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AzTrials

Rectal CancerNCT04293835

Sigmoid Take-off, New Rectum Definition

An observational study of Rectal Cancer, run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The diversity of definitions for the rectosigmoid junction is becoming a major obstacle to the standardization of optimal treatment of rectal cancers. The aim of this study was to determine the average height of the sigmoid take-off and its association with individual factors. Read more about this study

Who is it for?
Any age
Conditions the study is for
Rectal Cancer
What is being tested?
Whether to have intestinal-related disease
How many people
835 participants
Where
1 siteChina
Study dates
1 Jun 2019to 1 Feb 2020
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: Patients diagnosed with rectal and sigmoid colon cancer in our center from January 2010 to December 2018 were retrospectively enrolled in the cancer group. The results of 200 controls without colorectal disease were also reviewed (normal group).

Who may be able to join

  • All patients pathologically diagnosed with sigmoid or rectal cancer in Peking University Third Hospital from January 2010 to December 2018 were included in our study as the cancer group. Patients who were found on endoscopy to have cancer more than 20 cm from the anal verge were not included. Patients who received emergency surgery or palliative surgery, patients with a previous history of pelvic surgery, and patients without extractable radiological examinations were also excluded.

Who cannot join

  • Patients who were found on endoscopy to have cancer more than 20 cm from the anal verge were not included.
  • Patients who received emergency surgery or palliative surgery, patients with a previous history of pelvic surgery, and patients without extractable radiological examinations were also excluded.

Trial locations and contacts

1 site in 1 country.

China1 site
  • General Surgery Department, Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

Official title: Comparison Between Different Approaches Applied in the Management of Early Colorectal Cancer: a Bayesian Network Meta-analysis

The diversity of definitions for the rectosigmoid junction is becoming a major obstacle to the standardization of optimal treatment of rectal cancers. The aim of this study was to determine the average height of the sigmoid take-off and its association with individual factors.

Patients diagnosed with rectal and sigmoid colon cancer in our center from January 2010 to December 2018 were retrospectively enrolled in the cancer group. The results of 200 controls without colorectal disease were also reviewed (normal group). The distance of different landmarks and margins of cancer from the anal verge were retrieved from computed tomography (CT), magnetic resonance imaging (MRI), and endoscopy findings.

Read the detailed description

Method Patients All patients pathologically diagnosed with sigmoid or rectal cancer in Peking University Third Hospital from January 2010 to December 2018 were included in our study as the cancer group. Data regarding clinical characteristics and radiological results were retrospectively extracted from the department's database. Patients who were found on endoscopy to have cancer more than 20 cm from the anal verge were not included. Patients who received emergency surgery or palliative surgery, patients with a previous history of pelvic surgery, and patients without extractable radiological examinations were also excluded.

To evaluate the relationship between the height of the sigmoid take-off and all baseline covariates in normal patients, the results of 200 patients without any intestinal-related abnormalities who underwent pelvic MRI in our center from January 2019 to June 2019 were reviewed as a normal group.

Endpoints The sigmoid take-off is the radiological sign representing the transition from mesocolon to mesorectum. It was described as "the point that the surgeon felt there was mobility of the colon away from the vertebral column" . The point of the sigmoid take-off was determined by combining both the sagittal and axial planes in CT and MRI. The distance from the anal verge was measured in sagittal planes by curvilinear distances in accordance with the lumen of the rectum. The distances of the sacral promontory, third sacral segment, and superior and inferior margin of cancers from the anal verge were measured in both CT and MRI following the same standard. The distance of the anterior peritoneal reflection from the anal verge was also measured in MRI. CT and MRI scans were reviewed originally by a junior specialist, and the process of measurement was recorded in the form of photographs. All photographs were then reviewed simultaneously by a senior surgeon and a senior radiologist who were both on colorectal cancer with over fifteen years' experience and were blinded to clinical outcomes and endoscopy results. The data were accepted if both of the senior specialists agreed with the strategy of measurement. If either of the two senior specialists disagreed with the measurement of a certain patient, the strategy of the measurement would be adjusted by the junior specialist until a consensus was reached.

The heights of the superior and inferior margins of the cancers were compared with the heights of various anatomical landmarks in order to classify cancers into different groups according to different definitions of the rectum, and to determine how the distribution of cancers would vary using the different definitions. Both dual classifications (sigmoid colon cancer and rectal cancer) and triple classifications (sigmoid colon cancer, rectosigmoid cancer, and rectal cancer) were applied. In the dual classification, only the distance of the inferior margin of the cancer was compared with the height of certain landmarks. If the distance of the inferior margin was below the height of the landmark, the cancer would be classified as rectal cancer, otherwise, it would be classified as sigmoid colon cancer. In the triple classification, a cancer would be classified as rectal cancer if the height of its superior margin was below the height of the landmark. Rectosigmoid cancer represented cancers straddling the landmark. As in the dual classification, cancers, whose inferior margins were above the height of the landmark were defined as sigmoid colon cancers.

Statistical Analyses Demographic and clinicopathologic data were collected and analyzed in both the cancer group and the normal group. Mean values with standard deviation (SD) or median values with ranges were calculated as appropriate. The influence of factors sex and age on the distance of the sigmoid take-off in the normal group was evaluated by nonparametric statistics and Spearman's correlation analysis, respectively. The distances of the sigmoid take-off as measured in the MRIs of both groups were compared using propensity score matching method. Aside from age and sex, heights of sacral promontory, third sacral segment, and peritoneal reflection were included in constructing the propensity score. A 1:1 matching using both optimal and greedy algorithms without replacement was adopted with a caliper width of 0.1. Differences among results of CT, MRI, and endoscopy in the cancer group were tested using paired T-tests. Both univariate and multivariate linear regression analyses were carried out in both groups to explore the relationship between the height of the sigmoid take-off and individual factors including age, sex and body habitus. Selection of variables entering into the multivariable regression model was based on statistical significance (P< 0.100). All analyses were carried out with IBM SPSS Statistics version 22.0 for Windows. A two-tailed P value less than 0.05 was considered statistically significant.

Conditions
Rectal Cancer
Being tested
Whether to have intestinal-related disease
Keywords
Rectosigmoid junction, sigmoid take-off
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whether to have intestinal-related diseaseDiagnostic test

    All patients pathologically diagnosed with sigmoid or rectal cancer in Peking University Third Hospital from January 2010 to December 2018 were included in our study as the cancer group.To evaluate the relationship between the height of the sigmoid take-off and all baseline covariates in normal patients, the results of 200 patients without any intestinal-related abnormalities who underwent pelvic MRI in our center from January 2019 to June 2019 were reviewed as a normal group.

Study groups in NCT04293835
Study groupRoleWhat they receive
Cancer groupAll patients pathologically diagnosed with sigmoid or rectal cancer in Peking University Third Hospital from January 2010 to December 2018 were included in our study as the cancer group.
Receives: Diagnostic Test: Whether to have intestinal-related disease
Normal group200 patients without any intestinal-related abnormalities who underwent pelvic MRI in our center from January 2019 to June 2019 were reviewed as a normal group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the height of sigmoid take-off

    To evaluate the relationship between the height of the sigmoid take-off and all baseline covariates in normal patients, the results of 200 patients without any intestinal-related abnormalities who underwent pelvic MRI in our center from January 2019 to June 2019 were reviewed as a normal group.The point of the sigmoid take-off was determined by combining both the sagittal and axial planes in CT and MRI. The distance from the anal verge was measured in sagittal planes by curvilinear distances in accordance with the lumen of the rectum.

    Measured: 2010.1 to 2018-12

Secondary outcomes (1)
  1. The distances of the sacral promontory, third sacral segment, and superior, inferior margin of cancers, and anterior peritoneal reflection from the anal verge.

    The distances of the sacral promontory, third sacral segment, and superior and inferior margin of cancers from the anal verge were measured in both CT and MRI following the same standard. The distance of the anterior peritoneal reflection from the anal verge was also measured in MRI.

    Measured: 2010.1 to 2018-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2020
  2. Study start1 Jun 2019
  3. Primary completion1 Dec 2019
  4. Study completion1 Feb 2020

Resources

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
Retrospective
Enrolment
835 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04293835
Sponsor's protocol ID
PekingUTH M2019387
Status last verified
Mar 2020
First submitted
29 Feb 2020
Last updated
4 Mar 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We have uploaded our raw data to Mendeley Data.

Publications

  • D'Souza N, de Neree Tot Babberich MPM, d'Hoore A, Tiret E, Xynos E, Beets-Tan RGH, Nagtegaal ID, Blomqvist L, Holm T, Glimelius B, Lacy A, Cervantes A, Glynne-Jones R, West NP, Perez RO, Quadros C, Lee KY, Madiba TE, Wexner SD, Garcia-Aguilar J, Sahani D, Moran B, Tekkis P, Rutten HJ, Tanis PJ, Wiggers T, Brown G. Definition of the Rectum: An International, Expert-based Delphi Consensus. Ann Surg. 2019 Dec;270(6):955-959. doi: 10.1097/SLA.0000000000003251.

    PubMed 30973385

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Cancer, run by Peking University Third Hospital at 1 site in China.

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 1 inclusion and 2 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 4 Mar 2020. 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 China. 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?

the height of sigmoid take-off (time frame: 2010.1 to 2018-12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04293835, which also lists 1 linked publication.

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 4 Mar 2020.

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