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

Terminated

• Conditions: Colorectal Neoplasm

• Registration Number: NCT02324556
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study First Submitted: 2014-11-27
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-24
• Study Start: 2015-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-26
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of specimens with grade I specimen according to Quirke	4 weeks postoperatively	Comparison with control group

Secondary Outcome Measures

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

Trial Locations

Locations (2)

NU-sjukvården; 🇸🇪 Trollhattan, Sweden

Dept. of Surgery, Sahlgrenska University Hospital/Ostra; 🇸🇪 Gothenburg, Sweden