Minimally Invasive Surgical ProceduresPEARLNCT07431892
Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures
An observational study of Minimally Invasive Surgical Procedures and Colon Cancer Patients, run by Hospital Central de la Defensa Gómez Ulla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimally Invasive Surgical Procedures, Colon Cancer Patients
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 1 Sep 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joaquín Mascaró Joaquín Mascaró, M.D. contact
Spain1 site, 1 recruiting
- Recruiting
University Hospital Gregorio Marañon
Madrid
Patricia Tejedor Tejedor, M.D., Ph.D., 0034609700386, patricia.tejedor@hotmail.com
About this study
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.
Read more
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.
Read the detailed description
This is a prospective, single-center, observational study conducted at the Hospital General Universitario Gregorio Marañón in Madrid, Spain. The study compares postoperative pain outcomes in patients undergoing elective colorectal surgery via two different minimally invasive surgical approaches: laparoscopic and robotic-assisted surgery.
Eligible participants will be adults (≥18 years) undergoing elective colon or rectal surgery for benign or malignant disease, provided they meet the criteria of the hospital's Enhanced Recovery After Surgery (ERAS) program, known locally as the RICA protocol. Patients with open surgery indications, chronic analgesic use, or other exclusion criteria (e.g., inflammatory bowel disease, multivisceral resections, chronic opioid use, or inability to follow the RICA protocol) will not be included.
Pain will be assessed using the Visual Analog Scale (VAS) at standardized time points: on arrival at the post-anesthesia care unit, upon admission to the surgical ward, and at 24, 48, and 72 hours postoperatively, as well as at discharge. Intraoperative nociception will also be evaluated using the Nociception Level Index (NOL), an objective measure that reflects the patient's pain response during surgery.
Additional outcomes include postoperative opioid consumption, length of hospital stay, complication rates (using the Clavien-Dindo classification), hospital readmissions, reintervention rates, and patient-reported quality of life measures at 1, 3, 6, and 12 months after surgery, using validated questionnaires (QLQ-C30, QLQ-CR29, and EQ-5D).
Data will be collected and stored securely using the REDCap electronic data capture system, ensuring patient confidentiality. The estimated sample size is 80 patients (approximately 40 in each group), and the total study duration is expected to be 2 years for recruitment and follow-up, with an additional period for data analysis and publication.
The goal is to generate high-quality evidence to help guide clinical decision-making in the selection of surgical approaches for colorectal surgery, focusing on reducing postoperative pain and enhancing recovery.
- Keywords
- colorectal surgery, minimally invasive surgery, robotic surgery, laparoscopic surgery, postoperative pain, Nociception Level Index (NOL)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Surgery | Laparoscopic procedure | |
| Robotic Surgery | Robotic Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours
Secondary outcomes (17)
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).
Measured: 48 hours post-surgery
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).
Measured: 72 hours post-surgery
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.
Measured: Intraoperative period
Postoperative Analgesic Consumption
Total amount and type of analgesic medication administered during the postoperative hospital stay, including both scheduled and rescue analgesia.
Measured: From recovery room admission up to 72 hours after surgery.
Postoperative Morbidity (Clavien-Dindo Classification)
Incidence and severity of postoperative complications up to 30 days after surgery, categorized according to the Clavien-Dindo classification system. Patients without complications will be recorded as Grade 0. Complications will be graded from Grade I (minor deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, or radiological interventions) to Grade V (death of the patient). The minimum possible value is 0 and the maximum possible value is V. Higher grades reflect greater severity of complications and therefore worse clinical outcomes.
Measured: Within 30 days after surgery
Conversion Rate to Open Surgery
Number and percentage of patients requiring conversion from laparoscopic or robotic approach to open surgery during the procedure.
Measured: Intraoperative period
Postoperative Inflammatory Response
Measurement of postoperative systemic inflammatory markers including C-reactive protein (CRP), at predefined postoperative time points (e.g., 24h and 48h).
Measured: Within the first 48 hours post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30
Measured: 1 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30
Measured: 3 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-C30
Measured: 6 month post-surgery
Postoperative Inflammatory Response
Measurement of postoperative systemic inflammatory markers including procalcitonin at predefined postoperative time points (e.g., 24h and 48h).
Measured: Within the first 48 hours post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29
Measured: 1 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29
Measured: 3 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EORTC QLQ-CR29
Measured: 6 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EQ5D
Measured: 1 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EQ5D
Measured: 3 month post-surgery
Quality of Life (QoL) After Surgery
Assessment of patient-reported quality of life using questionnaire EQ5D
Measured: 6 month post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Sep 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital Central de la Defensa Gómez Ulla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Tejedor, University Hospital Gregorio Marañón
- Investigators
- Patricia Tejedor Patricia Tejedor, M.D.,Ph.D., Principal investigator, University Hospital Gregorio Marañón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431892
- Sponsor's protocol ID
- CR001
- Acronym
- PEARL
- Status last verified
- Feb 2026
- First submitted
- 1 Jul 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Evaluation Across Robotic and Laparoscopic Surgery for Colorectal Procedures
- ClinicalTrials.gov ID
- NCT07431892
- Acronym / sponsor ID
- PEARL / CR001
- Keywords
- colorectal surgery, minimally invasive surgery, robotic surgery, laparoscopic surgery, postoperative pain, Nociception Level Index (NOL)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Central de la Defensa Gómez UllaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-center, observational study conducted at the Hospital General Universitario Gregorio Marañón in Madrid, Spain. The study compares postoperative pain outcomes in patients undergoing elective colorectal surgery via two different minimally invasive surgical approaches: laparoscopic and robotic-assisted surgery.
Eligible participants will be adults (≥18 years) undergoing elective colon or rectal surgery for benign or malignant disease, provided they meet the criteria of the hospital's Enhanced Recovery After Surgery (ERAS) program, known locally as the RICA protocol. Patients with open surgery indications, chronic analgesic use, or other exclusion criteria (e.g., inflammatory bowel disease, multivisceral resections, chronic opioid use, or inability to follow the RICA protocol) will not be included.
Pain will be assessed using the Visual Analog Scale (VAS) at standardized time points: on arrival at the post-anesthesia care unit, upon admission to the surgical ward, and at 24, 48, and 72 hours postoperatively, as well as at discharge. Intraoperative nociception will also be evaluated using the Nociception Level Index (NOL), an objective measure that reflects the patient's pain response during surgery.
Additional outcomes include postoperative opioid consumption, length of hospital stay, complication rates (using the Clavien-Dindo classification), hospital readmissions, reintervention rates, and patient-reported quality of life measures at 1, 3, 6, and 12 months after surgery, using validated questionnaires (QLQ-C30, QLQ-CR29, and EQ-5D).
Data will be collected and stored securely using the REDCap electronic data capture system, ensuring patient confidentiality. The estimated sample size is 80 patients (approximately 40 in each group), and the total study duration is expected to be 2 years for recruitment and follow-up, with an additional period for data analysis and publication.
The goal is to generate high-quality evidence to help guide clinical decision-making in the selection of surgical approaches for colorectal surgery, focusing on reducing postoperative pain and enhancing recovery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Surgery | – | –Laparoscopic procedure |
| Robotic Surgery | – | –Robotic Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Pain
Time frame: 24 hours
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).
17 secondary outcomes
Postoperative Pain at 48 Hours Measured by Visual Analog Scale (VAS)
Time frame: 48 hours post-surgery
Postoperative Pain at 72 Hours Measured by Visual Analog Scale (VAS)
Time frame: 72 hours post-surgery
Intraoperative Analgesic Consumption
Time frame: Intraoperative period
Postoperative Analgesic Consumption
Time frame: From recovery room admission up to 72 hours after surgery.
Postoperative Morbidity (Clavien-Dindo Classification)
Time frame: Within 30 days after surgery
Conversion Rate to Open Surgery
Time frame: Intraoperative period
Postoperative Inflammatory Response
Time frame: Within the first 48 hours post-surgery
Quality of Life (QoL) After Surgery
Time frame: 1 month post-surgery
Quality of Life (QoL) After Surgery
Time frame: 3 month post-surgery
Quality of Life (QoL) After Surgery
Time frame: 6 month post-surgery
Postoperative Inflammatory Response
Time frame: Within the first 48 hours post-surgery
Quality of Life (QoL) After Surgery
Time frame: 1 month post-surgery
Quality of Life (QoL) After Surgery
Time frame: 3 month post-surgery
Quality of Life (QoL) After Surgery
Time frame: 6 month post-surgery
Quality of Life (QoL) After Surgery
Time frame: 1 month post-surgery
Quality of Life (QoL) After Surgery
Time frame: 3 month post-surgery
Quality of Life (QoL) After Surgery
Time frame: 6 month post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joaquín Mascaró Joaquín Mascaró, M.D. contact
Patricia Tejedor Patricia Tejedor, M.D.,Ph.D. principal investigator
University Hospital Gregorio Marañón
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimally Invasive Surgical Procedures and Colon Cancer Patients, run by Hospital Central de la Defensa Gómez Ulla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Tejedor Patricia Tejedor, M.D., Ph.D. (0034915 86 80 00, tejedorpat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.