Contact information
Type
Scientific
Primary contact
Dr Franc Hetzer
ORCID ID
Contact details
Department of Surgery
Cantonal Hospital
Rorschacherstr. 95
St. Gallen
9007
Switzerland
franc.hetzer@kssg.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
012009
Study information
Scientific title
Functional outcome after Perineal Stapled Prolapse resection (PSP) for external rectal prolapse: a prospective observational cohort study
Acronym
PSP
Study hypothesis
Faecal incontinence improves after perineal stapled prolapse resection (PSP).
Ethics approval
Ethics Board of the Canton St. Gallen approved on the 1st December 2007 (ref: EKSG 01/124)
Study design
Prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
External rectal prolapse
Intervention
For the PSP procedure spinal or general anaesthesia is recommended. In lithotripsy positioning the prolapse is completely pulled out and then axially cut open with a linear stapler at three and nine o'clock in lithotomy position. Finally, the prolapse is resected stepwise with the curved Contour® Transtar™ stapler at the prolapse's uptake. Operation duration is about 30 minutes and hospital stay is about 5 days. Peri-operative morbidity is prospectively assessed by a clinical visit at 4 weeks. Functional outcome is measured at 8 weeks by Wexner scores and recurrence rate is assessed by telephone interview at 6 and 12 months after surgery.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Faecal incontinence by Wexner score
2. Constipation by Rome criteria II
3. Urinary bladder dysfunction
Measured 2 months after surgery; recurrence rate is assessed at 6 and 12 months after PSP.
Secondary outcome measures
Post-operative morbidity, collected from 30 days after the intervention.
Overall trial start date
01/12/2007
Overall trial end date
01/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. External rectal prolapse
2. Aged from 18 to 90 years, male and female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
Unfit for surgical intervention
Recruitment start date
01/12/2007
Recruitment end date
01/12/2009
Locations
Countries of recruitment
Switzerland
Trial participating centre
Department of Surgery
St. Gallen
9007
Switzerland
Sponsor information
Organisation
Cantonal Hospital St. Gallen (Switzerland)
Sponsor details
Rorschacherstr. 95
St. Gallen
9007
Switzerland
+41 (0)71 494 1111
franc.hetzer@kssg.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Cantonal Hospital St.Gallen (Switzerland) - covering incidental costs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary