Study to compare the clinical outcomes of coiled-end versus straight-end Swan-Neck peritoneal dialysis (PD) catheters
| ISRCTN | ISRCTN05846916 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05846916 |
| Protocol serial number | NCT31143456 |
| Sponsor | Shanghai Ruijin Hospital, Shanghai Jiaotong University, School of Medicine (China) |
| Funders | Leading Academic Discipline Project of Shanghai Health Bureau (China) (05III 001 and 2003ZD002), Shanghai Leading Academic Discipline Project (China) (T0201), The National Natural Science Foundation (China) (81000295) |
- Submission date
- 16/02/2011
- Registration date
- 28/02/2011
- Last edited
- 10/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Nan Chen
Scientific
Scientific
197 Ruijin Er Road
Shanghai
20025
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A prospective, randomised, controlled trial to compare the clinical outcomes of coiled-end versus straight-end Swan-Neck peritoneal dialysis (PD) catheters in Chinese Han population |
| Study objectives | A reliable permanent access is the key factor in the successful delivery of peritoneal dialysis (PD). The main objective of catheter design is to reduce the risk of mechanical and infectious complications. Variations in the design of peritoneal catheters include different numbers of cuffs (single vs double), different shapes of subcutaneous paths (permanently-bent Swan neck catheter vs straight Tenckhoff catheter) and different shapes of intra-abdominal segments (straight vs coiled). A recent systematic review demonstrated that the benefits of various design types have been studied poorly.Most published studies are limited by a small sample size and various design problems, such as lack of stratification by surgeon and presence of several interventions (eg. single vs double cuff, Swan-Neck vs Tenckhoff, Moncrief-Popovich vs conventional insertion technique, median vs lateral insertion site, etc). As a result, the International Society for Peritoneal Dialysis (ISPD) is unable to provide definitive guidelines for catheter choice. Moreover, most studies have been performed in Caucasians, and there is general lack of data relevant to Asian populations. It is generally believed that this design allows for less dialysate inflow pain and less propensity for catheter migration. However, two recent studies have suggested that coiled catheters may be associated with a greater rate of drainage dysfunction due to catheter tip migration and may require replacement more frequently compared to straight catheters. These observations prompted our randomised controlled trial (RCT) with the primary hypothesis that coiled-end catheters may be more prone to catheter tip migration and resultant catheter dysfunction. |
| Ethics approval(s) | Hospital Ethics Committee for Human Research, approved on 14th May 2006, ref no: RJYY200605005 |
| Health condition(s) or problem(s) studied | End stage renal disease requiring renal replacement therapy |
| Intervention | The patients of two groups were randomised to be inserted with a coiled or a straight Swan-neck peritoneal catheter. After the catheter insertion, the twin bag system, lactate dialysate (Dianeal, Baxter, China) with glucose concentration 1.5% or 2.5%, with a dialytic dose of 6-8 L per day was used. |
| Intervention type | Other |
| Primary outcome measure(s) |
Catheter tip migration defined as catheter tip located above the pelvic brim on the abdominal X-ray with associated catheter dysfunction |
| Key secondary outcome measure(s) |
1. All-cause catheter failure (defined by a necessity to remove or reposition the catheter by surgical methods) |
| Completion date | 28/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Age between 18 and 80 2. Presence of end stage renal disease (ESRD) 3. Initiation of Continuous Ambulatory Peritoneal Dialysis (CAPD) therapy in our hospital 4. Expected survival greater than 6 months 5. Provision of informed consent to participate in the study |
| Key exclusion criteria | 1. Unstable or poorly controlled coronary artery disease 2. Severe congestive heart failure (New York Heart Association Grade III or IV) 3. Severe chronic respiratory disease, malignant disease, clinically significant hepatic disease, acute renal failure and psychiatric disease 4. Women who were pregnant or lactating |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 28/02/2008 |
Locations
Countries of recruitment
- China
Study participating centre
197 Ruijin Er Road
Shanghai
20025
China
20025
China
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 | 01/12/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
