Actively Recruiting

Age: 18Years +
All Genders
NCT07431892

Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures

Led by Hospital Central de la Defensa Gómez Ulla · Updated on 2026-02-25

80

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 classification I, II, or III
  • Elective colon surgery (right or left hemicolectomy) for malignant disease
  • Planned laparoscopic or robotic surgical approach
  • Completed preoperative evaluation as per RICA protocol (nutritional, nursing, anesthetic, and pharmacy assessments)
Not Eligible

You will not qualify if you...

  • Patients planned for open surgery
  • Patients undergoing rectal surgery without protective stoma
  • Patients with inflammatory bowel disease requiring colorectal resection
  • Patients needing multivisceral resection identified during surgery
  • Extraction incision not using Pfannenstiel approach
  • Current or past chronic opioid use or abuse
  • Current or past benzodiazepine use or abuse
  • Chronic analgesic use for other medical conditions
  • Current or past recreational drug use or abuse
  • Non-compliance with the RICA protocol, including missing preoperative evaluations or non-adherence to care protocols

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Gregorio Marañon

Madrid, Spain

Actively Recruiting

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Research Team

P

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

CONTACT

J

Joaquín Mascaró Joaquín Mascaró, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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