Sigmoid, Sigmoid Colon, Neoplasm, CancerWISENCT03135808
Surgical Anatomy and 'Waisting' of the sIgmoid SpEcimen
An observational study of Sigmoid, Sigmoid Colon, Neoplasm, Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Treatment of rectal cancer has improved to the extent that its local recurrence rates are now much lower than other sites in the large bowel. It has been found that higher rates of recurrence in the sigmoid section of the colon, just before the rectum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sigmoid, Sigmoid Colon, Neoplasm, Cancer
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 May 2017to 13 Jun 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 years with rectal or sigmoid cancer who will be undergoing left sided colorectal resection including the anterior peritoneal reflection.
Who may be able to join
- Patients over the age of 18 years with rectal or sigmoid cancer who will be undergoing left sided colorectal resection including the anterior peritoneal reflection.
- Patients must be able to undergo colonoscopy, adequate bowel preparation, MRI and surgery.
Who cannot join
- Patients who are unable to consent, withhold consent or withdraw consent, including patients who require an emergency operation and will be unable to give informed consent
- Contraindication to MRI as per MHRA recommendations [36] eg implanted medical devices, severe claustrophobia
- Distortion of the sigmoid mesentery due to tumour perforation, invasion (stage T4), or extreme bulk
Trial locations and contacts
1 site in 1 country.
About this study
Treatment of rectal cancer has improved to the extent that its local recurrence rates are now much lower than other sites in the large bowel. It has been found that higher rates of recurrence in the sigmoid section of the colon, just before the rectum. This might be due to a narrowing in the bowel, and difficulties identifying whether cancers are in the sigmoid or rectum. The aim is to investigate the bowel from 20 patients undergoing surgery for left sided colorectal cancer at the Royal Marsden. These patients would have routine investigations and treatments, but once the bowel has been removed, it would undergo a MRI scan and additional slices and photography during pathological analysis.
Read the detailed description
Following surgery for a primary cancer (ie has not spread), the patient may still die from the cancer. This may be due to local or distant recurrence. Local recurrence will be near the site of the surgery; for bowel cancer, this may be at the site of the joined bowel or nearby in the abdomen. Distant recurrence will be elsewhere in the body.
Local recurrence is much more likely when there is incomplete removal of all the cancer cells at the time of surgery This can occur if the surrounding tissue, such as the bowel mesentery, is not completely removed. The bowel mesentery is the fatty tissue in which blood vessels and lymph nodes travel up to the bowel. During research into rectal cancer, it was established that there was a rectal mesentery "waist" or narrowing that made it difficult with conventional surgery to remove all the cancer cells. A modified operation gave much better cancer clearance.
Rectal cancer outcomes are now superior to other sites of large bowel cancer. Data from the Royal Marsden and elsewhere show that local recurrence rates of the sigmoid colon are approximately double that of the rectum. This may be due to 2 potential issues: a sigmoid waist, and difficulties in differentiating rectal and sigmoid cancers.
This recurrence may be due to the presence of a waist in the sigmoid mesentery. A case series from Leeds has shown initial data suggesting there is a significantly smaller area in this area. However, this study was underpowered and not conducted prospectively in a scientifically rigorous manner. If a waist was present that could prevent cancer being successfully removed, then an extended operation could be performed or radiotherapy/chemotherapy given before the operation to shrink the cancer.
The sigmoid colon is the section of bowel before the rectum. They can be differentiated by examining the bowel during or after the operation for specific landmarks (taenia coli, appendices epiploicae) that are present on the sigmoid but not on the rectum. However, these landmarks cannot be seen on a patient's pre-operative scans, making it is very difficult to tell whether a cancer is in the sigmoid or the rectum. At our institution, we use MRI to define the end of the sigmoid at MRI as the transition point from the sigmoid mesocolon to the mesorectal apex. This can be seen on sagittal views between the fanning branches of the sigmoid artery proximally and the superior rectal vein distally. On axial views, it can be seen when the rectum fixed posteriorly by the mesorectum transitions into the sigmoid hanging freely on the sigmoid mesocolon. If the distance from the anterior peritoneal reflection to the mesorectal apex on MRI or the coalescence of the taenia coli on histology correlate, it can be predicted pre-operatively on MRI whether a patient's cancer is in the sigmoid or the rectum, and what kind of treatment they should undergo.
- Conditions
- Sigmoid, Sigmoid Colon, Neoplasm, Cancer
- Keywords
- MRI, Imaging,, Anatomy, Tissue, Colorectal, Sigmoid, Colon, Pathology
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Height from peritoneal reflection to the mesorectal apex in mm, from the pathology specimen.
Photographs will be captured of the macroscopic whole specimen and serial cross sectional slices using a high definition camera and will be used to perform the necessary measurements for the study.
Measured: 48 hours post-surgery
The area of tissue in mm2 within the mesentery, from the pathology specimen.
Photographs will be captured of the macroscopic whole specimen and serial cross
Measured: 48 hours post-surgery
Secondary outcomes (7)
Distance in mm from the anterior peritoneal reflection to the rectosigmoid junction on MRI (mesorectal apex, insertion of the superior rectal artery, sacral promontory, inferior border of S2) vs pathology specimen (coalescence of taenia coli).
Photographs will be captured of the macroscopic whole specimen and serial cross sectional slices using a high definition camera and will be used to perform the necessary measurements for the study.
Measured: 48 hours post-surgery
Height from peritoneal reflection to the mesorectal apex in mm, on MRI vs pathology specimen.
Photographs will be captured of the macroscopic whole specimen and serial cross sectional slices using a high definition camera and will be used to perform the necessary measurements for the study.
Measured: 48 hours post-surgery
The area in mm2 of tissue within the mesentery, on MRI vs pathology specimen.
Photographs will be captured of the macroscopic whole specimen and serial cross sectional slices using a high definition camera and will be used to perform the necessary measurements for the study.
Measured: 48 hours post-surgery
Height from peritoneal reflection to the mesorectal apex in mm by location (anterior, posterior, left and right lateral), on MRI vs pathology specimen.
Photographs will be captured of the macroscopic whole specimen and serial cross sectional slices using a high definition camera and will be used to perform the necessary measurements for the study.
Measured: 48 hours post-surgery
The area of tissue in mm2 within the mesentery by location (anterior, posterior, left and right lateral), on MRI vs pathology specimen.
Photographs will be captured of the macroscopic whole specimen and serial cross sectional slices using a high definition camera and will be used to perform the necessary measurements for the study.
Measured: 48 hours post-surgery
Height from peritoneal reflection to the mesorectal apex in mm, by compass direction, on MRI vs pathology specimen.
Photographs will be captured of the macroscopic whole specimen and serial cross sectional slices using a high definition camera and will be used to perform the necessary measurements for the study.
Measured: 48 hours post-surgery
The diameter in mm of tissue within the mesentery by compass direction, on MRI vs pathology specimen.
Photographs will be captured of the macroscopic whole specimen and serial cross sectional slices using a high definition camera and will be used to perform the necessary measurements for the study.
Measured: 48 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start18 May 2017
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sigmoid, Sigmoid Colon, Neoplasm, CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Gina Brown, Principal investigator, Consultant Radiologist and Professor in Cancer Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135808
- Sponsor's protocol ID
- CCR4686
- Acronym
- WISE
- Status last verified
- Sep 2018
- First submitted
- 5 Apr 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Anatomy and 'Waisting' of the sIgmoid SpEcimen
- ClinicalTrials.gov ID
- NCT03135808
- Acronym / sponsor ID
- WISE / CCR4686
- Conditions
- Sigmoid, Sigmoid Colon, Neoplasm, Cancer
- Keywords
- MRI, Imaging,, Anatomy, Tissue, Colorectal, Sigmoid, Colon, Pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Study start
- 18 May 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 1 May 2017 (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.
Treatment of rectal cancer has improved to the extent that its local recurrence rates are now much lower than other sites in the large bowel. It has been found that higher rates of recurrence in the sigmoid section of the colon, just before the rectum. This might be due to a narrowing in the bowel, and difficulties identifying whether cancers are in the sigmoid or rectum. The aim is to investigate the bowel from 20 patients undergoing surgery for left sided colorectal cancer at the Royal Marsden. These patients would have routine investigations and treatments, but once the bowel has been removed, it would undergo a MRI scan and additional slices and photography during pathological analysis.
Detailed description
Following surgery for a primary cancer (ie has not spread), the patient may still die from the cancer. This may be due to local or distant recurrence. Local recurrence will be near the site of the surgery; for bowel cancer, this may be at the site of the joined bowel or nearby in the abdomen. Distant recurrence will be elsewhere in the body.
Local recurrence is much more likely when there is incomplete removal of all the cancer cells at the time of surgery This can occur if the surrounding tissue, such as the bowel mesentery, is not completely removed. The bowel mesentery is the fatty tissue in which blood vessels and lymph nodes travel up to the bowel. During research into rectal cancer, it was established that there was a rectal mesentery "waist" or narrowing that made it difficult with conventional surgery to remove all the cancer cells. A modified operation gave much better cancer clearance.
Rectal cancer outcomes are now superior to other sites of large bowel cancer. Data from the Royal Marsden and elsewhere show that local recurrence rates of the sigmoid colon are approximately double that of the rectum. This may be due to 2 potential issues: a sigmoid waist, and difficulties in differentiating rectal and sigmoid cancers.
This recurrence may be due to the presence of a waist in the sigmoid mesentery. A case series from Leeds has shown initial data suggesting there is a significantly smaller area in this area. However, this study was underpowered and not conducted prospectively in a scientifically rigorous manner. If a waist was present that could prevent cancer being successfully removed, then an extended operation could be performed or radiotherapy/chemotherapy given before the operation to shrink the cancer.
The sigmoid colon is the section of bowel before the rectum. They can be differentiated by examining the bowel during or after the operation for specific landmarks (taenia coli, appendices epiploicae) that are present on the sigmoid but not on the rectum. However, these landmarks cannot be seen on a patient's pre-operative scans, making it is very difficult to tell whether a cancer is in the sigmoid or the rectum. At our institution, we use MRI to define the end of the sigmoid at MRI as the transition point from the sigmoid mesocolon to the mesorectal apex. This can be seen on sagittal views between the fanning branches of the sigmoid artery proximally and the superior rectal vein distally. On axial views, it can be seen when the rectum fixed posteriorly by the mesorectum transitions into the sigmoid hanging freely on the sigmoid mesocolon. If the distance from the anterior peritoneal reflection to the mesorectal apex on MRI or the coalescence of the taenia coli on histology correlate, it can be predicted pre-operatively on MRI whether a patient's cancer is in the sigmoid or the rectum, and what kind of treatment they should undergo.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 years with rectal or sigmoid cancer who will be undergoing left sided colorectal resection including the anterior peritoneal reflection.
Key inclusion criteria (2 listed)
- Patients over the age of 18 years with rectal or sigmoid cancer who will be undergoing left sided colorectal resection including the anterior peritoneal reflection.
- Patients must be able to undergo colonoscopy, adequate bowel preparation, MRI and surgery.
Key exclusion criteria (3 listed)
- Patients who are unable to consent, withhold consent or withdraw consent, including patients who require an emergency operation and will be unable to give informed consent
- Contraindication to MRI as per MHRA recommendations [36] eg implanted medical devices, severe claustrophobia
- Distortion of the sigmoid mesentery due to tumour perforation, invasion (stage T4), or extreme bulk
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
Height from peritoneal reflection to the mesorectal apex in mm, from the pathology specimen.
Time frame: 48 hours post-surgery
Photographs will be captured of the macroscopic whole specimen and serial cross sectional slices using a high definition camera and will be used to perform the necessary measurements for the study.
The area of tissue in mm2 within the mesentery, from the pathology specimen.
Time frame: 48 hours post-surgery
Photographs will be captured of the macroscopic whole specimen and serial cross
7 secondary outcomes
Distance in mm from the anterior peritoneal reflection to the rectosigmoid junction on MRI (mesorectal apex, insertion of the superior rectal artery, sacral promontory, inferior border of S2) vs pathology specimen (coalescence of taenia coli).
Time frame: 48 hours post-surgery
Height from peritoneal reflection to the mesorectal apex in mm, on MRI vs pathology specimen.
Time frame: 48 hours post-surgery
The area in mm2 of tissue within the mesentery, on MRI vs pathology specimen.
Time frame: 48 hours post-surgery
Height from peritoneal reflection to the mesorectal apex in mm by location (anterior, posterior, left and right lateral), on MRI vs pathology specimen.
Time frame: 48 hours post-surgery
The area of tissue in mm2 within the mesentery by location (anterior, posterior, left and right lateral), on MRI vs pathology specimen.
Time frame: 48 hours post-surgery
Height from peritoneal reflection to the mesorectal apex in mm, by compass direction, on MRI vs pathology specimen.
Time frame: 48 hours post-surgery
The diameter in mm of tissue within the mesentery by compass direction, on MRI vs pathology specimen.
Time frame: 48 hours post-surgery
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 14 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Gina Brown principal investigator
Consultant Radiologist and Professor in Cancer Imaging
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 Sigmoid, Sigmoid Colon, Neoplasm, Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 3 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 14 Sep 2018. 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 United Kingdom. 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?
Height from peritoneal reflection to the mesorectal apex in mm, from the pathology specimen. (time frame: 48 hours post-surgery). The study lists 2 primary outcomes in all. 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 14 Sep 2018.