Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor

Fudan University1,200 enrolled

Overview

We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.

Endoscopic submucosal dissection (ESD) is a technique for endoscopic tissue resection that enables endoscopists to control the depth and direction of diathermic knife incisions.Recently, the number of reports in which ESD has been successfully used to treat colorectal tumors has increased. But the complatios with colorectal ESD were higher than esophagus and stomach ESD.We design the clincal trial to investigate the efficacy of transanal tube drainage in colorectal ESD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,200

Conditions

Colorectal Tumor

Interventions

Transanal Tube DrainageDEVICE

Using transanal tube drainage after colorectal ESD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Endoscopy proven colorectal polyp\>2cm, LST\>3cm, SMTs\<2cm Suitable for ESD No other organic disease of colorectal Removing a single lesion one time Informed consent Exclusion Criteria: * Complicated other colorectal diseases, such as,Crohn's disease Familial adenomatous polyposis With previous colorectal surgery Pregnancy or lactation Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III) ESD conversion to laparotomy Patients cannot receive ESD Patients and/or family members can not understand and accept this study

Locations (1)

Endoscopy Center, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

postoperative complications

bleeding, perforation,coagulation syndrome

Time frame: 30 days post operatively

Data from ClinicalTrials.gov

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