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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910143
First Posted: May 29, 2009
Last Update Posted: May 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Inselspital, Berne
  Purpose
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.

Condition Intervention
Rectal Cancer Procedure: conventional rectal surgery Procedure: total mesorectal excision

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Local recurrence, recurrence-free survival, overall survival [ Time Frame: 6 months and 1, 2, 3, 4 and 5 years after the operation ]

Secondary Outcome Measures:
  • Surgical complications [ Time Frame: first 30 days after the operation ]
  • quality of life
  • Percentage of patients undergoing transcatheter arterial embolisation

Enrollment: 194
Study Start Date: January 1993
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
patients operated before summer 1995, that is before the introduction of TME
Procedure: conventional rectal surgery
type of rectal surgery before the introduction of TME
2
patients operated after summer 1995, that is after the introduction of TME.
Procedure: total mesorectal excision
total mesorectal excision

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all adult patients with adenocarcinoma of the rectum who underwent colorectal surgery at Bern University Hospital between January 1993 and December 2001
Criteria

Inclusion Criteria:

  • adenocarcinoma of the rectum
  • 16 years and older
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910143


Locations
Switzerland
Dep. of visceral and transplant surgery, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Pietro Renzulli, MD Bern University Hospital, 3010 Bern, Switzerland
  More Information

Publications:

Responsible Party: Pietro Renzulli MD, Bern University Hospital, Departement of visceral Surgery
ClinicalTrials.gov Identifier: NCT00910143     History of Changes
Other Study ID Numbers: KEK 08-05-09
First Submitted: May 28, 2009
First Posted: May 29, 2009
Last Update Posted: May 29, 2009
Last Verified: May 2009

Keywords provided by University Hospital Inselspital, Berne:
Rectal cancer
Colorectal Surgery
Surgery
Local neoplasm recurrence
survival
Follow-up Study

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases