Conventional open versus laparoscopic surgery for peritoneal dialysis (PD) peritonitis
| ISRCTN | ISRCTN55802603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55802603 |
| Protocol serial number | UHL 10636 |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Funders | University Hospitals of Leicester NHS Trust (UK), University of Leicester (UK) |
- Submission date
- 19/10/2009
- Registration date
- 30/11/2009
- Last edited
- 02/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Transplant Group
University Hospitals of Leicester
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled single-centre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial of conventional open versus laparoscopic surgery for peritoneal dialysis (PD) peritonitis |
| Study objectives | Peritoneal dialysis (PD) may be complicated by the development of peritonitis and this problem has an incidence of approximately 1.5 episodes per patient in year one. All patients with PD peritonitis are all admitted under the care of the nephrology team and the vast majority are treated by conservative measures. This involves the administration of intraperitoneal (IP) antibiotics in a large single dose of vancomycin and oral ciprofloxacin. Some patients are also given intravenous (IV) antibiotics, chosen according to the results of microbiological analysis of the infected PD fluid. In certain circumstances these patient require surgery to treat this infection. The trial has been designed to test the safety and efficacy of the laparoscopic operation in comparison with the traditional open procedure. The primary outcome measure will be post-operative pain levels and analgesic requirements. |
| Ethics approval(s) | Leicestershire, Northamptonshire and Rutland Research Ethics Committee 2, 30/01/2009, ref: 08/H0402/132 |
| Health condition(s) or problem(s) studied | Peritoneal dialysis (PD) peritonitis |
| Intervention | Laparoscopic versus conventional open PD catheter removal and peritoneal lavage for PD peritonitis. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Post-operative pain levels and analgesic requirements. The following outcome data are collected: |
| Key secondary outcome measure(s) |
Return to normal activities and post-operative respiratory function. |
| Completion date | 10/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Any patient (both males and females) 18 years or over presenting with PD peritonitis requiring surgery referred by a nephrologist to the surgical team as defined below: 1.1. Failure of the medical treatment described above i.e. refractory peritonitis. In these cases the use of appropriate IP/IVantibiotics fails to improve the patient's clinical condition (pain and abdominal tenderness) and the turbid effluent PD fluid doesn't become clear, suggesting that infection is ongoing. There may also be signs of systemic sepsis with persistent tachycardia, pyrexia, a raised white count and a raised C reactive protein 1.2. Clinical signs of generalised peritonitis: generalised severe abdominal tenderness with rigidity, rebound tenderness and loss of bowel sounds 1.3. Peritonitis caused by pseudomonas species 1.4. Fungal peritonitis 2. The above patients that are not already included in a clinical trial 3. The above patients that consent to participate in the trial |
| Key exclusion criteria | 1. Patients from which formal consent cannot be taken 2. Patients with poor respiratory function that may be put at risk by laparoscopic surgery as assessed by an anaesthetist 3. Patients that have had multiple laparotomy procedures and history of adhesions as a result of the surgery |
| Date of first enrolment | 10/10/2009 |
| Date of final enrolment | 10/10/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
LE5 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/10/2017: No publications found, verifying study status with principal investigator.