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

NCT02324556 | Terminated

• 1 other identifier: LATA
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Neoplasm

Keywords

Rectal Cancer; Surgery; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Number of specimens with grade I specimen according to Quirke

  Comparison with control group

  4 weeks postoperatively

Secondary Outcomes (3)

• Conversion rate

  day of surgery

• Re-admission

  30 days

• Postoperative complications scored according to Clavien-Dindo within the first 12 months

  12 months

Study Arms (2)

Laparoscopic total mesorectal excision

Patients operated with laparoscopic total mesorectal surgery for rectal cancer

transanal total mesorectal excision

Patients operated with a combined transanal and laparosocopic total mesorectal surgery for rectal cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rectal cancer possible to operate with an anterior resection.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (2)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

Location

NU-sjukvården

Trollhättan, Sweden

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Eva Angenete, M.D., Ph.D.

  Sahlgrenska Universitetssjukhuset/Östra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant Surgeon, Associate professor

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 24, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

SE (2)