The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
LaRCIa
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedAugust 30, 2021
August 1, 2021
1.9 years
August 6, 2021
August 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
0 to 30 days
Secondary Outcomes (4)
The level of postoperative pain
0 to 10 days
The time of activation of patients
0 to 10 days
The amount of self-help of patients
0 to 10 days
The time to discharge from hospital
0 to 30 days
Study Arms (2)
Intracorporeal anastomosis
EXPERIMENTALA laparoscopic right colectomy will be performed according to the surgeons standard practice with the intracorporeal anastomosis performing.
extracorporeal anastomosis
NO INTERVENTIONA laparoscopic right colectomy will be performed according to the surgeons standard practice.
Interventions
intracorporeal stapled "side-to-side" isoperistaltic anastomosis
Eligibility Criteria
You may qualify if:
- Patients age is 18 years and older
- Patients with right colon cancer
- Informed agreement
You may not qualify if:
- Carcinomatosis
- Primary tumor stage T4b
- Refusal of anastomosis
- Refusal of the patient to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Scientific Centre of Coloproctology, Russian Federation
Moscow, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2021
First Posted
August 30, 2021
Study Start
September 1, 2021
Primary Completion
August 1, 2023
Study Completion
August 1, 2023
Last Updated
August 30, 2021
Record last verified: 2021-08