Locally Advanced Rectal CancerAPR-IMMNCT04324567
Inflammation After Laparoscopic Robot-assisted Surgery for Locally Advanced Rectal Cancer
An observational study of Locally Advanced Rectal Cancer and Abdominoperineal Resection, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The intention of the study is to explore metabolic and inflammatory parameters in the pelvis and systemically after abdominoperineal resection (APR) for locally advanced rectal cancer (LARC) in patients that have received radiation therapy before surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Locally Advanced Rectal Cancer, Abdominoperineal Resection
- How many people
- 55 participants
- Where
- 1 siteNorway
- Study dates
- 9 Oct 2019to 5 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced rectal cancer who receive radiotherapy >25 Gy prior to surgery.
Who may be able to join
- Patients with primary rectal adenocarcinoma that have received radiation ≥25 Gy to the pelvis.
- operation with APR with laparoscopic robot assisted technique.
- have accepted and signed the consent form.
Who cannot join
- APR for other reasons
Trial locations and contacts
1 site in 1 country.
About this study
The intention of the study is to explore metabolic and inflammatory parameters in the pelvis and systemically after abdominoperineal resection (APR) for locally advanced rectal cancer (LARC) in patients that have received radiation therapy before surgery. In this study the inflammatory response after laparoscopic robot-assisted APR for LARC will be compared to results obtained in a recent cohort of patients operated with open APR for LARC, which will serve as the control population.
Read the detailed description
Locally advanced rectal cancers (LARC) threaten the normal surgical margins and therefore needs neoadjuvant (chemo-) radiotherapy to down-stage the tumor before surgery. The Norwegian Radium Hospital Oslo University Hospital is a regional center for treatment of LARC in the south-eastern part of Norway and treat approximately 80-100 patients in this category annually. About 50 of these patients receive abdominoperineal resection (APR) as the main surgical treatment.
Laparoscopic surgery in LARC has been limited because of difficult dissection with straight instruments outside the normal anatomical planes in the confined space of the pelvis. However, recent papers report on better feasibility and good results in robot-assisted surgery for LARC. In respect to shorter postoperative length of stay for minimally invasive compared to open surgery, reduced inflammation may be the explanation, however, results are not conclusive. Most studies comparing open to minimally invasive surgery in colorectal cancer have had conventional laparoscopy as the minimally invasive group, including studies comparing inflammation after surgery. A study on inflammation after laparoscopic robot-assisted major surgery for bladder cancer has recently been published, but to our knowledge no comprehensive studies have been done with patients with rectal cancer resections. Additionally, there are claims that excessive and/or dysregulated inflammatory response after cancer surgery, worsen oncologic outcome. The need to characterize the inflammatory response after laparoscopic robot-assisted surgery of rectal cancer is thus highly relevant and needed.
The investigators want to analyse inflammatory parameters in plasma and peritoneal fluid in patients undergoing robot-assisted and open surgery for LARC.
Microdialysis is a technique which enables close to real-time monitoring of the tissues and organs of interest. The investigators want to utilize the microdialysis method to describe and monitor metabolic and inflammatory parameters in some patients after extensive robot-assisted oncological surgery for LARC.
The investigators hypothesize inflammatory response differ between patients undergoing open versus robot-assisted surgery.
- Keywords
- Microdialysis, Inflammatory Response
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 |
|---|---|---|
| APR-open | Patients with locally advanced rectal cancer treated with neoadjuvant (chemo-) radiotherapy (CRT) and operated with abdominoperineal resection (APR) with laparotomy. | |
| APR-robot | Patients with locally advanced rectal cancer treated with neoadjuvant (chemo-) radiotherapy (CRT) and operated with abdominoperineal resection (APR) with laparoscopic robot assisted technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak value of surgically induced C-reactive protein (CRP), expected to occur 1-3 days after surgery
CRP will be measured prior to surgery as well as on a daily basis the first 4 postoperative days. Peak values of CRP will be compared between patients undergoing open versus robot-assisted surgery.
Measured: December 2022
Secondary outcomes (7)
Overall survival at 1 year follow up after surgery
Differences between patients undergoing open versus robot-assisted surgery will be registered.
Measured: December 2024
Progression-free survival at 1 year follow up after surgery
Differences between patients undergoing open versus robot-assisted surgery will be registered
Measured: December 2024
Operating time in minutes
Differences between patients undergoing open versus robot-assisted surgery will be registered
Measured: December 2023
Hospital length of stay in days after primary surgery
Differences between patients undergoing open versus robot-assisted surgery will be registered
Measured: December 2023
Postoperative deep pelvic surgical site infection within 30 days after primary surgery
Differences between patients undergoing open versus robot-assisted surgery will be registered. Clinical diagnose (yes/no) supported by CT-scan
Measured: December 2023
Superficial wound infection within 30 days after primary surgery
Differences between patients undergoing open versus robot-assisted surgery will be registered. Clinical diagnose (yes/no)
Measured: December 2023
Dehiscence of the perineal wound at 3 months follow-up
Differences between patients undergoing open versus robot-assisted surgery will be registered. Clinical diagnose (yes/no)
Measured: December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start9 Oct 2019
- Primary completion5 Mar 2022
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Ebbe Billmann Thorgersen, Oslo University Hospital
- Investigators
- Ebbe B Thorgersen, MD PhD, Principal investigator, Surgeon, The Department of Gastroenterological Surgery, The Norwegian Radium Hospital, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324567
- Sponsor's protocol ID
- 2019/810
- Acronym
- APR-IMM
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2020
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation After Laparoscopic Robot-assisted Surgery for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT04324567
- Acronym / sponsor ID
- APR-IMM / 2019/810
- Keywords
- Microdialysis, Inflammatory Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 5 Mar 2022 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 27 Mar 2020 (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.
The intention of the study is to explore metabolic and inflammatory parameters in the pelvis and systemically after abdominoperineal resection (APR) for locally advanced rectal cancer (LARC) in patients that have received radiation therapy before surgery. In this study the inflammatory response after laparoscopic robot-assisted APR for LARC will be compared to results obtained in a recent cohort of patients operated with open APR for LARC, which will serve as the control population.
Detailed description
Locally advanced rectal cancers (LARC) threaten the normal surgical margins and therefore needs neoadjuvant (chemo-) radiotherapy to down-stage the tumor before surgery. The Norwegian Radium Hospital Oslo University Hospital is a regional center for treatment of LARC in the south-eastern part of Norway and treat approximately 80-100 patients in this category annually. About 50 of these patients receive abdominoperineal resection (APR) as the main surgical treatment.
Laparoscopic surgery in LARC has been limited because of difficult dissection with straight instruments outside the normal anatomical planes in the confined space of the pelvis. However, recent papers report on better feasibility and good results in robot-assisted surgery for LARC. In respect to shorter postoperative length of stay for minimally invasive compared to open surgery, reduced inflammation may be the explanation, however, results are not conclusive. Most studies comparing open to minimally invasive surgery in colorectal cancer have had conventional laparoscopy as the minimally invasive group, including studies comparing inflammation after surgery. A study on inflammation after laparoscopic robot-assisted major surgery for bladder cancer has recently been published, but to our knowledge no comprehensive studies have been done with patients with rectal cancer resections. Additionally, there are claims that excessive and/or dysregulated inflammatory response after cancer surgery, worsen oncologic outcome. The need to characterize the inflammatory response after laparoscopic robot-assisted surgery of rectal cancer is thus highly relevant and needed.
The investigators want to analyse inflammatory parameters in plasma and peritoneal fluid in patients undergoing robot-assisted and open surgery for LARC.
Microdialysis is a technique which enables close to real-time monitoring of the tissues and organs of interest. The investigators want to utilize the microdialysis method to describe and monitor metabolic and inflammatory parameters in some patients after extensive robot-assisted oncological surgery for LARC.
The investigators hypothesize inflammatory response differ between patients undergoing open versus robot-assisted surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APR-open | – | –Patients with locally advanced rectal cancer treated with neoadjuvant (chemo-) radiotherapy (CRT) and operated with abdominoperineal resection (APR) with laparotomy. |
| APR-robot | – | –Patients with locally advanced rectal cancer treated with neoadjuvant (chemo-) radiotherapy (CRT) and operated with abdominoperineal resection (APR) with laparoscopic robot assisted technique. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced rectal cancer who receive radiotherapy >25 Gy prior to surgery.
Key inclusion criteria (3 listed)
- Patients with primary rectal adenocarcinoma that have received radiation ≥25 Gy to the pelvis.
- operation with APR with laparoscopic robot assisted technique.
- have accepted and signed the consent form.
Key exclusion criteria (1 listed)
- APR for other reasons
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
Peak value of surgically induced C-reactive protein (CRP), expected to occur 1-3 days after surgery
Time frame: December 2022
CRP will be measured prior to surgery as well as on a daily basis the first 4 postoperative days. Peak values of CRP will be compared between patients undergoing open versus robot-assisted surgery.
7 secondary outcomes
Overall survival at 1 year follow up after surgery
Time frame: December 2024
Progression-free survival at 1 year follow up after surgery
Time frame: December 2024
Operating time in minutes
Time frame: December 2023
Hospital length of stay in days after primary surgery
Time frame: December 2023
Postoperative deep pelvic surgical site infection within 30 days after primary surgery
Time frame: December 2023
Superficial wound infection within 30 days after primary surgery
Time frame: December 2023
Dehiscence of the perineal wound at 3 months follow-up
Time frame: December 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
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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. This study is not recruiting at the moment.
Ebbe B Thorgersen, MD PhD principal investigator
Surgeon, The Department of Gastroenterological Surgery, The Norwegian Radium Hospital, Oslo University Hospital
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 Locally Advanced Rectal Cancer and Abdominoperineal Resection, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 3 Apr 2023. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak value of surgically induced C-reactive protein (CRP), expected to occur 1-3 days after surgery (time frame: December 2022). 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 3 Apr 2023.