Peritoneal dialysis (PD) peritonitis Digestive System Peritonitis
Conditions
Interventions
Laparoscopic versus conventional open PD catheter removal and peritoneal lavage for PD peritonitis.
Sponsors
University Hospitals of Leicester NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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-a [TNF-a]; 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, reduce | — |
Countries
United Kingdom
Outcome results
None listed