Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures
PEARL
PEARL
Sponsor study identifier
observational
80
1 country
1
Study Start
September 1, 2025
Actual (reported)Primary Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2025
Actual (reported)September 1, 2025
Actual (reported)February 25, 2026
Actual (reported)February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Laparoscopic procedure
Robotic Procedure
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.
University Hospital Gregorio Marañon
Madrid, Spain
Patricia Tejedor Patricia Tejedor, M.D.,Ph.D.
University Hospital Gregorio Marañón
Joaquín Mascaró Joaquín Mascaró, M.D.
CONTACT
First Submitted
July 1, 2025
First Posted
February 25, 2026
Study Start
September 1, 2025
Actual (reported)Primary Completion
February 28, 2026
Estimated (date passed)Learning Curve for Minimally Invasive Oesophagectomy and Contrast With Open Procedure
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 25, 2026
Record last verified: 2026-02
Individual participant data (IPD) will not be shared due to patient confidentiality concerns and institutional data protection policies. Additionally, the study is single-center with a limited sample size, and there is no formal data-sharing infrastructure or repository in place for this project.
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Source: ClinicalTrials.gov.
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