Colon CancerLaRCIaNCT05026268
The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
A study testing intracorporeal anastomosis in people with Colon Cancer, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
This is a randomized, controlled, "non-inferiority" trial to determine the non-difference in post-operative complications rate in laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis formation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- intracorporeal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2021to Aug 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patients age is 18 years and older
- Patients with right colon cancer
- Informed agreement
Who cannot join
- Carcinomatosis
- Primary tumor stage T4b
- Refusal of anastomosis
- Refusal of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Scientific Centre of Coloproctology, Russian Federation
Moscow
Sergey Achkasov, MD
About this study
This is a randomized, controlled, "non-inferiority" trial to determine the non-difference in post-operative complications rate in laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis formation.
Read the detailed description
The design involves random allocation of eligible patients to laparosopic colectomy with intracorporeal or extracorporeal anastomosis.
Postoperative complications in both groups will be recorded in accordance with the Clavien-Dindo classification. The level of postoperative pain will be registred according to the visual analogue pain scale (VAS). Also the investigators will study the time of activation of patients, patient self-care scope according to the Bartell scale, postoperative hospital stay will be assessed.
- Conditions
- Colon Cancer
- Being tested
- intracorporeal anastomosis
- Keywords
- right colon cancer, laparoscopic right colectomy, intracorporeal anastomosis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracorporeal anastomosisProcedure or surgery
intracorporeal stapled "side-to-side" isoperistaltic anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal anastomosis | Experimental | A laparoscopic right colectomy will be performed according to the surgeons standard practice with the intracorporeal anastomosis performing. Receives: Procedure: intracorporeal anastomosis |
| extracorporeal anastomosis | No intervention | A laparoscopic right colectomy will be performed according to the surgeons standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications rate
The incidence and structure of postoperative complications according to the Clavien-Dindo scale (I-grade - any deviation from the normal course of the postoperative course without the need for pharmacological, surgical, endoscopic or interventional radiological interventions. drugs that are acceptable include antiemetics, antipyretics, analgesics, diuretics, and electrolytes. In addition, this grade includes a wound infection "stopped at the patient's bedside", V grades - Death of the patient).
Measured: 0 to 30 days
Secondary outcomes (4)
The level of postoperative pain
The level of postoperative pain with using a visual analogue pain scale: The patient assesses the postoperative pain from 0 to 10 points (0 points - no pain, 10 - unbearable pain).
Measured: 0 to 10 days
The time of activation of patients
We will estimate time to verticalization of patients.
Measured: 0 to 10 days
The amount of self-help of patients
We will estimate the amount of self-help of patients on the Bartel scale. Total score - 100. Indicators from 0 to 20 points correspond to complete dependence, from 21 to 60 points - severe dependence, from 61 to 90 points - moderate, from 91 to 99 life points - light dependence in everyday life.
Measured: 0 to 10 days
The time to discharge from hospital
We will count days of postoperativa hospital stay.
Measured: 0 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026268
- Sponsor's protocol ID
- 16/21
- Acronym
- LaRCIa
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 30 Aug 2021
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
- ClinicalTrials.gov ID
- NCT05026268
- Acronym / sponsor ID
- LaRCIa / 16/21
- Conditions
- Colon Cancer
- Keywords
- right colon cancer, laparoscopic right colectomy, intracorporeal anastomosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- Sep 2021 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 30 Aug 2021 (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.
This is a randomized, controlled, "non-inferiority" trial to determine the non-difference in post-operative complications rate in laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis formation.
Detailed description
The design involves random allocation of eligible patients to laparosopic colectomy with intracorporeal or extracorporeal anastomosis.
Postoperative complications in both groups will be recorded in accordance with the Clavien-Dindo classification. The level of postoperative pain will be registred according to the visual analogue pain scale (VAS). Also the investigators will study the time of activation of patients, patient self-care scope according to the Bartell scale, postoperative hospital stay will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal anastomosis | Experimental | Procedure: intracorporeal anastomosisA laparoscopic right colectomy will be performed according to the surgeons standard practice with the intracorporeal anastomosis performing. |
| extracorporeal anastomosis | No intervention | –A laparoscopic right colectomy will be performed according to the surgeons standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age is 18 years and older
- Patients with right colon cancer
- Informed agreement
Key exclusion criteria (4 listed)
- Carcinomatosis
- Primary tumor stage T4b
- Refusal of anastomosis
- Refusal of the patient to participate in the study
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 |
|---|---|---|
| intracorporeal anastomosisintracorporeal stapled "side-to-side" isoperistaltic anastomosis | Procedure or surgery | Intracorporeal anastomosis |
Primary outcome
Post-operative complications rate
Time frame: 0 to 30 days
The incidence and structure of postoperative complications according to the Clavien-Dindo scale (I-grade - any deviation from the normal course of the postoperative course without the need for pharmacological, surgical, endoscopic or interventional radiological interventions. drugs that are acceptable include antiemetics, antipyretics, analgesics, diuretics, and electrolytes. In addition, this grade includes a wound infection "stopped at the patient's bedside", V grades - Death of the patient).
4 secondary outcomes
The level of postoperative pain
Time frame: 0 to 10 days
The time of activation of patients
Time frame: 0 to 10 days
The amount of self-help of patients
Time frame: 0 to 10 days
The time to discharge from hospital
Time frame: 0 to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracorporeal anastomosis in people with Colon Cancer, run by State Scientific Centre of Coloproctology, Russian Federation 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 4 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 30 Aug 2021. 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 Sergey Achkasov, MD (89036710225, achkasovy@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications rate (time frame: 0 to 30 days). 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 30 Aug 2021.