Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Central de la Defensa Gómez Ulla
About this trial
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
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Signed informed consent
Adequate cognitive status
ASA (American Society of Anesthesiologists) classification I, II, or III
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Laparoscopic Surgery
Group B: Robotic Surgery
Trial outcomes
Primary outcomes
1
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).
Time frame
24 hoursSecondary outcomes
1
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).
Time frame
48 hours post-surgery2
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).
Time frame
72 hours post-surgery3
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.
Time frame
Intraoperative period4
Postoperative Analgesic Consumption
Total amount and type of analgesic medication administered during the postoperative hospital stay, including both scheduled and rescue analgesia.
Time frame
From recovery room admission up to 72 hours after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Central de la Defensa Gómez Ulla
Lead sponsor
University Hospital Gregorio Marañón
Sponsor institution
Source ClinicalTrials.gov