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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02324556

Acronym

LATA

Enrollment

Registered

2014-12-24

Start date

2015-01-31

Completion date

2015-06-30

Last updated

2020-04-28

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

Conditions

Colorectal Neoplasm

Keywords

Rectal Cancer, Surgery, Laparoscopy

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Number of specimens with grade I specimen according to Quirke	4 weeks postoperatively	Comparison with control group

Secondary

Measure	Time frame
Conversion rate	day of surgery
Re-admission	30 days
Postoperative complications scored according to Clavien-Dindo within the first 12 months	12 months

Countries

Sweden

Outcome results