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

University of Milan

Status and phase: Completed; Phase 4

Conditions: Rectal Prolapse

Treatments: Procedure: starr

Study type: Interventional

Funder types: Other

Identifiers

NCT00810745

starr

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 1 patient group

rectal resection

Experimental group

Treatment:

Procedure: starr