Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07431892
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 years or older
* Signed informed consent
* Meeting inclusion requirements of the hospital's Enhanced Recovery Protocol (RICA program), including:
* Adequate cognitive status
* ASA (American Society of Anesthesiologists) classification I, II, or III
* Elective colon surgery (right or left hemicolectomy) for malignant disease
* Planned laparoscopic or robotic surgical approach
* Preoperative evaluation completed as per RICA protocol (nutritional, nursing, anesthetic, and pharmacy assessments)
Exclusion Criteria:
* Patients with a preoperative decision for open surgery
* Patients undergoing rectal surgery (partial or total mesorectal excision without protective stoma)
* Patients with inflammatory bowel disease requiring colorectal resection
* Patients requiring multivisceral resection due to oncologic indications identified intraoperatively
* Extraction incision different from Pfannenstiel approach
* Current or past history of chronic opioid use or opioid abuse
* Current or past history of benzodiazepine use or abuse
* Chronic use of analgesics for other comorbid medical conditions
* Current or past history of recreational drug use or abuse
* Non-compliance with the RICA protocol, including:
* Lack of preoperative nutritional, nursing, anesthetic, or pharmacy evaluation
* Non-adherence to preoperative care protocols (e.g., premedication, fasting, carbohydrate loading, thromboembolism prophylaxis, antibiotic prophylaxis, anesthetic care guidelines)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07431892
Study Brief:
Protocol Section:
NCT07431892