Colon Cancer
Conditions
Keywords
right colon cancer, laparoscopic right colectomy, intracorporeal anastomosis
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.
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.
Interventions
PROCEDUREintracorporeal anastomosis
intracorporeal stapled side-to-side isoperistaltic anastomosis
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative complications rate | 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
| Measure | Time frame | Description |
|---|---|---|
| The time of activation of patients | 0 to 10 days | We will estimate time to verticalization of patients. |
| The level of postoperative pain | 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). |
| The amount of self-help of patients | 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. |
| The time to discharge from hospital | 0 to 30 days | We will count days of postoperativa hospital stay. |
Countries
Russia
Contacts
Primary ContactSergey Achkasov, MD
Outcome results
None listed