Rectal CancerNCT00910143
Introduction and Influence of Total Mesorectal Excision (TME) in the Treatment of Rectal Cancer
An observational study of Rectal Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- conventional rectal surgery and total mesorectal excision
- Type of treatment
- Surgery or procedure
- How many people
- 194 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 1993to Dec 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all adult patients with adenocarcinoma of the rectum who underwent colorectal surgery at Bern University Hospital between January 1993 and December 2001
Who may be able to join
- adenocarcinoma of the rectum
- 16 years and older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of visceral and transplant surgery, Bern University Hospital
Bern, 3010
About this study
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
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.
- Conditions
- Rectal Cancer
- Being tested
- conventional rectal surgery, total mesorectal excision
- Keywords
- Rectal cancer, Colorectal Surgery, Surgery, Local neoplasm recurrence, survival, Follow-up Study
- Medical subject headings
- Rectal Neoplasms, Neoplasm Recurrence, Local
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional rectal surgeryProcedure or surgery
type of rectal surgery before the introduction of TME
total mesorectal excisionProcedure or surgery
total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients operated before summer 1995, that is before the introduction of TME Receives: Procedure: conventional rectal surgery | |
| 2 | patients operated after summer 1995, that is after the introduction of TME. Receives: Procedure: total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence, recurrence-free survival, overall survival
Measured: 6 months and 1, 2, 3, 4 and 5 years after the operation
Secondary outcomes (3)
Surgical complications
Measured: first 30 days after the operation
quality of life
Percentage of patients undergoing transcatheter arterial embolisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startJan 1993
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Pietro Renzulli, MD, Principal investigator, Bern University Hospital, 3010 Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910143
- Sponsor's protocol ID
- KEK 08-05-09
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- No
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 7489148Mella 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 9448628Heald 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 6751457Maurer 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 10420530Heald 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 9711965Laurent 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 17084330Kapiteijn 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 12190680Bernardshaw 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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00910143
- Acronym / sponsor ID
- KEK 08-05-09
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Colorectal Surgery, Surgery, Local neoplasm recurrence, survival, Follow-up Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 1993
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 29 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: conventional rectal surgerypatients operated before summer 1995, that is before the introduction of TME |
| 2 | – | Procedure: total mesorectal excisionpatients operated after summer 1995, that is after the introduction of TME. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all adult patients with adenocarcinoma of the rectum who underwent colorectal surgery at Bern University Hospital between January 1993 and December 2001
Key inclusion criteria (2 listed)
- adenocarcinoma of the rectum
- 16 years and older
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional rectal surgerytype of rectal surgery before the introduction of TME | Procedure or surgery | 1 |
| total mesorectal excisiontotal mesorectal excision | Procedure or surgery | 2 |
Primary outcome
Local recurrence, recurrence-free survival, overall survival
Time frame: 6 months and 1, 2, 3, 4 and 5 years after the operation
3 secondary outcomes
Surgical complications
Time frame: first 30 days after the operation
quality of life
Percentage of patients undergoing transcatheter arterial embolisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
- Background: PubMed 7489148Heald 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.
- Background: PubMed 9448628Mella 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.
- Background: PubMed 6751457Heald 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.
- Background: PubMed 10420530Maurer 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.
- Background: PubMed 9711965Heald 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.
- Background: PubMed 17084330Laurent 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.
- Background: PubMed 12190680Kapiteijn 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.
- Background: PubMed 16717469Bernardshaw 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Renzulli, MD principal investigator
Bern University Hospital, 3010 Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence, recurrence-free survival, overall survival (time frame: 6 months and 1, 2, 3, 4 and 5 years after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00910143, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2009.