Clinical trial NCT04801355: Full-thickness Laparo-endoscopic Excision vs Laparoscopic Colectomy for Colonic Tumors
Official title: Single-center, Randomized Trial: Full-thickness Laparo-endoscopic Excision vs Laparoscopic Colectomy for Colonic Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms, Benign
Keywords: Full-thickness laparo-endoscopic
Colorectal tumors
Laparoscopic resection
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2021-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Laparo-endoscopic full-thickness colon resection
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: R1 resection rate
timeFrame: 30 days
Secondary outcomes:
measure: The level of postoperative pain
timeFrame: 10 days
measure: The incidence and structure of postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Ryzhikh National Medical Research Center of Coloproctology, Moscow, Russian Federation
Study officials:
affiliation: Ryzhikh National Medical Research Center of Coloproctology, Moscow, Russian Federation
name: Aleksey Kolosov
role: STUDY_CHAIR
References: