded in daily digital questionnaire and medication administrations registered by treating physician; opioid consumption converted to mg morphine equivalents."}
• {"endpoint_text":"- Date of discharge and functional recovery will be noted in the patient file by the treating physician.","definition_or_measurement_approach":"Date of discharge and functional recovery recorded in patient file by treating physician."}
• {"endpoint_text":"- Possible complications will be included from date of surgery up to 90 days after surgery and are registered in the patient file by the treating physician. Complications will be graded according to Clavien-Dindo. These data will be extracted from de EIAS database as well as the patient file.","definition_or_measurement_approach":"Complications recorded from surgery date up to 90 days, registered in patient file, graded according to Clavien-Dindo; data extracted from EIAS database and patient file."}
• {"endpoint_text":"- These markers of recovery will be noted by the nursing staff in the patient file, as is standard in the participating centre, and will additionally be included in the daily questionnaire.","definition_or_measurement_approach":"Recovery markers noted by nursing staff in patient file and collected in daily digital questionnaire."}
• {"endpoint_text":"- ERAS compliance data will be extracted from the EIAS database, where it is noted in percentage of adhered pre-, intra-, and post-operative guidelines.","definition_or_measurement_approach":"ERAS compliance extracted from EIAS database and reported as percentage adherence to pre-, intra-, and post-operative guidelines."}

Netherlands

Earliest CTIS Part Ii Submission Date

09-07-2024

Latest Decision Or Authorization Date

11-07-2024

Processing Time Days

2

Number Of Sites

1

Number Of Participants

192

Primary sponsor

Full Name

Catharina Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Medisch Specialistisch Bedrijf (MSB) Innovatiefonds","duties_or_roles":"Source of monetary support","organisation_type":""}