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The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis (LaRCIa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05026268
Recruitment Status : Recruiting
First Posted : August 30, 2021
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
State Scientific Centre of Coloproctology, Russian Federation

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: intracorporeal anastomosis Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intracorporeal anastomosis
A laparoscopic right colectomy will be performed according to the surgeons standard practice with the intracorporeal anastomosis performing.
 Procedure: intracorporeal anastomosis
intracorporeal stapled "side-to-side" isoperistaltic anastomosis
No Intervention: extracorporeal anastomosis
A laparoscopic right colectomy will be performed according to the surgeons standard practice.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. The level of postoperative pain [ Time Frame: 0 to 10 days ]
    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).

  2. The time of activation of patients [ Time Frame: 0 to 10 days ]
    We will estimate time to verticalization of patients.

  3. The amount of self-help of patients [ Time Frame: 0 to 10 days ]
    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.

  4. The time to discharge from hospital [ Time Frame: 0 to 30 days ]
    We will count days of postoperativa hospital stay.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age is 18 years and older
  • Patients with right colon cancer
  • Informed agreement

Exclusion Criteria:

  • Carcinomatosis
  • Primary tumor stage T4b
  • Refusal of anastomosis
  • Refusal of the patient to participate in the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05026268


Contacts
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Contact: Sergey Achkasov, MD 89036710225 achkasovy@mail.ru

Locations
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Russian Federation
State Scientific Centre of Coloproctology, Russian Federation Recruiting
Moscow, Russian Federation
Contact: Sergey Achkasov, MD         
Sponsors and Collaborators
State Scientific Centre of Coloproctology, Russian Federation
More Information
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Responsible Party: State Scientific Centre of Coloproctology, Russian Federation
ClinicalTrials.gov Identifier: NCT05026268    
Other Study ID Numbers: 16/21
First Posted: August 30, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by State Scientific Centre of Coloproctology, Russian Federation:
right colon cancer
laparoscopic right colectomy
intracorporeal anastomosis
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases