Continuous Wound Infiltration versus placebo following elective minimally invasive colorectal surgery; a double-blinded, randomised, placebo-controlled, low-intervention trial (CIMICS trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Catharina Ziekenhuis Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

30 Oct 2024 → ongoing

Decision date (initial)

2024-07-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Medisch Specialistisch Bedrijf (MSB) Innovatiefonds

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To determine the effect of continuous wound infusion with local analgesics on post-operative recovery for patients who underwent minimally invasive colorectal surgery

Secondary objectives 6

1. To compare postoperative pain levels between the interventional and control arm.
2. To compare postoperative opioid use between the interventional and control arm.
3. To compare postoperative length of stay and time until functional recovery between the interventional and control arm.
4. To compare incidence of postoperative complications between the interventional and control arm.
5. To compare parameters related to postoperative recovery, such as time until first flatulence and stool passage, mobilisation, intake, intravenous fluid administration, and condition at discharge between the interventional and control arm.
6. To compare compliance to the ERAS protocol between the interventional and control arm.

Conditions and MedDRA coding

Recovery following elective minimally invasive colorectal surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 18 years or older
2. Scheduled for minimally invasive colorectal surgery
3. Provided written informed consent

Exclusion criteria 4

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 6

1. 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.
2. 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.
3. Date of discharge and functional recovery will be noted in the patient file by the treating physician.
4. 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.
5. 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.
6. ERAS compliance data will be extracted from the EIAS database, where it is noted in percentage of adhered pre-, intra-, and post-operative guidelines.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Catharina Ziekenhuis Stichting

Sponsor organisation

Catharina Ziekenhuis Stichting

Address

Michelangelolaan 2

City

Eindhoven

Postcode

5623 EJ

Country

Netherlands

Scientific contact point

Organisation

Catharina Ziekenhuis Stichting

Contact name

Johanne Bloemen

Public contact point

Organisation

Catharina Ziekenhuis Stichting

Contact name

Johanne Bloemen

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications