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

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Terminated
CT.gov ID
NCT02324556
Collaborator
(none)
6
Enrollment
2
Locations
5
Duration (Months)
3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    6 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    A LAparoscopic and TransAnal Total Mesorectal Excision (TME for Rectal Cancer Trial
    Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Jun 1, 2015
    Actual Study Completion Date :
    Jun 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Number of specimens with grade I specimen according to Quirke [4 weeks postoperatively]

      Comparison with control group

    Secondary Outcome Measures

    1. Conversion rate [day of surgery]

    2. Re-admission [30 days]

    3. Postoperative complications scored according to Clavien-Dindo within the first 12 months [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Surgery, Sahlgrenska University Hospital/Ostra Gothenburg Sweden SE 416 85
    2 NU-sjukvården Trollhattan Sweden

    Sponsors and Collaborators

    • Sahlgrenska University Hospital, Sweden

    Investigators

    • Principal Investigator: Eva Angenete, M.D., Ph.D., Sahlgrenska Universitetssjukhuset/Östra

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eva Angenete, Senior Consultant Surgeon, Associate professor, Sahlgrenska University Hospital, Sweden
    ClinicalTrials.gov Identifier:
    NCT02324556
    Other Study ID Numbers:
    • LATA
    First Posted:
    Dec 24, 2014
    Last Update Posted:
    Apr 28, 2020
    Last Verified:
    Apr 1, 2020
    Keywords provided by Eva Angenete, Senior Consultant Surgeon, Associate professor, Sahlgrenska University Hospital, Sweden
    Rectal Cancer
    Surgery
    Laparoscopy
    Additional relevant MeSH terms:
    Rectal Neoplasms
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Apr 28, 2020