Introduction and Influence of Total Mesorectal Excision (TME) in the Treatment of Rectal Cancer

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00910143
First received: May 28, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 28, 2009
May 28, 2009
January 1993
December 2001   (final data collection date for primary outcome measure)
Local recurrence, recurrence-free survival, overall survival [ Time Frame: 6 months and 1, 2, 3, 4 and 5 years after the operation ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Surgical complications [ Time Frame: first 30 days after the operation ] [ Designated as safety issue: No ]
  • quality of life [ Designated as safety issue: No ]
  • Percentage of patients undergoing transcatheter arterial embolisation [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Introduction and Influence of Total Mesorectal Excision (TME) in the Treatment of Rectal Cancer
Introduction of Total Mesorectal Excision (TME) in the Treatment of Rectal Cancer. Influence of This New Operation Technique on Local Recurrence and Long-Time Survival. Retrospective Study: 1993-2001

Total mesorectal excision (TME) is a rather new operation technique in the treatment of rectal cancer. It is known to reduce the rate of local recurrences. However, the influence on long-term survival is unclear.

Background

The TME technique for rectal cancer surgery was introduced in our department in summer 1995. TME is known to reduce the rate of local recurrences. However, its influence on long-term survival in unclear.

All patients with rectal cancer from 1993 to 2001 are reviewed. The patients charts are reviewed and the following main characteristics are retrieved: age, gender, time of operation, operation technique, tumor stage, tumor localisation, tumor size, neoadjuvant or adjuvant treatment, complications, follow-up with respect to the appearance of local recurrences and distant metastases.

Comparison of two groups of patients. Group 1: patients operated before summer 1995, that is before the introduction of TME. Group 2: patients operated after summer 1995, that is after the introduction of TME.

Objective

Study the influence of a new operation method (TME) on outcome (local recurrence, survival).

Methods

All patients with rectal cancer from 1993 to 2001 are reviewed. The patients charts are reviewed and the following main characteristics are retrieved: age, gender, time of operation, operation technique, tumor stage, tumor localisation, tumor size, neoadjuvant or adjuvant treatment, complications, follow-up with respect to the appearance of local recurrences and distant metastases.

Comparison of two groups of patients. Group 1: patients operated before summer 1995, that is before the introduction of TME. Group 2: patients operated after summer 1995, that is after the introduction of TME.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

all adult patients with adenocarcinoma of the rectum who underwent colorectal surgery at Bern University Hospital between January 1993 and December 2001

Rectal Cancer
  • Procedure: conventional rectal surgery
    type of rectal surgery before the introduction of TME
  • Procedure: total mesorectal excision
    total mesorectal excision
  • 1
    patients operated before summer 1995, that is before the introduction of TME
    Intervention: Procedure: conventional rectal surgery
  • 2
    patients operated after summer 1995, that is after the introduction of TME.
    Intervention: Procedure: total mesorectal excision

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
December 2001
December 2001   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adenocarcinoma of the rectum
  • 16 years and older
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00910143
KEK 08-05-09
No
Pietro Renzulli MD, Bern University Hospital, Departement of visceral Surgery
University Hospital Inselspital, Berne
Not Provided
Principal Investigator: Pietro Renzulli, MD Bern University Hospital, 3010 Bern, Switzerland
University Hospital Inselspital, Berne
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP