Prospective randomised trial of laparoscopic versus closed insertion of Tenckhoff catheters for peritoneal dialysis access
| ISRCTN | ISRCTN87054124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87054124 |
| Protocol serial number | N0544093499 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 22/11/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr S Sudhindran
Scientific
Scientific
Box No 210
Transplant Unit
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)7623 851784 |
|---|---|
| sudhindran@bigfoot.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Laparoscopic versus closed insertion of peritoneal dialysis catheters |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Peritoneal dialysis |
| Intervention | Patients who are admitted to Addenbrooke's Hospital for insertion of peritoneal dialysis catheters will be randomised to undergo the procedure by one of the two methods: 1. Percutaneous closed insertion under local anaesthesia in the ward 2. Laparoscopic insertion under general anaesthesia in the main operating theatre The failure rates and complications of the two procedures will be compared. Both these techniques are normally done in this hospital. The only additional requirement from the patient is consent for randomisation. Trial stopped due to poor recruitment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 11/09/2003 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 patients (PROJ) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 11/09/2000 |
| Date of final enrolment | 11/09/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Box No 210
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
