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

Colorectal Neoplasm Clinical Trial

— LATA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02324556
• Other study ID #: LATA
• Status: Terminated
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: April 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms
• Rectal Neoplasms

Locations

Country	Name	City	State
Sweden	Dept. of Surgery, Sahlgrenska University Hospital/Ostra	Gothenburg
Sweden	NU-sjukvården	Trollhattan

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of specimens with grade I specimen according to Quirke	Comparison with control group	4 weeks postoperatively
Secondary	Conversion rate		day of surgery
Secondary	Re-admission		30 days
Secondary	Postoperative complications scored according to Clavien-Dindo within the first 12 months		12 months