NCT00810745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
Last Updated

February 26, 2009

Status Verified

February 1, 2009

Enrollment Period

2.7 years

First QC Date

December 17, 2008

Last Update Submit

February 25, 2009

Conditions

Rectal Prolapse

Keywords

ODSstapled transanal rectal resection

Outcome Measures

Primary Outcomes (1)

  • incidence of recurrences

    2 years

Secondary Outcomes (1)

  • outcomes on symptoms and defecography

    2 years

Study Arms (1)

rectal resection

EXPERIMENTAL
Procedure: starr

Interventions

starrPROCEDURE

stapled transanal rectal resection

rectal resection

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

First department of general surgery university of milan

Milan, 20122, Italy

Location

First Department of General Surgery

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • paolo boccasanta, md

    1 department of general surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

January 1, 2006

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

February 26, 2009

Record last verified: 2009-02

Locations

IT(2)