Comparing postoperative pain after robotic versus laparoscopic colorectal surgery
Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures
We will test whether robotic surgery causes less pain than laparoscopic surgery for adults having elective colon (right or left hemicolectomy) operations who meet the hospital's enhanced recovery (RICA) protocol.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Central de la Defensa Gómez Ulla Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT07431892 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for elective right or left hemicolectomy who can give informed consent and meet the hospital's RICA enhanced recovery and ASA I–III criteria are the ideal candidates.
Not a fit: Patients scheduled for open surgery, rectal procedures, multivisceral resections, those with inflammatory bowel disease, or patients with current or past chronic opioid use are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the results could help surgeons choose the approach that reduces postoperative pain and opioid use for elective colon surgery.
How similar studies have performed: Minimally invasive approaches in colorectal surgery have consistently shown less pain than open surgery, but direct comparisons between robotic and laparoscopic approaches for postoperative pain are limited and have produced mixed results.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Madrid
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.