Introduction and Influence of Total Mesorectal Excision (TME) in the Treatment of Rectal Cancer - Full Text View

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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:

Heald RJ. Total mesorectal excision is optimal surgery for rectal cancer: a Scandinavian consensus. Br J Surg. 1995 Oct;82(10):1297-9. No abstract available.

Mella J, Biffin A, Radcliffe AG, Stamatakis JD, Steele RJ. Population-based audit of colorectal cancer management in two UK health regions. Colorectal Cancer Working Group, Royal College of Surgeons of England Clinical Epidemiology and Audit Unit. Br J Surg. 1997 Dec;84(12):1731-6.

Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6.

Maurer CA, Renzulli P, Meyer JD, Büchler MW. [Rectal carcinoma. Optimizing therapy by partial or total mesorectum removal] Zentralbl Chir. 1999;124(5):428-35. Review. German.

Heald RJ, Moran BJ, Ryall RD, Sexton R, MacFarlane JK. Rectal cancer: the Basingstoke experience of total mesorectal excision, 1978-1997. Arch Surg. 1998 Aug;133(8):894-9.

Laurent C, Nobili S, Rullier A, Vendrely V, Saric J, Rullier E. Efforts to improve local control in rectal cancer compromise survival by the potential morbidity of optimal mesorectal excision. J Am Coll Surg. 2006 Nov;203(5):684-91. Epub 2006 Sep 20.

Kapiteijn E, Putter H, van de Velde CJ; Cooperative investigators of the Dutch ColoRectal Cancer Group. Impact of the introduction and training of total mesorectal excision on recurrence and survival in rectal cancer in The Netherlands. Br J Surg. 2002 Sep;89(9):1142-9.

Bernardshaw SV, Øvrebø K, Eide GE, Skarstein A, Røkke O. Treatment of rectal cancer: reduction of local recurrence after the introduction of TME - experience from one University Hospital. Dig Surg. 2006;23(1-2):51-9. Epub 2006 May 23.

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 June 18, 2013