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Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures

Recruitingn/aAges 18 Years - anyAllHospital Central de la Defensa Gómez Ulla
NCT07431892 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 m

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📋 Eligibility rules (as published)
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)
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What it tests

  • Not listed
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Where

1 site
University Hospital Gregorio Marañon
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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