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Full-thickness Laparo-endoscopic Excision vs Laparoscopic Colectomy for Colonic Tumors

NCT04801355 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-25

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms, Benign

Interventions

PROCEDURE

full-thickness laparo-endoscopic colon adenomas excision

Full-thickness laparo-endoscopic removal of colon adenomas will be performed as follows: an endoscopist during intraoperative colonoscopy visualize the neoplasm, intra-luminary marks the margins of resection and stop at this in some cases. In another one: endoscopist start full-thickness removal of this lesion then the abdominal team during laparoscopy, with using laparoscopic technique, performe full-thickness resection of intestine wall with the tumor. Speciment extracted intralumenary or via minilaparotomy. Defect of the intestinal wall is sutured intracorporeally using laparoscopic technic. Desuflation, suturing of trocar sites.

PROCEDURE

laparoscopic colon resection

Standard laparoscopic colon resection

Sponsors & Collaborators

  • State Scientific Centre of Coloproctology, Russian Federation

    lead OTHER_GOV

Principal Investigators

  • Aleksey Kolosov · Ryzhikh National Medical Research Center of Coloproctology, Moscow, Russian Federation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-12-01
Completion
2023-04-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04801355 on ClinicalTrials.gov