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NCT Number: NCT00910143

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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Recurrence, Local Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of visceral and transplant surgery, Bern University Hospital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adenocarcinoma of the rectum
  • 16 years and older

Treatment and study plan

conventional rectal surgery

Procedure

type of rectal surgery before the introduction of TME

Total mesorectal excision

Procedure

total mesorectal excision

Primary outcomes

  1. Local recurrence, recurrence-free survival, overall survival

    Time frame: 6 months and 1, 2, 3, 4 and 5 years after the operation

Secondary outcomes

  1. Surgical complications

    Time frame: first 30 days after the operation

  2. quality of life

  3. Percentage of patients undergoing transcatheter arterial embolisation

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study 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

Important dates

Study start
1993
Primary completion
2001
Study completion
2001
First posted
May 29, 2009
Registry last updated
May 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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