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

State Scientific Centre of Coloproctology, Russian Federation

Status: Enrolling

Conditions: Colorectal Neoplasms, Benign

Treatments: Procedure: laparoscopic colon resection; Procedure: full-thickness laparo-endoscopic colon adenomas excision

Study type: Interventional

Funder types: Other

Identifiers

NCT04801355

201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients age is 18 years and older
2. Patients with colonic epithelial neoplasms without signs of invasive growth and not removable endoscopically
3. Informed agreement

Exclusion criteria

1. Positive regional lymph nodes
2. FAP
3. The presence of an intestinal stoma
4. ASI > III
5. Patients with IBD
6. Refusal of the patient to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

laparoscopic resection

Other group

Description:

patients with colonic adenomas who will undergo to laparoscopic segmental resection

Treatment:

Procedure: laparoscopic colon resection

full-thickness laparo-endoscopic colon adenomas excision

Experimental group

Description:

patients with colonic adenomas who will undergo to laparo-endoscopic full-thickness colon resection

Treatment:

Procedure: full-thickness laparo-endoscopic colon adenomas excision