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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Surgery | Laparoscopic procedure | ||
| Robotic Surgery | Robotic Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 48 hours post-surgery |
| Postoperative Pain at 72 Hours Measured by Visual Analog Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Tejedor Patricia Tejedor, M.D., Ph.D. | Contact | 0034915 86 80 00 | tejedorpat@gmail.com | |
| JoaquÃn Mascaró JoaquÃn Mascaró, M.D. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Tejedor Patricia Tejedor, M.D.,Ph.D. | University Hospital Gregorio Marañón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Gregorio Marañon | Recruiting | Madrid | Spain |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2025 | Feb 11, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2025 | Feb 18, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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). |
| 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. | Intraoperative period |
| Postoperative Analgesic Consumption | Total amount and type of analgesic medication administered during the postoperative hospital stay, including both scheduled and rescue analgesia. | 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. | 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. | 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). | 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 | 1 month post-surgery |
| Quality of Life (QoL) After Surgery | Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30 | 3 month post-surgery |
| Quality of Life (QoL) After Surgery | Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30 | 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). | 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 | 1 month post-surgery |
| Quality of Life (QoL) After Surgery | Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29 | 3 month post-surgery |
| Quality of Life (QoL) After Surgery | Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29 | 6 month post-surgery |
| Quality of Life (QoL) After Surgery | Assessment of patient-reported quality of life using questionnaire EQ5D | 1 month post-surgery |
| Quality of Life (QoL) After Surgery | Assessment of patient-reported quality of life using questionnaire EQ5D | 3 month post-surgery |
| Quality of Life (QoL) After Surgery | Assessment of patient-reported quality of life using questionnaire EQ5D | 6 month post-surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |