Condition category
Digestive System
Date applied
19/10/2009
Date assigned
30/11/2009
Last edited
19/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Nicholson

ORCID ID

Contact details

Transplant Group
University Hospitals of Leicester
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UHL 10636

Study information

Scientific title

A randomised controlled trial of conventional open versus laparoscopic surgery for peritoneal dialysis (PD) peritonitis

Acronym

Study hypothesis

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

Leicestershire, Northamptonshire and Rutland Research Ethics Committee 2, 30/01/2009, ref: 08/H0402/132

Study design

Randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Peritoneal dialysis (PD) peritonitis

Intervention

Laparoscopic versus conventional open PD catheter removal and peritoneal lavage for PD peritonitis.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Post-operative pain levels and analgesic requirements. The following outcome data will be 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 will be 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 will be recorded by the nursing staff and pain team using the standard PCAS (Patient Controlled Analgesia System) form. This will include 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 will include 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 will also be recorded.
1.2. At the time of discharge, patients will be 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 will also be 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 will then be assessed again at the one and three monthly clinic appointments.

2. Respiratory function:
2.1. This will be 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 will include 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 will also be recorded.

5. Post operative recovery:
5.1. The Multidimensional Fatigue Inventory (MFI-20) will been given to the patient at the one and three month clinic visit 7. The questionnaire will assess general fatigue, physical, reduced activity, reduced motivation and mental fatigue.
5.2. More complex care abilities will be assessed pre operatively then at the one and three monthly clinic visits using the Instrumental Activities of Daily Living scale (IADL) 6, again measured 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 trial start date

10/10/2009

Overall trial end date

10/10/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

10/10/2009

Recruitment end date

10/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester
Leicester
LE5 4PW
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

c/o Professor D Rowbotham
Research & Development Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospitals of Leicester NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Leicester (UK)

Alternative name(s)

UoL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes