Laparoscopy-Assisted Surgery for Carcinoma of the Low Rectum (LASRE)

Fujian Medical University

Status

Unknown

Conditions

Rectal Carcinoma

Treatments

Procedure: conventional open rectal resection

Procedure: laparoscopic-assisted rectal resection

Study type

Interventional

Funder types

Other

Identifiers

NCT01899547

0925-0586

LASRE (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and oncological feasibility of laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.

Enrollment

1,070 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

histologically proven rectal adenocarcinoma
inferior edge of the tumor located within 5 cm from the dentate line as determined by rigid proctoscopy
diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection or extralevator abdominoperineal excision
T3-4a,N0 or T1-4a,N1-2 treated with neoadjuvant chemoradiotherapy
no evidence of distant metastases
tumor size <6cm
sufficient organ function
no contraindication to laparoscopic surgery
without other malignancies in medical history

Exclusion criteria

concurrent or previous diagnosis of invasive cancer within 5 years
locally advanced cancers requiring en bloc multivisceral resection
intestinal obstruction
intestinal perforation
history of colorectal surgery
American Society of Anesthesiologists(ASA) class 4 or 5
pregnant or breast-feeding women
history of mental disorder
participation in another rectal cancer clinical trial relating to surgical technique