Introduction and Influence of Total Mesorectal Excision (... | NCT00910143

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

NCT00910143

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

May 29, 2009Estimated

Enrollment

194Actual

Phase

Not provided

Conditions

Rectal Cancer

Interventions

conventional rectal surgery
total mesorectal excision

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1993

Primary Completion Date

Dec 2001Actual

Completion Date

Dec 2001Actual

First Submitted Date

May 28, 2009

First Submission Date that Met QC Criteria

May 28, 2009

First Posted Date

May 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2009

Last Update Posted Date

May 29, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

194Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
conventional rectal surgery	Procedure	type of rectal surgery before the introduction of TME	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local recurrence, recurrence-free survival, overall survival		6 months and 1, 2, 3, 4 and 5 years after the operation

Secondary Outcomes

Measure	Description	Time Frame
Surgical complications		first 30 days after the operation
quality of life
Percentage of patients undergoing transcatheter arterial embolisation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adenocarcinoma of the rectum
16 years and older

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pietro Renzulli, MD	Bern University Hospital, 3010 Bern, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dep. of visceral and transplant surgery, Bern University Hospital		Bern		3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7489148	Background	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.
9448628	Background	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.

ID	Term
D012004	Rectal Neoplasms
D009364	Neoplasm Recurrence, Local

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms