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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01396928
First received: July 18, 2011
Last updated: October 1, 2012
Last verified: November 2000
  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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

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


Secondary Outcome Measures:
  • Morbidity and cost-effectiveness [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Hospital Universitari de Bellvitge

Additional 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
Study First Received: July 18, 2011
Last Updated: October 1, 2012
Health Authority: Spain: Hospital Universitari de Bellvitge

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

ClinicalTrials.gov processed this record on September 11, 2014