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A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler

NCT02565667 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-03-25

No results posted yet for this study

Summary

The most challenge for the surgery of low rectal carcinoma was whether to perform low anterior resection (LAR) and preserve anal function improving the quality of life for patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in reported literature. Up to now, kinds of surgical devices have been employed to reduce anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the problem of "dog ear" phenomena. In the present clinical trial, the investigators use a double purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal resection for low or ultra-low rectal carcinoma, which will resolve the problem of dog ear. The investigators aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.

Conditions

  • Rectal Neoplasms

Interventions

DEVICE

KOL

KOL staple was used for rectal anastomosis

DEVICE

traditional staple

traditional staple was used for rectal anastomosis

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Li Xin-Xiang, M.D & Ph.D. · Shanghai Cancer Center, Fudan University, #270 Dong An Road, Shanghai, 200030

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02565667 on ClinicalTrials.gov