Functional outcome after Perineal Stapled Prolapse resection (PSP) for external rectal prolapse
| ISRCTN | ISRCTN68491191 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68491191 |
| Protocol serial number | 012009 |
| Sponsor | Cantonal Hospital St. Gallen (Switzerland) |
| Funder | Cantonal Hospital St.Gallen (Switzerland) - covering incidental costs |
- 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
Scientific
Department of Surgery
Cantonal Hospital
Rorschacherstr. 95
St. Gallen
9007
Switzerland
| franc.hetzer@kssg.ch |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) |
1. Faecal incontinence by Wexner score |
| Key secondary outcome measure(s) |
Post-operative morbidity, collected from 30 days after the intervention. |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | All |
| Target sample size at registration | 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
9007
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
