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
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 28, 2009
Last Updated: May 28, 2009
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on July 29, 2014