Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:49 PM
Study NCT ID:
NCT07431892
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2025-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-01', 'size': 152778, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-02-11T14:11', 'hasProtocol': True}, {'date': '2025-07-01', 'size': 124562, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-18T03:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2025-07-01', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': '24 hours', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain at 48 Hours Measured by Visual Analog Scale (VAS)', 'timeFrame': '48 hours post-surgery', 'description': '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).'}, {'measure': 'Postoperative Pain at 72 Hours Measured by Visual Analog Scale (VAS)', 'timeFrame': '72 hours post-surgery', 'description': '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).'}, {'measure': 'Intraoperative Analgesic Consumption', 'timeFrame': 'Intraoperative period', 'description': 'Total intraoperative consumption of opioids (fentanyl and remifentanil), recorded in micrograms, as an indirect measure of nociception and analgesic requirements during surgery.'}, {'measure': 'Postoperative Analgesic Consumption', 'timeFrame': 'From recovery room admission up to 72 hours after surgery.', 'description': 'Total amount and type of analgesic medication administered during the postoperative hospital stay, including both scheduled and rescue analgesia.'}, {'measure': 'Postoperative Morbidity (Clavien-Dindo Classification)', 'timeFrame': 'Within 30 days after surgery', 'description': '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.'}, {'measure': 'Conversion Rate to Open Surgery', 'timeFrame': 'Intraoperative period', 'description': 'Number and percentage of patients requiring conversion from laparoscopic or robotic approach to open surgery during the procedure.'}, {'measure': 'Postoperative Inflammatory Response', 'timeFrame': 'Within the first 48 hours post-surgery', 'description': 'Measurement of postoperative systemic inflammatory markers including C-reactive protein (CRP), at predefined postoperative time points (e.g., 24h and 48h).'}, {'measure': 'Quality of Life (QoL) After Surgery', 'timeFrame': '1 month post-surgery', 'description': 'Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30'}, {'measure': 'Quality of Life (QoL) After Surgery', 'timeFrame': '3 month post-surgery', 'description': 'Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30'}, {'measure': 'Quality of Life (QoL) After Surgery', 'timeFrame': '6 month post-surgery', 'description': 'Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30'}, {'measure': 'Postoperative Inflammatory Response', 'timeFrame': 'Within the first 48 hours post-surgery', 'description': 'Measurement of postoperative systemic inflammatory markers including procalcitonin at predefined postoperative time points (e.g., 24h and 48h).'}, {'measure': 'Quality of Life (QoL) After Surgery', 'timeFrame': '1 month post-surgery', 'description': 'Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29'}, {'measure': 'Quality of Life (QoL) After Surgery', 'timeFrame': '3 month post-surgery', 'description': 'Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29'}, {'measure': 'Quality of Life (QoL) After Surgery', 'timeFrame': '6 month post-surgery', 'description': 'Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29'}, {'measure': 'Quality of Life (QoL) After Surgery', 'timeFrame': '1 month post-surgery', 'description': 'Assessment of patient-reported quality of life using questionnaire EQ5D'}, {'measure': 'Quality of Life (QoL) After Surgery', 'timeFrame': '3 month post-surgery', 'description': 'Assessment of patient-reported quality of life using questionnaire EQ5D'}, {'measure': 'Quality of Life (QoL) After Surgery', 'timeFrame': '6 month post-surgery', 'description': 'Assessment of patient-reported quality of life using questionnaire EQ5D'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal surgery', 'minimally invasive surgery', 'robotic surgery', 'laparoscopic surgery', 'postoperative pain', 'Nociception Level Index (NOL)'], 'conditions': ['Minimally Invasive Surgical Procedures', 'Colon Cancer Patients']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nThe 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).\n\nResearchers 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.\n\nAll 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).\n\nThe results could help surgeons and hospitals choose the most effective surgical approach to reduce postoperative pain and improve patient recovery in colorectal surgery.", 'detailedDescription': "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.\n\nEligible 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.\n\nPain 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.\n\nAdditional 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).\n\nData 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Signed informed consent\n* Meeting inclusion requirements of the hospital's Enhanced Recovery Protocol (RICA program), including:\n* Adequate cognitive status\n* ASA (American Society of Anesthesiologists) classification I, II, or III\n* Elective colon surgery (right or left hemicolectomy) for malignant disease\n* Planned laparoscopic or robotic surgical approach\n* Preoperative evaluation completed as per RICA protocol (nutritional, nursing, anesthetic, and pharmacy assessments)\n\nExclusion Criteria:\n\n* Patients with a preoperative decision for open surgery\n* Patients undergoing rectal surgery (partial or total mesorectal excision without protective stoma)\n* Patients with inflammatory bowel disease requiring colorectal resection\n* Patients requiring multivisceral resection due to oncologic indications identified intraoperatively\n* Extraction incision different from Pfannenstiel approach\n* Current or past history of chronic opioid use or opioid abuse\n* Current or past history of benzodiazepine use or abuse\n* Chronic use of analgesics for other comorbid medical conditions\n* Current or past history of recreational drug use or abuse\n* Non-compliance with the RICA protocol, including:\n* Lack of preoperative nutritional, nursing, anesthetic, or pharmacy evaluation\n* Non-adherence to preoperative care protocols (e.g., premedication, fasting, carbohydrate loading, thromboembolism prophylaxis, antibiotic prophylaxis, anesthetic care guidelines)"}, 'identificationModule': {'nctId': 'NCT07431892', 'acronym': 'PEARL', 'briefTitle': 'Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Central de la Defensa Gómez Ulla'}, 'officialTitle': 'Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures', 'orgStudyIdInfo': {'id': 'CR001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laparoscopic Surgery', 'description': 'Laparoscopic procedure'}, {'label': 'Robotic Surgery', 'description': 'Robotic Procedure'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Patricia Tejedor Tejedor, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'patricia.tejedor@hotmail.com', 'phone': '0034609700386'}], 'facility': 'University Hospital Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Patricia Tejedor Patricia Tejedor, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'tejedorpat@gmail.com', 'phone': '0034915 86 80 00'}, {'name': 'Joaquín Mascaró Joaquín Mascaró, M.D.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Patricia Tejedor Patricia Tejedor, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Gregorio Marañón'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Central de la Defensa Gómez Ulla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Patricia Tejedor', 'investigatorAffiliation': 'University Hospital Gregorio Marañón'}}}}