Clinical Trial Summary
Adenoma - carcinoma is a classic pathway of carcinogenesis. On this basis, timely removal of
colon adenomas is a prophylactic measure to prevent colon cancer.
The standard treatment of colorectal adenomas is endoscopic mucosal resection or submucosal
dissection (ESD). In 10 - 15% of cases the ESD is impossible, due to the size of the tumor,
inconvenient localisation in the area of the diverticulum or appendix, the presence of
fibrosis in the submucosal layer (Currie AC framework IDEAL // Colorectal Disease. 2019. No.
9 (21). P. 1004-1016.), (Suzuki S. Short-term results of laparoscopic endoscopic cooperative
surgery of colorectal tumors (LECS-CR) in cases of endoscopically inoperable colorectal
tumors // Surgery today . 2019. No. 12 (49). S. 1051-1057.). In that cases the segmental
colectomy is justified.
An alternative to colectomy is a hybrid laparo-endoscopic surgery, which reduce postoperative
hospital stay, incidence of complications and provide a comparable level of radicality (Lee
SW, Garrett KA, Milsom JW Combined endoscopic and laparoscopic surgery (CELS) // Seminars on
surgery of the colon and rectum. 2017. No. 1 (28). S. 24-29).
Thus, the planned study will contribute to the introduction into practice of an alternative
method of management with tumors of the colon without signs of invasive growth when the
endoscopically removal is impossible.
During the study we will recruit the patients with colon epithelial tumors without signs of
invasive growth which that cannot be removed endoscopically. In case of high risk of
conversion endoscopic procedure the patient will be discussed on MD consillium. All of them
will be informed about the possibility of resection methods in the absence of using
endoscopic technics. Then the patients will be prepared for the operation in accordance with
the method adopted in the clinic. At first colonoscopy will be performed in the operating
room. Those patients for whom to perform endoscopic removal of the formation is impossible
will be randomized intraoperatively using an Internet resource into 2 groups (main and
comparison group).
The patients of the main group will undergo to hybrid laparo-endoscopic operation and
comparative group - to laparoscopic colon resection.
After surgical procedure a pathomorphological examination of the speciments will performed
with assessment of its quality. Postoperative complications in both groups will be recorded
in accordance with the Clavien-Dindo classification. The level of postoperative pain will
also be registred according to the visual analogue pain scale (VAS). Also we will be study
the time of activation of patients, patient self-care scope according to the Bartell scale,
postoperative hospital stay will be assessed.
