Functional outcome after Perineal Stapled Prolapse resection (PSP) for external rectal prolapse

ISRCTN ISRCTN68491191
DOI https://doi.org/10.1186/ISRCTN68491191
Secondary identifying numbers 012009
Submission date
10/06/2009
Registration date
30/06/2009
Last edited
23/10/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Franc Hetzer
Scientific

Department of Surgery
Cantonal Hospital
Rorschacherstr. 95
St. Gallen
9007
Switzerland

Email franc.hetzer@kssg.ch

Study information

Study designProspective observational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleFunctional outcome after Perineal Stapled Prolapse resection (PSP) for external rectal prolapse: a prospective observational cohort study
Study acronymPSP
Study objectivesFaecal incontinence improves after perineal stapled prolapse resection (PSP).
Ethics approval(s)Ethics Board of the Canton St. Gallen approved on the 1st December 2007 (ref: EKSG 01/124)
Health condition(s) or problem(s) studiedExternal rectal prolapse
InterventionFor 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 typeOther
Primary outcome measure1. 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 measuresPost-operative morbidity, collected from 30 days after the intervention.
Overall study start date01/12/2007
Completion date01/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit90 Years
SexBoth
Target number of participants50
Total final enrolment32
Key inclusion criteria1. External rectal prolapse
2. Aged from 18 to 90 years, male and female
Key exclusion criteriaUnfit for surgical intervention
Date of first enrolment01/12/2007
Date of final enrolment01/12/2009

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Department of Surgery
St. Gallen
9007
Switzerland

Sponsor information

Cantonal Hospital St. Gallen (Switzerland)
Hospital/treatment centre

Rorschacherstr. 95
St. Gallen
9007
Switzerland

Phone +41 (0)71 494 1111
Email franc.hetzer@kssg.ch
ROR logo "ROR" https://ror.org/00gpmb873

Funders

Funder type

Hospital/treatment centre

Cantonal Hospital St.Gallen (Switzerland) - covering incidental costs

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 08/03/2010 23/10/2020 Yes No

Editorial Notes

The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.