Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures

NCT07431892 | Recruiting DMC

• 1 other identifier: CR001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Minimally Invasive Surgical Procedures; Colon Cancer Patients

Keywords

colorectal surgery; minimally invasive surgery; robotic surgery; laparoscopic surgery; postoperative pain; Nociception Level Index (NOL)

Outcome Measures

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).

  24 hours

Secondary Outcomes (17)

• Postoperative Pain at 48 Hours Measured by Visual Analog Scale (VAS)

  48 hours post-surgery

• Postoperative Pain at 72 Hours Measured by Visual Analog Scale (VAS)

  72 hours post-surgery

• Intraoperative Analgesic Consumption

  Intraoperative period

• Postoperative Analgesic Consumption

  From recovery room admission up to 72 hours after surgery.

• Postoperative Morbidity (Clavien-Dindo Classification)

  Within 30 days after surgery

Study Arms (2)

Laparoscopic Surgery

Laparoscopic procedure

Robotic Surgery

Robotic Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults aged 18 years or older
• Signed informed consent
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Central de la Defensa Gómez Ulla: lead

Study Sites (1)

University Hospital Gregorio Marañon

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Patricia Tejedor Patricia Tejedor, M.D.,Ph.D.

  University Hospital Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Tejedor Patricia Tejedor, M.D., Ph.D.

CONTACT

0034915 86 80 00; tejedorpat@gmail.com

Joaquín Mascaró Joaquín Mascaró, M.D.

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: February 25, 2026
• Study Start: September 1, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)