A LAparoscopic and TransAnal Total Mesorectal Excision (TME) for Rectal Cancer Trial (LATA)

Sahlgrenska University Hospital

Status

Terminated

Conditions

Colorectal Neoplasm

Study type

Observational

Funder types

Other

Identifiers

NCT02324556

LATA

Details and patient eligibility

About

All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed.

Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.

Full description

The design is comparative and prospective, we will compare specimens from patients operated at our institution during the last year with standard open or laparoscopic approach with patients operated with the new technique. Patients in the control arm will be patients operated prior to the commencement of the new technique or patients not eligible or possible to include in the study.

It is possible to obtain a macroscopically and microscopically adequate specimen after a combined approach with laparoscopic and transanal TME compared to open or laparoscopic conventional TME.

Enrollment

6 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

presenting with a rectal cancer possible to operate with a total mesorectal excision and an anastomosis according to the local multidisciplinary conference
possible to operate with laparoscopic technique
possible to operate in regard to concomitant disease
giving informed consent to participate

Exclusion criteria

-Participation in other trials in conflict with the protocol and end-points the LATA-trial