Colorectal CancerNCT06050447
Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
An observational study of Colorectal Cancer and Colon Cancer, run by Immanuel Kant Baltic Federal University at 1 site in Russia.
Trial summary
The study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colon Cancer, Rectal Cancer
- What is being tested?
- Right hemicolectomy, Left hemicolectomy and Sigmoid colon resection
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2023to 1 Sep 2026
- How long will I take part?
- 3 Years
- 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: An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up
Who may be able to join
- Histologically proven primary adenocarcinoma of bowel;
- All patients who have indications for surgical treatment of colorectal cancer based on the decision of the oncological council;
- Signed informed consent with agreement to attend all study visits;
Who cannot join
- Unresectable tumor or contradictions to surgery;
- Indications for chemotherapy or radiation therapy prior to surgery;
- Patient withdrawal from the trial or loss of follow-up;
- Emergent operation;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Baltic Federal University
Kaliningrad, Kaliningrad Oblast, 236041
Viktor V Kakotkin, MD, +74012595071, Vkakotkin@kantiana.ru
Mikhail A Agapov, PhD/MD
About this study
The study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.
- Conditions
- Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Adenocarcinoma, Colorectal Neoplasms Malignant, Rectal Adenocarcinoma
- Being tested
- Right hemicolectomy, Left hemicolectomy, Sigmoid colon resection, Anterior resection of the rectum, Low anterior resection of the rectum
- Keywords
- Colorectal cancer, Rectal cancer, Colon cancer, Colorectal surgery, anastomotic leakage, postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Anastomotic Leak, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right hemicolectomyProcedure or surgery
Resection of the caecum and ascending colon is appropriate for patients with tumors located anywhere from caecum to the transverse colon
Left hemicolectomyProcedure or surgery
Resection of the sigmoid colon is appropriate for patients with tumors located anywhere from the distal transverse colon to the rectosigmoid junction.
Sigmoid colon resectionProcedure or surgery
Resection of the sigmoid colon is appropriate for patients with tumors located in the sigmoid colon
Anterior resection of the rectumProcedure or surgery
AR is appropriate for tumors located in rectosigmoid junction and in the proximal rectum
Low anterior resection of the rectumProcedure or surgery
LAR is appropriate for tumors located in the middle and low rectum
Abdominoperineal resectionProcedure or surgery
APR is appropriate for distal rectal cancers that invade the external sphincter or the levator muscles
Total ColectomyProcedure or surgery
Total abdominal colectomy may be indicated for patients with primary multiple cancer tumors
| Study group | Role | What they receive |
|---|---|---|
| Patients with right-sided colon cancer | Tumors located anywhere from the cecum to the proximal transverse colon. Receives: Procedure: Right hemicolectomy | |
| Patients with left-sided colon cancer | Tumors located anywhere from the distal transverse colon to the rectosigmoid junction Receives: Procedure: Left hemicolectomy; Procedure: Sigmoid colon resection | |
| Patients with rectal cancer | Tumors located in rectosigmoid junction and in the rectum with/without the external sphincter or the levator muscles invasion Receives: Procedure: Anterior resection of the rectum; Procedure: Low anterior resection of the rectum; Procedure: Abdominoperineal resection | |
| Patients with right- and left-sided colon cancer (primary multiple cancer) | Patients with primary multiple cancer tumors Receives: Procedure: Total Colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage rate
Anastomotic leakage rate after colorectal resection.
AL is confirmed by one or more of the following conditions:
- fecal discharge from the pelvic drainage at any time after surgery
- rectovaginal fistula defined as fecal or mucus discharge from the vagina
- pelvic sepsis as defined by the collection of pus/ fecal material in the pelvis documented by CT scan
- contrast present outside of the anastomosis as seen by X-Ray contrast enema proctography or CT contrast enema proctography
Measured: 3 months after surgery
Mortality rate
the overall mortality after colorectal cancer surgery
Measured: 3 years after surgery
Secondary outcomes (4)
30-day complication rate
The number of patients with complications after colorectal resection. All complications will be assessed according to the Clavien-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V).
Grade I - Any deviation from the normal postoperative course without the need for treatment.
Grade II - Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Grade III - Requiring surgical, endoscopic or radiological intervention
- IIIa - Intervention not under general anesthesia
- IIIb - Intervention under general anesthesia Grade IV - Life-threatening complication requiring IC/ICU-management
- IVa - single organ dysfunction (including dialysis)
- IVb - multiorgandysfunction Grade V - Death of a patient
Measured: 30 days after surgery
Recurrence rate
All cases of colorectal cancer recurrence
Measured: 3 years after surgery
Cancer-specific survival
The number of patients survived within 3 years after the diagnosis
Measured: 3 years after surgery
Recurrence-free survival
The number of patients without cancer recurrence within 3 years after surgery
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 1,200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Immanuel Kant Baltic Federal University
- Sponsor type
- University, hospital or other
- Collaborators
- Center of Endourology "Endocenter"
- Responsible party
- Sponsor
- Investigators
- Mikhail A Agapov, PhD, Principal investigator, Baltic Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050447
- Sponsor's protocol ID
- 5995465480
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 22 Sep 2023
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06050447
- Acronym / sponsor ID
- 5995465480
- Conditions
- Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Adenocarcinoma, Colorectal Neoplasms Malignant, Rectal Adenocarcinoma
- Keywords
- Colorectal cancer, Rectal cancer, Colon cancer, Colorectal surgery, anastomotic leakage, postoperative complications, recurrence rate, cancer-specific survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Immanuel Kant Baltic Federal UniversityUniversity, hospital or other
- Collaborators
- Center of Endourology "Endocenter"
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Sep 2023 (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 study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with right-sided colon cancer | – | Procedure: Right hemicolectomyTumors located anywhere from the cecum to the proximal transverse colon. |
| Patients with left-sided colon cancer | – | Procedure: Left hemicolectomy, Procedure: Sigmoid colon resectionTumors located anywhere from the distal transverse colon to the rectosigmoid junction |
| Patients with rectal cancer | – | Procedure: Anterior resection of the rectum, Procedure: Low anterior resection of the rectum, Procedure: Abdominoperineal resectionTumors located in rectosigmoid junction and in the rectum with/without the external sphincter or the levator muscles invasion |
| Patients with right- and left-sided colon cancer (primary multiple cancer) | – | Procedure: Total ColectomyPatients with primary multiple cancer tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up
Key inclusion criteria (3 listed)
- Histologically proven primary adenocarcinoma of bowel;
- All patients who have indications for surgical treatment of colorectal cancer based on the decision of the oncological council;
- Signed informed consent with agreement to attend all study visits;
Key exclusion criteria (5 listed)
- Unresectable tumor or contradictions to surgery;
- Indications for chemotherapy or radiation therapy prior to surgery;
- Patient withdrawal from the trial or loss of follow-up;
- Emergent operation;
- Pregnancy.
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 |
|---|---|---|
| Right hemicolectomyResection of the caecum and ascending colon is appropriate for patients with tumors located anywhere from caecum to the transverse colon | Procedure or surgery | Patients with right-sided colon cancer |
| Left hemicolectomyResection of the sigmoid colon is appropriate for patients with tumors located anywhere from the distal transverse colon to the rectosigmoid junction. | Procedure or surgery | Patients with left-sided colon cancer |
| Sigmoid colon resectionResection of the sigmoid colon is appropriate for patients with tumors located in the sigmoid colon | Procedure or surgery | Patients with left-sided colon cancer |
| Anterior resection of the rectumAR is appropriate for tumors located in rectosigmoid junction and in the proximal rectum | Procedure or surgery | Patients with rectal cancer |
| Low anterior resection of the rectumLAR is appropriate for tumors located in the middle and low rectum | Procedure or surgery | Patients with rectal cancer |
| Abdominoperineal resectionAPR is appropriate for distal rectal cancers that invade the external sphincter or the levator muscles | Procedure or surgery | Patients with rectal cancer |
| Total ColectomyTotal abdominal colectomy may be indicated for patients with primary multiple cancer tumors | Procedure or surgery | Patients with right- and left-sided colon cancer (primary multiple cancer) |
Primary outcome
Anastomotic leakage rate
Time frame: 3 months after surgery
Anastomotic leakage rate after colorectal resection. AL is confirmed by one or more of the following conditions: * fecal discharge from the pelvic drainage at any time after surgery * rectovaginal fistula defined as fecal or mucus discharge from the vagina * pelvic sepsis as defined by the collection of pus/ fecal material in the pelvis documented by CT scan * contrast present outside of the anastomosis as seen by X-Ray contrast enema proctography or CT contrast enema proctography
Mortality rate
Time frame: 3 years after surgery
the overall mortality after colorectal cancer surgery
4 secondary outcomes
30-day complication rate
Time frame: 30 days after surgery
Recurrence rate
Time frame: 3 years after surgery
Cancer-specific survival
Time frame: 3 years after surgery
Recurrence-free survival
Time frame: 3 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- 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.
Mikhail A Agapov, PhD principal investigator
Baltic Federal University
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 Colorectal Cancer and Colon Cancer, run by Immanuel Kant Baltic Federal University at 1 site in Russia.
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 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 22 Sep 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana N Garmanova, PhD (+79773429249, tatianagarmanova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage rate (time frame: 3 months after 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 22 Sep 2023.