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Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor

Transanal Tube Drainage in Endoscopic Submucosal Dissection of the Colorectal Tumor: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Superiority Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02973490
Enrollment
1200
Registered
2016-11-25
Start date
2017-01-31
Completion date
2021-12-31
Last updated
2016-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Tumor

Keywords

ESD;Transanal Tube Drainage;Colorectal Tumor

Brief summary

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

Detailed 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.

Interventions

DEVICETransanal Tube Drainage

Using transanal tube drainage after colorectal ESD

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative complications30 days post operativelybleeding, perforation,coagulation syndrome

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026