Sigmoid NeoplasmsNCT03774134
Five Year Oncological Outcome After CME for Sigmoid Colon Cancer
An observational study of Sigmoid Neoplasms, run by Nordsjaellands Hospital.
Trial summary
Study based in existing databases investigating the causal oncological treatment effects of complete mesocolic excision on UICC stage I-III sigmoid colon cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sigmoid Neoplasms
- What is being tested?
- Complete mesocolic excision and Conventional colon resection
- Type of treatment
- Surgery or procedure
- How many people
- 920 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2008to 31 Dec 2025
- 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: Data for all patients undergoing elective surgery for UICC stage I-III colonic adenocarcinoma in the Capital Region of Denmark. The population of this region is approximately 1⋅75 million, more than 30 per cent of the population of Denmark, and it is served by only four public university colorectal cancer centres.
Who may be able to join
- Sigmoid colon cancer was defined as primary adenocarcinomas located in the sigmoid colon (more than 15 cm from the anal verge)
- UICC stage I-III
Who cannot join
- Synchronous colorectal cancer - even in the sigmoid colon
- No residual tumor in the specimen after neoadjuvant chemotherapy
- Metachronous colorectal cancer
- Resections in Hillerød not performed according to the principles of CME
- Non-macroradical (R2) resections (peroperative assessment)
About this study
Official title: Five Year Oncological Outcome After Complete Mesocolic Excision for Sigmoid Colon Cancer: a Population-based Cohort Study
Study based in existing databases investigating the causal oncological treatment effects of complete mesocolic excision on UICC stage I-III sigmoid colon cancer
Read the detailed description
Population-based cohort study, predominantly prospective based, on the same population as our previously study comparing short-term outcome after CME with conventional colon resections. The COMES database combines the prospectively registered colon cancer database in Hillerød (CME data), and data from the national database of the Danish Colorectal Cancer Group (DCCG) covering patients undergoing conventional resection (non-CME) in the other three centers. The medical records of all the patients in the non-CME group (control group) were reviewed by colorectal surgeons from Hillerød. Data audit for all CME patients was performed by various co-authors employed at the other centers. A similar audit of data for non-CME patients having postoperative complications or recurrence was performed by the co-author representing the department treating the specific patients. Follow-up data were registered prospectively in the medical records of the participating departments during patient follow-up.
Continuous data are presented as median and interquartile ranges, and categorical data as frequencies and proportions. Kruskal-Wallis test and Fisher's exact test were used as appropriate. Death is a competing risk to recurrence and time-to-event analyses were performed as competing risk analyses obtaining the cumulative incidences for recurrence or death using the "cmprsk" R-package.
Unbiased estimation of marginal or population-averaged treatment effects in observational and non-randomized studies can be obtained through different propensity score methods. Inverse Probability of Treatment Weighting (IPTW) uses the propensity score to weight each patient's data based on the inverse probability of receiving the treatment actually received. IPTW gives unbiased estimates of average treatment effects in time-to-event analyses if no differences in observed baseline covariates exist between the treatment groups. To account for baseline differences between patients in the two groups, stabilized weights truncated at the 0.99 interval were calculated using the "IPW" R-package. The following baseline covariates will be used: age, sex, ASA score, neoadjuvant chemotherapy, tumor morphology, perineural invasion, extramural venous invasion, tumor stage, and serosal invasion. All covariates used and UICC stage, two-way interactions, and squared terms of continuous covariates will be assessed for balance between the CME and the non-CME group after IPTW using the "cobalt" R-package. Absolute mean differences in mean (using standardized mean difference) and proportions (using raw mean difference) below 0.1, and variance ratios between 0.5 and 2 will be accepted. Graphical inspection of the distribution of covariates will be also performed.
The cause-specific hazards and overall survival will be analyzed using Cox regression. Binary outcomes were analyzed using logistic regression. Lymph node yield will be analyzed using linear regression after logarithmic transformation. Number of metastatic lymph nodes will be analyzed using negative binominal regression. All analyses of primary and secondary outcomes will be performed after IPTW. The 95% confidence intervals for the estimates from the original Cox regression IPTW analyses will be constructed after 1000 bootstraps with replacement, and a robust sandwich estimator will be used for the logistic regression analyses in order to ensure correct variance estimation.
All available data will be used. Model assumptions will be checked. A p-value below or equal to 0.05 will be considered significant. All analyses will be performed using R statistical software, version 3.5.1 (R Foundation for Statistical Computing, Vienna, Austria).
- Conditions
- Sigmoid Neoplasms
- Being tested
- Complete mesocolic excision, Conventional colon resection
- Keywords
- Colon cancer, Surgery, Oncological outcome, Survival
- Medical subject headings
- Sigmoid Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete mesocolic excisionProcedure or surgery
Based on the principles of CME. The inferior mesenteric artery (IMA) was divided at its origin from the aorta to perform central lymph nodes dissection along the IMA between the aorta and the branching of the left colic artery. Sigmoid resection included the complete sigmoid colon and resection of the upper part of the rectum to ensure sufficient perfusion of the colo-rectal anastomosis. To achieve sufficient distance at the proximal bowel resection margin, parts of the descending colon or even left hemicolectomy were performed at the surgeon's discretion.
Conventional colon resectionProcedure or surgery
The patients underwent what was considered standard colon cancer resections in Denmark during the study period.
| Study group | Role | What they receive |
|---|---|---|
| CME group | The CME group consisted of patients, who underwent elective CME for sigmoid colon adenocarcinoma at Nordsjaellands Hospital Hillerød from 1 June 2008 to 31 December 2014. Receives: Procedure: Complete mesocolic excision | |
| Non-CME group | The non-CME group comprised patients having a elective conventional colon cancer resection for sigmoid adenocarcinoma at the other three colorectal centers in the Capital Region of Denmark from 1 June 2008 to 31 December 2013. Receives: Procedure: Conventional colon resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of recurrence
Recurrence diagnosed by CT or positron emission tomography (PET)/CT of thorax and abdomen, chest radiograph and contrast-enhanced ultrasound of the liver, or laparotomy in case of suspicion of recurrence. Histological
- Page 4 of 6 - verification of radiological findings of metastases during follow-up is not needed if the local multidisciplinary team conference deemed the finding as a recurrence. Metachronous colon tumors diagnosed during follow-up are considered as recurrences only if located in the anastomosis and with the same morphology as the primary tumor.
Measured: 5.2 years
Secondary outcomes (4)
Overall survival
Death by any cause
Measured: 5.2 years
Short-term mortality
Death from any cause within 30 and 90 days
Measured: 30 and 90 days
Rate of postoperative complications
Patients having surgical and non-surgical postoperative complications and with complications with Clavien-Dindo score of 3b or more
Measured: 60 days
Mesocolic lymph nodes yield
Median number of lymph nodes detected in the specimens and proportion of specimens with 22 or more lymph nodes detected
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start1 Jun 2008
- Primary completion31 Jan 2019
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sigmoid NeoplasmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, Herlev Hospital, Hvidovre University Hospital, Zealand University Hospital
- Responsible party
- Sponsor
- Investigators
- Claus A Bertelsen, PhD, MD, Study chair, Department of Surgery, Nordsjaellands Hospital Hillerød
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774134
- Sponsor's protocol ID
- CMELoS2019
- Status last verified
- Jun 2024
- First submitted
- 10 Dec 2018
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenberg J, Fischer A, Haglind E; Scandinavian Surgical Outcomes Research Group. Current controversies in colorectal surgery: the way to resolve uncertainty and move forward. Colorectal Dis. 2012 Mar;14(3):266-9. doi: 10.1111/j.1463-1318.2011.02896.x.
PubMed 22122825West NP, Sutton KM, Ingeholm P, Hagemann-Madsen RH, Hohenberger W, Quirke P. Improving the quality of colon cancer surgery through a surgical education program. Dis Colon Rectum. 2010 Dec;53(12):1594-603. doi: 10.1007/DCR.0b013e3181f433e3.
PubMed 21178852Hohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5.
PubMed 19016817Bokey L, Chapuis PH, Chan C, Stewart P, Rickard MJ, Keshava A, Dent OF. Long-term results following an anatomically based surgical technique for resection of colon cancer: a comparison with results from complete mesocolic excision. Colorectal Dis. 2016 Jul;18(7):676-83. doi: 10.1111/codi.13159.
PubMed 26476136Bertelsen CA, Neuenschwander AU, Jansen JE, Wilhelmsen M, Kirkegaard-Klitbo A, Tenma JR, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Iversen ER, Kristensen B, Gogenur I; Danish Colorectal Cancer Group. Disease-free survival after complete mesocolic excision compared with conventional colon cancer surgery: a retrospective, population-based study. Lancet Oncol. 2015 Feb;16(2):161-8. doi: 10.1016/S1470-2045(14)71168-4. Epub 2014 Dec 31.
PubMed 25555421Kotake K, Mizuguchi T, Moritani K, Wada O, Ozawa H, Oki I, Sugihara K. Impact of D3 lymph node dissection on survival for patients with T3 and T4 colon cancer. Int J Colorectal Dis. 2014 Jul;29(7):847-52. doi: 10.1007/s00384-014-1885-z. Epub 2014 May 6.
PubMed 24798631Olofsson F, Buchwald P, Elmstahl S, Syk I. High Tie or not in Resection for Cancer in the Sigmoid Colon? Scand J Surg. 2019 Sep;108(3):227-232. doi: 10.1177/1457496918812198. Epub 2018 Nov 21.
PubMed 30458672Bertelsen CA, Neuenschwander AU, Jansen JE, Kirkegaard-Klitbo A, Tenma JR, Wilhelmsen M, Rasmussen LA, Jepsen LV, Kristensen B, Gogenur I; Copenhagen Complete Mesocolic Excision Study (COMES); Danish Colorectal Cancer Group (DCCG). Short-term outcomes after complete mesocolic excision compared with 'conventional' colonic cancer surgery. Br J Surg. 2016 Apr;103(5):581-9. doi: 10.1002/bjs.10083. Epub 2016 Jan 18.
PubMed 26780563Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
PubMed 21818162Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015 Dec 10;34(28):3661-79. doi: 10.1002/sim.6607. Epub 2015 Aug 3.
PubMed 26238958
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Year Oncological Outcome After Complete Mesocolic Excision for Sigmoid Colon Cancer: a Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT03774134
- Acronym / sponsor ID
- CMELoS2019
- Conditions
- Sigmoid Neoplasms
- Keywords
- Colon cancer, Surgery, Oncological outcome, Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 920 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, Herlev Hospital, Hvidovre University Hospital, Zealand University Hospital
- Study start
- 1 Jun 2008 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Dec 2018 (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.
Study based in existing databases investigating the causal oncological treatment effects of complete mesocolic excision on UICC stage I-III sigmoid colon cancer
Detailed description
Population-based cohort study, predominantly prospective based, on the same population as our previously study comparing short-term outcome after CME with conventional colon resections. The COMES database combines the prospectively registered colon cancer database in Hillerød (CME data), and data from the national database of the Danish Colorectal Cancer Group (DCCG) covering patients undergoing conventional resection (non-CME) in the other three centers. The medical records of all the patients in the non-CME group (control group) were reviewed by colorectal surgeons from Hillerød. Data audit for all CME patients was performed by various co-authors employed at the other centers. A similar audit of data for non-CME patients having postoperative complications or recurrence was performed by the co-author representing the department treating the specific patients. Follow-up data were registered prospectively in the medical records of the participating departments during patient follow-up.
Continuous data are presented as median and interquartile ranges, and categorical data as frequencies and proportions. Kruskal-Wallis test and Fisher's exact test were used as appropriate. Death is a competing risk to recurrence and time-to-event analyses were performed as competing risk analyses obtaining the cumulative incidences for recurrence or death using the "cmprsk" R-package.
Unbiased estimation of marginal or population-averaged treatment effects in observational and non-randomized studies can be obtained through different propensity score methods. Inverse Probability of Treatment Weighting (IPTW) uses the propensity score to weight each patient's data based on the inverse probability of receiving the treatment actually received. IPTW gives unbiased estimates of average treatment effects in time-to-event analyses if no differences in observed baseline covariates exist between the treatment groups. To account for baseline differences between patients in the two groups, stabilized weights truncated at the 0.99 interval were calculated using the "IPW" R-package. The following baseline covariates will be used: age, sex, ASA score, neoadjuvant chemotherapy, tumor morphology, perineural invasion, extramural venous invasion, tumor stage, and serosal invasion. All covariates used and UICC stage, two-way interactions, and squared terms of continuous covariates will be assessed for balance between the CME and the non-CME group after IPTW using the "cobalt" R-package. Absolute mean differences in mean (using standardized mean difference) and proportions (using raw mean difference) below 0.1, and variance ratios between 0.5 and 2 will be accepted. Graphical inspection of the distribution of covariates will be also performed.
The cause-specific hazards and overall survival will be analyzed using Cox regression. Binary outcomes were analyzed using logistic regression. Lymph node yield will be analyzed using linear regression after logarithmic transformation. Number of metastatic lymph nodes will be analyzed using negative binominal regression. All analyses of primary and secondary outcomes will be performed after IPTW. The 95% confidence intervals for the estimates from the original Cox regression IPTW analyses will be constructed after 1000 bootstraps with replacement, and a robust sandwich estimator will be used for the logistic regression analyses in order to ensure correct variance estimation.
All available data will be used. Model assumptions will be checked. A p-value below or equal to 0.05 will be considered significant. All analyses will be performed using R statistical software, version 3.5.1 (R Foundation for Statistical Computing, Vienna, Austria).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CME group | – | Procedure: Complete mesocolic excisionThe CME group consisted of patients, who underwent elective CME for sigmoid colon adenocarcinoma at Nordsjaellands Hospital Hillerød from 1 June 2008 to 31 December 2014. |
| Non-CME group | – | Procedure: Conventional colon resectionThe non-CME group comprised patients having a elective conventional colon cancer resection for sigmoid adenocarcinoma at the other three colorectal centers in the Capital Region of Denmark from 1 June 2008 to 31 December 2013. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data for all patients undergoing elective surgery for UICC stage I-III colonic adenocarcinoma in the Capital Region of Denmark. The population of this region is approximately 1⋅75 million, more than 30 per cent of the population of Denmark, and it is served by only four public university colorectal cancer centres.
Key inclusion criteria (2 listed)
- Sigmoid colon cancer was defined as primary adenocarcinomas located in the sigmoid colon (more than 15 cm from the anal verge)
- UICC stage I-III
Key exclusion criteria (5 listed)
- Synchronous colorectal cancer - even in the sigmoid colon
- No residual tumor in the specimen after neoadjuvant chemotherapy
- Metachronous colorectal cancer
- Resections in Hillerød not performed according to the principles of CME
- Non-macroradical (R2) resections (peroperative assessment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete mesocolic excisionBased on the principles of CME. The inferior mesenteric artery (IMA) was divided at its origin from the aorta to perform central lymph nodes dissection along the IMA between the aorta and the branching of the left colic artery. Sigmoid resection included the complete sigmoid colon and resection of the upper part of the rectum to ensure sufficient perfusion of the colo-rectal anastomosis. To achieve sufficient distance at the proximal bowel resection margin, parts of the descending colon or even left hemicolectomy were performed at the surgeon's discretion. | Procedure or surgery | CME group |
| Conventional colon resectionThe patients underwent what was considered standard colon cancer resections in Denmark during the study period. | Procedure or surgery | Non-CME group |
Primary outcome
Risk of recurrence
Time frame: 5.2 years
Recurrence diagnosed by CT or positron emission tomography (PET)/CT of thorax and abdomen, chest radiograph and contrast-enhanced ultrasound of the liver, or laparotomy in case of suspicion of recurrence. Histological - Page 4 of 6 - verification of radiological findings of metastases during follow-up is not needed if the local multidisciplinary team conference deemed the finding as a recurrence. Metachronous colon tumors diagnosed during follow-up are considered as recurrences only if located in the anastomosis and with the same morphology as the primary tumor.
4 secondary outcomes
Overall survival
Time frame: 5.2 years
Short-term mortality
Time frame: 30 and 90 days
Rate of postoperative complications
Time frame: 60 days
Mesocolic lymph nodes yield
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 22122825Rosenberg J, Fischer A, Haglind E; Scandinavian Surgical Outcomes Research Group. Current controversies in colorectal surgery: the way to resolve uncertainty and move forward. Colorectal Dis. 2012 Mar;14(3):266-9. doi: 10.1111/j.1463-1318.2011.02896.x.
- Background: PubMed 21178852West NP, Sutton KM, Ingeholm P, Hagemann-Madsen RH, Hohenberger W, Quirke P. Improving the quality of colon cancer surgery through a surgical education program. Dis Colon Rectum. 2010 Dec;53(12):1594-603. doi: 10.1007/DCR.0b013e3181f433e3.
- Background: PubMed 19016817Hohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5.
- Background: PubMed 26476136Bokey L, Chapuis PH, Chan C, Stewart P, Rickard MJ, Keshava A, Dent OF. Long-term results following an anatomically based surgical technique for resection of colon cancer: a comparison with results from complete mesocolic excision. Colorectal Dis. 2016 Jul;18(7):676-83. doi: 10.1111/codi.13159.
- Background: PubMed 25555421Bertelsen CA, Neuenschwander AU, Jansen JE, Wilhelmsen M, Kirkegaard-Klitbo A, Tenma JR, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Iversen ER, Kristensen B, Gogenur I; Danish Colorectal Cancer Group. Disease-free survival after complete mesocolic excision compared with conventional colon cancer surgery: a retrospective, population-based study. Lancet Oncol. 2015 Feb;16(2):161-8. doi: 10.1016/S1470-2045(14)71168-4. Epub 2014 Dec 31.
- Background: PubMed 24798631Kotake K, Mizuguchi T, Moritani K, Wada O, Ozawa H, Oki I, Sugihara K. Impact of D3 lymph node dissection on survival for patients with T3 and T4 colon cancer. Int J Colorectal Dis. 2014 Jul;29(7):847-52. doi: 10.1007/s00384-014-1885-z. Epub 2014 May 6.
- Background: PubMed 30458672Olofsson F, Buchwald P, Elmstahl S, Syk I. High Tie or not in Resection for Cancer in the Sigmoid Colon? Scand J Surg. 2019 Sep;108(3):227-232. doi: 10.1177/1457496918812198. Epub 2018 Nov 21.
- Background: PubMed 26780563Bertelsen CA, Neuenschwander AU, Jansen JE, Kirkegaard-Klitbo A, Tenma JR, Wilhelmsen M, Rasmussen LA, Jepsen LV, Kristensen B, Gogenur I; Copenhagen Complete Mesocolic Excision Study (COMES); Danish Colorectal Cancer Group (DCCG). Short-term outcomes after complete mesocolic excision compared with 'conventional' colonic cancer surgery. Br J Surg. 2016 Apr;103(5):581-9. doi: 10.1002/bjs.10083. Epub 2016 Jan 18.
- Background: PubMed 21818162Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
- Background: PubMed 26238958Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015 Dec 10;34(28):3661-79. doi: 10.1002/sim.6607. Epub 2015 Aug 3.
- Individual participant dataSharing planned: No
Related trials for Sigmoid Neoplasms
Recruiting
Comparison of Safety and Efficacy of Detaenial Sigmoid Neobladder and Ileal Neobladder
Bladder Cancer, Urinary Diversion
Recruiting
Comparison Capsule Sparing Cystectomy and Radical Cystoprostatectomy in Men With Bladder Cancer
Bladder Cancer
RecruitingObservational study
The Supraspinal Control of Lower Urinary Tract Function in Patients With Orthotopic Sigmoid Neobladder.
Orthotopic Neobladder
Enrolling by invitation
Disposable Intestinal Isolation and Protection Device for Patients With Rectal and Lower Sigmoid Colon Tumors Undergoing Laparoscopic AR/LAR Surgery
Disposable Intestinal Isolation and Protection Device
Recruiting
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
Colorectal Anastomosis, Left-sided Colon Resection
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.
Claus A Bertelsen, PhD, MD study chair
Department of Surgery, Nordsjaellands Hospital Hillerød
Questions about this trial
What is this clinical trial studying?
An observational study of Sigmoid Neoplasms, run by Nordsjaellands Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Risk of recurrence (time frame: 5.2 years). 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 NCT03774134, which also lists 10 linked publications.
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 26 Jun 2024.