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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396928
First Posted: July 19, 2011
Last Update Posted: October 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Universitari de Bellvitge
  Purpose
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.

Condition Intervention Phase
Low Rectal Adenocarcinoma Procedure: Colonic reservoir Phase 2 Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Randomized Study of Two Techniques of Rectal Reservoir in Low Anterior Resection of Rectum

Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Quality of life [ Time Frame: five years ]
    Functional results and quality of life after coloanal anastomosis with colonic reservoir


Secondary Outcome Measures:
  • Morbidity and cost-effectiveness [ Time Frame: 30 days ]
    Investigate if the new technique is more easily, quickly and cheap.


Enrollment: 106
Study Start Date: November 2000
Study Completion Date: July 2010
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
"J" pouch
Anastomosis coloanal wiht "j" pouch reservoir
Procedure: Colonic reservoir
Type of reservoir to be performed
Transverse coloplasty pouch
Coloanal anastomosis with transverse coloplasty pouch reservoir
Procedure: Colonic reservoir
Type of reservoir to be performed

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients wiht low or middle rectal adenocarcinoma after neoadyuvant radio-chemotherapy
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sebastiano Biondo, MD, Barcelona University
ClinicalTrials.gov Identifier: NCT01396928     History of Changes
Other Study ID Numbers: CGD-01/2000
First Submitted: July 18, 2011
First Posted: July 19, 2011
Last Update Posted: October 2, 2012
Last Verified: November 2000

Keywords provided by Hospital Universitari de Bellvitge:
Low rectal adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases