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

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: conventional rectal surgery; Procedure: total mesorectal excision

• Registration Number: NCT00910143
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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.

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.

Study Timeline

• Study Start: 1993-01
• Primary Completion: 2001-12
• Study Completion: 2001-12
• Status Verified: 2009-05
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Last Update Submitted: 2009-05-28
• Study First Posted: 2009-05-29
• Last Update Posted: 2009-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

• adenocarcinoma of the rectum
• 16 years and older

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	conventional rectal surgery	patients operated before summer 1995, that is before the introduction of TME
2	total mesorectal excision	patients operated after summer 1995, that is after the introduction of TME.

Primary Outcome Measures

Name	Time	Method
Local recurrence, recurrence-free survival, overall survival	6 months and 1, 2, 3, 4 and 5 years after the operation

Secondary Outcome Measures

Name	Time	Method
Surgical complications	first 30 days after the operation
quality of life
Percentage of patients undergoing transcatheter arterial embolisation

Trial Locations

Locations (1)

Dep. of visceral and transplant surgery, Bern University Hospital; 🇨🇭 Bern, Switzerland