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CompletedNCT00910143Updated May 29, 2009

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

An observational study in Rectal Cancer, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2009-05-29.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
194
Ages
16 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Rectal Cancer

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Keywords

  • Rectal cancer
  • Colorectal Surgery
  • Surgery
  • Local neoplasm recurrence
  • survival
  • Follow-up Study
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In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 194 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
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

Eligibility criteria

Inclusion Criteria:

  • adenocarcinoma of the rectum
  • 16 years and older
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
194 participants (actual)

Groups and cohorts

  • 1

    patients operated before summer 1995, that is before the introduction of TME

    Procedure: conventional rectal surgery

  • 2

    patients operated after summer 1995, that is after the introduction of TME.

    Procedure: total mesorectal excision

Interventions

  • Procedureconventional rectal surgery

    type of rectal surgery before the introduction of TME

  • Proceduretotal mesorectal excision

    total mesorectal excision

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What researchers measure

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

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Study locations

1 site
  • Dep. of visceral and transplant surgery, Bern University Hospital
    Bern, 3010, Switzerland
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References and documents

Publications

  • Heald RJ. Total mesorectal excision is optimal surgery for rectal cancer: a Scandinavian consensus. Br J Surg. 1995 Oct;82(10):1297-9. doi: 10.1002/bjs.1800821002. No abstract available. PubMed 7489148 ↗
  • 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. PubMed 9448628 ↗
  • 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. doi: 10.1002/bjs.1800691019. PubMed 6751457 ↗
  • Maurer CA, Renzulli P, Meyer JD, Buchler MW. [Rectal carcinoma. Optimizing therapy by partial or total mesorectum removal]. Zentralbl Chir. 1999;124(5):428-35. German. PubMed 10420530 ↗
  • 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. doi: 10.1001/archsurg.133.8.894. PubMed 9711965 ↗
  • 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. doi: 10.1016/j.jamcollsurg.2006.07.021. Epub 2006 Sep 20. PubMed 17084330 ↗
  • 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. doi: 10.1046/j.1365-2168.2002.02196.x. PubMed 12190680 ↗
  • Bernardshaw SV, Ovrebo K, Eide GE, Skarstein A, Rokke 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. doi: 10.1159/000093494. Epub 2006 May 23. PubMed 16717469 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00910143
Lead sponsor
Insel Gruppe AG, University Hospital Bern
First posted
May 29, 2009
Start date
Jan 1993
Primary completion
Dec 2001
Completion
Dec 2001
Last update
May 29, 2009

Study contacts

Pietro Renzulli, MD
principal investigator · Bern University Hospital, 3010 Bern, Switzerland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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