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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910143
• Other study ID #: KEK 08-05-09
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: May 28, 2009
• Start date: January 1993
• Est. completion date: December 2001

Study information

• Verified date: May 2009
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• adenocarcinoma of the rectum

• 16 years and older

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• conventional rectal surgery
type of rectal surgery before the introduction of TME
• total mesorectal excision
total mesorectal excision

Locations

Country	Name	City	State
Switzerland	Dep. of visceral and transplant surgery, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

Heald RJ. Total mesorectal excision is optimal surgery for rectal cancer: a Scandinavian consensus. Br J Surg. 1995 Oct;82(10):1297-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence, recurrence-free survival, overall survival		6 months and 1, 2, 3, 4 and 5 years after the operation	No
Secondary	Surgical complications		first 30 days after the operation	No
Secondary	quality of life			No
Secondary	Percentage of patients undergoing transcatheter arterial embolisation			No