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 design	Prospective observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Functional outcome after Perineal Stapled Prolapse resection (PSP) for external rectal prolapse: a prospective observational cohort study
Study acronym	PSP
Study objectives	Faecal 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) studied	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
Primary outcome measure	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 study start date	01/12/2007
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	90 Years
Sex	Both
Target number of participants	50
Total final enrolment	32
Key inclusion criteria	1. External rectal prolapse 2. Aged from 18 to 90 years, male and female
Key exclusion criteria	Unfit for surgical intervention
Date of first enrolment	01/12/2007
Date of final enrolment	01/12/2009

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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.