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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00810745

Enrollment

Registered

2008-12-18

Start date

2006-01-31

Completion date

2008-11-30

Last updated

2009-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Prolapse

Keywords

ODS, stapled transanal rectal resection

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREstarr

stapled transanal rectal resection

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
incidence of recurrences	2 years

Secondary

Measure	Time frame
outcomes on symptoms and defecography	2 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026