Conventional open versus laparoscopic surgery for peritoneal dialysis (PD) peritonitis
| ISRCTN | ISRCTN55802603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55802603 |
| Secondary identifying numbers | UHL 10636 |
- 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
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
Prof Michael Nicholson
Scientific
Scientific
Transplant Group
University Hospitals of Leicester
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
Study information
| Study design | Randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | Post-operative pain levels and analgesic requirements. The following outcome data are collected: 1. Duration of the surgical operation (time from first incision to last skin suture) 2. Post-operative pain levels and analgesic requirements: 2.1. Pain assessed daily using a linear analogue scale (100 mm line with 'no pain at all' written at the left hand (zero) end and 'worst pain imaginable' written at the right hand (100) end 2.2. Post-operative analgesic use recorded by the nursing staff and pain team using the standard PCAS (Patient Controlled Analgesia System) form. This includes the total dose of morphine used in mg and the duration of PCAS use in hours |
| Secondary outcome measures | Return to normal activities and post-operative respiratory function. 1. Resumption of normal activities: 1.1. In-patient assessment includes grip strength, measured pre operatively then daily whilst an in-patient and in the clinic one and three months postoperatively. The timed Up and Go measured pre operatively, then at three and five days post operatively, at discharge, then at the one and three monthly clinic visits (patients are timed as they rise from a standard chair, walk 3 metres, turn, walk back and sit). The duration of post-operative in-patient stay is also recorded. 1.2. At the time of discharge, patients are assessed on their Activities of Daily Living (ADL) 6 by scoring the following activities on a 3 point scale. (1: no help needed, 2: needing help, 3: unable to do). An assessment is also made pre operatively: 1.2.1. Grooming 1.2.2. Feeding 1.2.3. Toileting 1.2.4. Bathing 1.2.5. Dressing 1.2.6. Transferring from bed to chair 1.2.7. Walking across a room These are then assessed again at the one and three monthly clinic appointments. 2. Respiratory function: 2.1. Assessed preoperatively and on the first, third and fifth postoperative days by spirometry (Forced expiratory volume in one second [FEV1] and forced vital capacity [FVC]). 3. The metabolic response to surgery: 3.1. Investigated by daily measurements of C-reactive protein and plasma cytokine levels (tumour necrosis factor-α [TNF-α]; interleukin-1 [IL-1] and IL-6). 4. Complication rates: 4.1. This includes mortality, wound complications (infection, hernia), chest complications (infection, pneumonia, atelectesis), thrombo-embolic disease (deep vein thrombosis, pulmonary embolism) and any other adverse event. Re-operation rates for persisting infection are also recorded. 5. Post operative recovery: 5.1. The Multidimensional Fatigue Inventory (MFI-20) is given to the patient at the one and three month clinic visit 7. The questionnaire assesses general fatigue, physical, reduced activity, reduced motivation and mental fatigue. 5.2. More complex care abilities are assessed pre operatively then at the one and three monthly clinic visits using the Instrumental Activities of Daily Living scale (IADL) 6, again on a 3-point scale: 5.2.1. Using the telephone 5.2.2. Accessing transportation away from home 5.2.3. Shopping 5.2.4. Preparing meals 5.2.5. Housework 5.2.6. Laundry 5.2.7. Managing medication 5.2.8. Managing finances |
| Overall study start date | 10/10/2009 |
| Completion date | 10/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Professor D Rowbotham
Research & Development Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Website | http://www.uhl-tr.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Hospital/treatment centre
University Hospitals of Leicester NHS Trust (UK)
No information available
University of Leicester (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- UoL
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
02/10/2017: No publications found, verifying study status with principal investigator.
