Skip to main content
OpenTrials
Completed

NCT Number: NCT00810745

What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?

This randomized study was designed to compare the 2 year clinical and functional results with the STARR procedure using a new curved cutter stapler or the same operation done with 2 traditional circular staplers.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rectal Prolapse Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

First Department of General Surgery, Milan, Italy

Loading trial locations.

About this study

From January to November 2006, 80 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography and randomly assigned to 2 groups: 40 patients underwent stapled transanal rectal resection with two staplers PPH-01 (Ethicon Endosurgery Inc, Pomezia, Italy) (STARR group) and 40 had the same operation with new, curved multi-fire stapler Contour R Transtar TM (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and perineography.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Rectal prolapse
  • Rectocele
  • ODS score > 15
  • Continence score < 3
  • Resting pressure > 40 mm/Hg

Exclusion criteria

  • Previous anorectal surgery
  • Ods score < 15
  • Continence score > 3
  • Resting pressure < 40
  • Concomitant pelvic floor diseases
  • Psychiatric diseases
  • Absolute contraindications to surgery

Treatment and study plan

starr

Procedure

stapled transanal rectal resection

Primary outcomes

  1. incidence of recurrences

    Time frame: 2 years

Secondary outcomes

  1. outcomes on symptoms and defecography

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation? Two-Year Outcomes From a Randomized Controlled Trial

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 18, 2008
Registry last updated
Feb 26, 2009

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.