An observational study in Minimally Invasive Surgical Procedures and Colon Cancer Patients, sponsored by Hospital Central de la Defensa Gómez Ulla. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Hospital Central de la Defensa Gómez Ulla · Observational
Minimally invasive surgery for colorectal conditions, such as laparoscopic or robotic surgery, has been shown to offer benefits over traditional open surgery. These benefits include less pain after surgery, shorter hospital stays, and fewer complications.
This study aims to compare two types of minimally invasive surgery-laparoscopic and robotic surgery-to determine which approach results in less postoperative pain for patients undergoing colon or rectal surgery. The central hypothesis is that robotic surgery, due to its higher precision and reduced tissue trauma, will lead to lower pain levels after surgery.
The study will enroll adult patients scheduled for elective colorectal surgery at the Hospital General Universitario Gregorio Marañón in Madrid. Participants will undergo either laparoscopic or robotic surgery based on clinical availability and surgical planning, as long as they meet all inclusion criteria under the hospital's enhanced recovery protocol (RICA program).
Researchers will assess patients' pain levels at different time points after surgery (immediately after recovery, at 24, 48, and 72 hours, and at discharge) using validated pain scales. The use of pain medications, hospital stay duration, complication rates, and quality of life up to 12 months after surgery will also be measured.
All patient data will be collected anonymously using a secure electronic system (REDCap). The study will last approximately 2 years and include about 80 patients (40 in each group).
The results could help surgeons and hospitals choose the most effective surgical approach to reduce postoperative pain and improve patient recovery in colorectal surgery.
This is a prospective, single-center, observational study conducted at the Hospital General Universitario Gregorio Marañón in Madrid, Spain. The study compares postoperative pain outcomes in patients undergoing elective colorectal surgery via two different minimally invasive surgical approaches: laparoscopic and robotic-assisted surgery.
Eligible participants will be adults (≥18 years) undergoing elective colon or rectal surgery for benign or malignant disease, provided they meet the criteria of the hospital's Enhanced Recovery After Surgery (ERAS) program, known locally as the RICA protocol. Patients with open surgery indications, chronic analgesic use, or other exclusion criteria (e.g., inflammatory bowel disease, multivisceral resections, chronic opioid use, or inability to follow the RICA protocol) will not be included.
Pain will be assessed using the Visual Analog Scale (VAS) at standardized time points: on arrival at the post-anesthesia care unit, upon admission to the surgical ward, and at 24, 48, and 72 hours postoperatively, as well as at discharge. Intraoperative nociception will also be evaluated using the Nociception Level Index (NOL), an objective measure that reflects the patient's pain response during surgery.
Additional outcomes include postoperative opioid consumption, length of hospital stay, complication rates (using the Clavien-Dindo classification), hospital readmissions, reintervention rates, and patient-reported quality of life measures at 1, 3, 6, and 12 months after surgery, using validated questionnaires (QLQ-C30, QLQ-CR29, and EQ-5D).
Data will be collected and stored securely using the REDCap electronic data capture system, ensuring patient confidentiality. The estimated sample size is 80 patients (approximately 40 in each group), and the total study duration is expected to be 2 years for recruitment and follow-up, with an additional period for data analysis and publication.
The goal is to generate high-quality evidence to help guide clinical decision-making in the selection of surgical approaches for colorectal surgery, focusing on reducing postoperative pain and enhancing recovery.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 80 is below the median of 102 across 608 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Hospital Central de la Defensa Gómez Ulla is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥18 years) undergoing elective colorectal surgery (right or left colon resection) for malignant disease at the Hospital General Universitario Gregorio Marañón (Madrid, Spain), following the hospital's Enhanced Recovery After Surgery (ERAS) protocol (RICA program). All participants must meet strict inclusion criteria, including cognitive capacity and ASA I-III classification, and must consent to participate. Patients will receive either laparoscopic or robotic surgical approach based on surgical planning and equipment availability. The study will exclude individuals with prior chronic opioid use, certain comorbidities, or those requiring open surgery or multivisceral resection.
Exclusion Criteria:
Laparoscopic procedure
Robotic Procedure
Postoperative Pain
Assessment of patient-reported postoperative pain at 24 hours after surgery, using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 24 hours
Postoperative Pain at 48 Hours Measured by Visual Analog Scale (VAS)
Assessment of patient-reported postoperative pain at 48 hours after surgery, using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 48 hours post-surgery
Postoperative Pain at 72 Hours Measured by Visual Analog Scale (VAS)
Assessment of patient-reported postoperative pain at 72 hours after surgery, using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 72 hours post-surgery
Intraoperative Analgesic Consumption
Total intraoperative consumption of opioids (fentanyl and remifentanil), recorded in micrograms, as an indirect measure of nociception and analgesic requirements during surgery.
Time frame: Intraoperative period
Postoperative Analgesic Consumption
Total amount and type of analgesic medication administered during the postoperative hospital stay, including both scheduled and rescue analgesia.
Time frame: From recovery room admission up to 72 hours after surgery.
Postoperative Morbidity (Clavien-Dindo Classification)
Incidence and severity of postoperative complications up to 30 days after surgery, categorized according to the Clavien-Dindo classification system. Patients without complications will be recorded as Grade 0. Complications will be graded from Grade I (minor deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, or radiological interventions) to Grade V (death of the patient). The minimum possible value is 0 and the maximum possible value is V. Higher grades reflect greater severity of complications and therefore worse clinical outcomes.
Time frame: Within 30 days after surgery
Conversion Rate to Open Surgery
Number and percentage of patients requiring conversion from laparoscopic or robotic approach to open surgery during the procedure.
Time frame: Intraoperative period
Postoperative Inflammatory Response
Measurement of postoperative systemic inflammatory markers including C-reactive protein (CRP), at predefined postoperative time points (e.g., 24h and 48h).
Time frame: Within the first 48 hours post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30
Time frame: 1 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30
Time frame: 3 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30
Time frame: 6 month post-surgery
Postoperative Inflammatory Response
Measurement of postoperative systemic inflammatory markers including procalcitonin at predefined postoperative time points (e.g., 24h and 48h).
Time frame: Within the first 48 hours post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29
Time frame: 1 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29
Time frame: 3 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29
Time frame: 6 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EQ5D
Time frame: 1 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EQ5D
Time frame: 3 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EQ5D
Time frame: 6 month post-surgery
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data (IPD) will not be shared due to patient confidentiality concerns and institutional data protection policies. Additionally, the study is single-center with a limited sample size, and there is no formal data-sharing infrastructure or repository in place for this project.
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