Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LREC number 06/Q0601/46, protocol dated 25/05/06 v1
Study information
Scientific title
Prospective randomised double-blind placebo-controlled crossover study of sacral nerve stimulation in patients with severe rectal evacuatory dysfunction and rectal hyposensitivity
Acronym
Study hypothesis
Patients with constipation secondary to a rectal evacuatory disorder and rectal hyposensation will derive symptomatic improvement, with normalisation of rectal sensory thresholds to balloon distension, following sacral nerve stimulation.
Ethics approval
Redbridge and Waltham Forest Local Research Ethics Committee approved on 14th August 2006 (ref: 06/Q0601/46)
Study design
Single centre randomised placebo-controlled double-blind crossover pilot study
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 found in the interventions field below to request a patient information sheet
Condition
Constipation
Intervention
1. Anorectal physiology: this will take 30 minutes; patients selected for the study will be required to have full anorectal physiology investigations. This will consist of anal manometry, rectal sensory thresholds, pudendal nerve stimulation, endoanal ultrasound, defaecating proctogram and colonic transit study.
2. Implantation of the temporary sacral nerve stimulation wire - this will take up to 60 minutes and can be done under local or general anaesthetic depending on patient choice. Throughout the procedure an image intensifier will be used intermittently to take x-rays, for a total of 2 - 3 minutes.
3. Rectal sensory thresholds - this will take up to 5 minutes; subjects will have rectal sensory thresholds to balloon distension after two weeks, at the crossover period, and at the end of the trial at 4 weeks. This consists of a balloon on the end of a catheter which will be placed into the rectum through the anus. The balloon will be inflated with air and note will be made of the volume required before the subject has the first constant sensation (FCS), a sustained desire to defaecate (DDV) and the maximum volume they can tolerate (MTV).
4. Questionnaires related to quality of life (36-item short form health survey [SF36], Gaol), symptom scores (Wexner constipation scores) will be completed at the end of two weeks and then again at the end of 4 weeks
Intervention is sacral nerve stimulation, each patient has this for 4 weeks in total 2 with stimulation off (ie placebo and therefore the control), 2 weeks with the stimulation on. Neither investigator or patient knows which arm of the trial they are in. The blinding is removed at the end of the 4 weeks.
Contact Details for Patient Information Material:
Chetan Bhan
Specialist Registrar
Academic Surgical Unit
The Royal London Hospital
London E1 1BB
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Normalisation of rectal sensory thresholds to balloon distension (first constant sensation, defaecatory desire volume, maximum tolerable volume)
2. Improvement in Cleveland Clinic Constipation scores
3. Increase in percentage of complete bowel movements from the bowel diaries
Measured at baseline then after two weeks and then after 4 weeks.
Secondary outcome measures
Improvements in the following criteria during the stimulation period:
1. Quality of life using validated methods of assessing health related quality of life (SF36) and gastrointestinal related quality of life (GIQoL)
2. Data from bowel diaries
Measured at baseline then after two weeks and then after 4 weeks.
Overall trial start date
14/08/2006
Overall trial end date
01/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients aged 18 - 65 years, either sex
2. Incomplete and/or assisted evacuation
3. Idiopathic (no rectal surgery, no spinal and overt neurological history)
4. Failed maximal conventional therapy
5. Normal colonic transit and rectal diameter
6. No significant mechanical obstructive abnormality on proctography
7. Unable to evacuate greater than 60% contrast in 3 minutes
8. Rectal hyposensation (based 2/3 abnormal values of first constant sensation [FCS], defecatory desire [DDV] and maximum tolerable volume [MTV] to balloon distension)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Inability to provide informed consent
2. Severe concomitant medical conditions precluding randomisation to operative treatment
3. Neurological diseases such as diabetic neuropathy, multiple sclerosis and parkinson's disease
4. Other medical conditions precluding stimulation: e.g. bleeding disorders, certain cardiac pacemakers
5. Congenital anorectal anomalies or absence of native rectum due to surgery
6. Present evidence of external full thickness rectal prolapse
7. Previous rectal surgery (rectopexy/resection) done less than 12 months ago (24 months for cancer)
8. Stoma in situ
9. Chronic bowel disease such as inflammatory bowel disease, chronic uncontrolled diarrhoea
10. Anatomical limitations that would prevent successful placement of electrodes
11. Pregnancy or intention to become pregnant
12. Previous experience of sacral nerve stimulation (SNS)
Recruitment start date
14/08/2006
Recruitment end date
01/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Academic Surgery
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Queen Mary, University of London (UK)
Sponsor details
c/o Gerry Leonard
Queen Mary's Innovation Centre
Barts and the London School of Medicine and Dentistry
Joint Research and Development Office
Lower Ground Floor
5 Walden Street
Whitechapel
London
E1 2EF
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
University/education
Funder name
Barts and the London School of Medicine and Dentistry, Queen Mary University of London (UK) - Colorectal Development Unit, Academic Surgical Unit
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22418005
Publication citations
-
Results
Knowles CH, Thin N, Gill K, Bhan C, Grimmer K, Lunniss PJ, Williams NS, Scott SM, Prospective randomized double-blind study of temporary sacral nerve stimulation in patients with rectal evacuatory dysfunction and rectal hyposensitivity., Ann. Surg., 2012, 255, 4, 643-649, doi: 10.1097/SLA.0b013e318247d49f.