Endoscopy Clinical Trials

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Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Spain
University Hospital Gregorio Marañon
RECRUITING
Madrid
Contact Information
Primary
Patricia Tejedor Patricia Tejedor, M.D., Ph.D.
tejedorpat@gmail.com
0034915 86 80 00
Backup
Joaquín Mascaró Joaquín Mascaró, M.D.
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 80
Treatments
Laparoscopic Surgery
Laparoscopic procedure
Robotic Surgery
Robotic Procedure
Related Therapeutic Areas
Sponsors
Leads: Hospital Central de la Defensa Gómez Ulla

This content was sourced from clinicaltrials.gov

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