NCT07431892 Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures
| NCT ID | NCT07431892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Central de la Defensa Gómez Ulla |
| Condition | Minimally Invasive Surgical Procedures |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-09-01 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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)
Contact & Investigator
Patricia Tejedor Patricia Tejedor, M.D.,Ph.D.
PRINCIPAL INVESTIGATOR
University Hospital Gregorio Marañón
Frequently Asked Questions
Who can join the NCT07431892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Minimally Invasive Surgical Procedures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07431892 currently recruiting?
Yes, NCT07431892 is actively recruiting participants. Contact the research team at tejedorpat@gmail.com for enrollment information.
Where is the NCT07431892 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07431892 clinical trial?
NCT07431892 is sponsored by Hospital Central de la Defensa Gómez Ulla. The principal investigator is Patricia Tejedor Patricia Tejedor, M.D.,Ph.D. at University Hospital Gregorio Marañón. The trial plans to enroll 80 participants.