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Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum

NCT ID: NCT01396928

Last Updated: 2012-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-11-30

Study Completion Date

2010-07-31

Brief Summary

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The aim of the study CGD-01/2000 was to investigate wheter a transverse coloplasty pouch is able to improve functional results and quality of life after coloanal anastomosis.

Detailed Description

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Conditions

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Low Rectal Adenocarcinoma

Keywords

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Low rectal adenocarcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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"J" pouch

Anastomosis coloanal wiht "j" pouch reservoir

Colonic reservoir

Intervention Type PROCEDURE

Type of reservoir to be performed

Transverse coloplasty pouch

Coloanal anastomosis with transverse coloplasty pouch reservoir

Colonic reservoir

Intervention Type PROCEDURE

Type of reservoir to be performed

Interventions

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Colonic reservoir

Type of reservoir to be performed

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Low or middle rectal adenocarcinoma without involvement of the anal sphincter
* Neoadjuvant chemoradiotherapy
* Age older than 18 years
* Wexner index of less than 5
* Signed informed consent

Exclusion Criteria

* Involvement of the anal sphincter
* Wexner index of 5 or more
* Declined informed consent
* Psychological or social problems
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

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Barcelona University

References

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Biondo S, Frago R, Codina Cazador A, Farres R, Olivet F, Golda T, Miguel B, Kreisler E. Long-term functional results from a randomized clinical study of transverse coloplasty compared with colon J-pouch after low anterior resection for rectal cancer. Surgery. 2013 Mar;153(3):383-92. doi: 10.1016/j.surg.2012.08.012. Epub 2012 Sep 14.

Reference Type DERIVED
PMID: 22981362 (View on PubMed)

Other Identifiers

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CGD-01/2000

Identifier Type: -

Identifier Source: org_study_id