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Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor

Fudan University logo

Fudan University

Status

Unknown

Conditions

Colorectal Tumor

Treatments

Device: Transanal Tube Drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT02973490
D2016-11

Details and patient eligibility

About

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

Full description

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.

Enrollment

1,200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,200 participants in 2 patient groups

Transanal Tube Drainage
Experimental group
Description:
patients with transanal tube drainage after ESD
Treatment:
Device: Transanal Tube Drainage
Without Transanal Tube Drainage
No Intervention group
Description:
patients without transanal tube drainage after ESD

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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