Small bowel anastomosis of ileal conduit urinary diversions with the first sewing machine EndoSew™
| ISRCTN | ISRCTN65809197 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65809197 |
| Protocol serial number | 198/10 |
| Sponsor | Inselspital, University Hospital Berne (Switzerland) |
| Funder | Inselspital, University Hospital Berne (Switzerland) - Department of Urology |
- Submission date
- 23/10/2010
- Registration date
- 14/01/2011
- Last edited
- 06/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Roth Beat
Scientific
Scientific
Urologische Universitätsklinik
Inselspital
Bern
3010
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective single centre non-randomised pilot study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Small bowel anastomosis of ileal conduit urinary diversions with the first sewing machine EndoSew™: a prospective single centre non-randomised pilot study |
| Study objectives | The small bowel (ileal) anastomosis of urinary diversions is performed by hand sutures in most centres. We test the first sewing machine EndoSew™ in a prospective single centre pilot trial. The aim is to prove feasibility of an open tight anastomosis by the sewing machine which - in the future - can be adopted in laparoscopic cystectomies and urinary diversions. |
| Ethics approval(s) | Kantonale Ethikkommission Bern approved on the 11th September 2010 (ref: 198/10) |
| Health condition(s) or problem(s) studied | Small bowel anastomosis |
| Intervention | Urinary diversion is performed by the sewing machine EndoSew™ in an open approach. Thightness of the suture is tested intra-operatively as well as 7 and 14 days post-operatively by loopogramms. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Feasibility of a suture by the sewing machine, measured at day 0 (at the time of operation) |
| Key secondary outcome measure(s) |
1. Tightness, measured on day 0 (after the suturing), post-operative day 7 and post-operative day 14 |
| Completion date | 01/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Key inclusion criteria | 10 patients (aged greater than 18 years, either sex) scheduled for urinary diversion with an ileal conduit |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 01/08/2011 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Urologische Universitätsklinik
Bern
3010
Switzerland
3010
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 | 01/11/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
