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

NCT04801355 | Unknown

• 1 other identifier: 201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms, Benign

Keywords

Full-thickness laparo-endoscopic; Colorectal tumors; Laparoscopic resection

Outcome Measures

Primary Outcomes (1)

• R1 resection rate

  In according to pathological examination

  30 days

Secondary Outcomes (2)

• The level of postoperative pain

  10 days

• The incidence and structure of postoperative complications

  30 days

Study Arms (2)

laparoscopic resection

OTHER

patients with colonic adenomas who will undergo to laparoscopic segmental resection

Procedure: laparoscopic colon resection

full-thickness laparo-endoscopic colon adenomas excision

EXPERIMENTAL

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

Procedure: full-thickness laparo-endoscopic colon adenomas excision

Interventions

full-thickness laparo-endoscopic colon adenomas excision 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.

full-thickness laparo-endoscopic colon adenomas excision

laparoscopic colon resection PROCEDURE

Standard laparoscopic colon resection

laparoscopic resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Positive regional lymph nodes
• FAP
• The presence of an intestinal stoma
• ASI \> III
• Patients with IBD
• Refusal of the patient to participate in the study

Sponsors & Collaborators

• State Scientific Centre of Coloproctology, Russian Federation: lead

Study Sites (1)

Ryzhikh National Medical Research Center of Coloproctology, Moscow, Russian Federation

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Aleksey Kolosov

  Ryzhikh National Medical Research Center of Coloproctology, Moscow, Russian Federation

  STUDY CHAIR

Central Study Contacts

Sergey Achkasov, professor

CONTACT

+79036710225; achkasovy@mail.ru

Evgenii Surovegin

CONTACT

surovegin.e@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: patients with colon adenomas
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of colorectal surgery and oncology department

Model Details: Laparo-endoscopic full-thickness colon resection

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 17, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)