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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Neoplasms, Benign

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Laparo-endoscopic full-thickness colon resection

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

patients with colon adenomas

Study Groups

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laparoscopic resection

patients with colonic adenomas who will undergo to laparoscopic segmental resection

Group Type OTHER

laparoscopic colon resection

Intervention Type PROCEDURE

Standard laparoscopic colon resection

full-thickness laparo-endoscopic colon adenomas excision

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

Group Type EXPERIMENTAL

full-thickness laparo-endoscopic colon adenomas excision

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

laparoscopic colon resection

Standard laparoscopic colon resection

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No