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OpenTrials
Completed

NCT Number: NCT01396928

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

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.

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Key information

Conditions

Low Rectal Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colonic reservoir

Procedure

Type of reservoir to be performed

Primary outcomes

  1. Quality of life

    Time frame: five years

    Functional results and quality of life after coloanal anastomosis with colonic reservoir

Secondary outcomes

  1. Morbidity and cost-effectiveness

    Time frame: 30 days

    Investigate if the new technique is more easily, quickly and cheap.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2005
Study completion
2010
First posted
Jul 19, 2011
Registry last updated
Oct 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.