Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures (PEARL)

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.

Study Overview

• Status: Recruiting
• Conditions: Minimally Invasive Surgical Procedures; Colon Cancer Patients

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Patricia Tejedor Patricia Tejedor, M.D., Ph.D.; Phone Number: 0034915 86 80 00; Email: tejedorpat@gmail.com
• Study Contact Backup: Name: Joaquín Mascaró Joaquín Mascaró, M.D.

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • University Hospital Gregorio Marañon
    • Contact: Patricia Tejedor Tejedor, M.D., Ph.D.; Phone Number: 0034609700386; Email: patricia.tejedor@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Laparoscopic Surgery; Laparoscopic procedure
Robotic Surgery; Robotic Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Hospital Central de la Defensa Gómez Ulla
• Investigators: Principal Investigator: Patricia Tejedor Patricia Tejedor, M.D.,Ph.D., University Hospital Gregorio Marañon

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 1, 2025
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: colorectal surgery; laparoscopic surgery; postoperative pain; minimally invasive surgery; robotic surgery; Nociception Level Index (NOL)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: CR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No