Comparing postoperative pain after robotic versus laparoscopic colorectal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational comparison at Hospital General Universitario Gregorio Marañón in Madrid enrolling adults undergoing elective colon surgery performed with either laparoscopic or robotic-assisted techniques. Eligible patients meet the hospital's Enhanced Recovery After Surgery (RICA) protocol and are included based on planned surgical approach and clinical availability rather than random assignment. Postoperative pain will be measured with the Visual Analog Scale at arrival to recovery, on admission to the ward, at 24, 48 and 72 hours, and at discharge, while intraoperative nociception will be recorded using the Nociception Level Index (NOL). Secondary outcomes include postoperative opioid consumption, length of hospital stay, complication rates (Clavien-Dindo), readmissions, reinterventions, and patient-reported quality of life up to six months.

Why it matters

Who can join: the full rules

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)

Where it's running

• University Hospital Gregorio Marañon
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Patricia Tejedor Patricia Tejedor, M.D.,Ph.D. — University Hospital Gregorio Marañón
• Study coordinator: Patricia Tejedor Patricia Tejedor, M.D., Ph.D.
• Email: tejedorpat@gmail.com
• Phone: 0034915 86 80 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.