Condition category
Digestive System
Date applied
10/06/2009
Date assigned
30/06/2009
Last edited
30/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes