Condition category
Surgery
Date applied
23/10/2010
Date assigned
14/01/2011
Last edited
06/01/2014
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 Roth Beat

ORCID ID

Contact details

Urologische Universitätsklinik
Inselspital
Bern
3010
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

198/10

Study information

Scientific title

Small bowel anastomosis of ileal conduit urinary diversions with the first sewing machine EndoSew™: a prospective single centre non-randomised pilot study

Acronym

Study hypothesis

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

Kantonale Ethikkommission Bern approved on the 11th September 2010 (ref: 198/10)

Study design

Prospective single centre non-randomised pilot study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

Feasibility of a suture by the sewing machine, measured at day 0 (at the time of operation)

Secondary outcome measures

1. Tightness, measured on day 0 (after the suturing), post-operative day 7 and post-operative day 14
2. Operating time, measured at day 0 (at the time of operation)

Overall trial start date

01/12/2010

Overall trial end date

01/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

10 patients (aged greater than 18 years, either sex) scheduled for urinary diversion with an ileal conduit

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/12/2010

Recruitment end date

01/08/2011

Locations

Countries of recruitment

Switzerland

Trial participating centre

Urologische Universitätsklinik
Bern
3010
Switzerland

Sponsor information

Organisation

Inselspital, University Hospital Berne (Switzerland)

Sponsor details

Urology Department (Urologische Universitätsklinik)
Bern
3010
Switzerland

Sponsor type

Hospital/treatment centre

Website

http://www.insel.ch/

Funders

Funder type

Hospital/treatment centre

Funder name

Inselspital, University Hospital Berne (Switzerland) - Department of Urology

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23496430

Publication citations

  1. Results

    Roth B, Birkhäuser FD, Thalmann GN, Zehnder P, Novel prototype sewing device, EndoSew®, for minimally invasive surgery: an extracorporeal ileal conduit construction pilot study in 10 patients., BJU Int., 2013, 112, 7, 959-964, doi: 10.1111/j.1464-410X.2012.11599.x.

Additional files

Editorial Notes