Somato-sensory Reflex Arch in Spinal Cord Injury - Effect on Colorectal Transport
|ClinicalTrials.gov Identifier: NCT01274312|
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : May 12, 2014
|First Submitted Date ICMJE||November 8, 2010|
|First Posted Date ICMJE||January 11, 2011|
|Last Update Posted Date||May 12, 2014|
|Study Start Date ICMJE||September 2010|
|Actual Primary Completion Date||September 2013 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Colorectal emptying [ Time Frame: 18 month postoperative for last included patient ]
Colorectal emptying at defecation after somato-autonomic reflex stimulation is mesaured using colorectal scintigraphy pre- and 18 month postoperatively
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01274312 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Somato-sensory Reflex Arch in Spinal Cord Injury - Effect on Colorectal Transport|
|Official Title ICMJE||Somato-sensory Reflex Arch in Spinal Cord Injury - Effect on Colorectal Transport|
Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder dysfunction. Recently, the concept of a surgically created somato-sensory reflex arch for bladder dysfunction in SCI has been introduced. The concept is promising, not just for bladder but also for bowel dysfunction. However, well designed studies need to be performed before recommending the procedure to a large number of patients worldwide. In this study the investigators perform multidisciplinary studies providing necessary information about the clinical outcome of the somato-sensory reflex arch in adult SCI patients.
The hypothesis is as follows:
Spinal cord injury has a profound impact on the lives of those affected. Quality of life is restricted not only by immobility but also by severe neurogenic bladder and bowel dysfunction. For example, 66% of spinal cord injury (SCI) patients have to empty their rectum digitally, 75% suffer from faecal incontinence and 9% spend more than 60 minutes each time they defecate. Neurological impairment due to SCI is permanent and the average age at injury is only 28 years. The longevity of individuals with SCI is approaching that of the general population and, accordingly, most patients have to live for several decades with severe bladder and bowel symptoms. It is estimated that the number of individuals with SCI in Denmark is 3.000 and each year 10.000 persons in the European Union sustain a SCI. Even though clean intermittent catheterization has successfully reduced mortality due to urinary tract infections or reflux and though several new treatment modalities for neurogenic bowel dysfunction have been introduced, both bladder and bowel dysfunction still rank among the top three causes of impairment of quality of life after SCI.
Somato-sensory reflex arch:
The concept was pioneered by professor Xiao. Animal studies and basic clinical research were performed in the United States and later human clinical studies have been done in Wuhan, China. The surgical procedure principle can briefly be summarized as follows:
All spinal nerves have an anterior efferent root and a posterior afferent root. For the somato-sensory reflex arch (or "Xiao procedure") the posterior (afferent or sensory) root of the 5th lumbar nerve (L5) is kept while the anterior root is cut and anastomosed to the anterior root of a lower segment, usually the third sacral segment (S3). Thereby, a new reflex arch has been created from the skin of the leg through the sensory part of L5 to the spinal cord and further through the anastomosis via S2 or S3 to the bladder and bowel. Strong stimuli at the L5 dermatome, i.e. scratching or electrical stimulation, will then initiate voiding (6,7). Effects of the somato-sensory reflex arch on neurogenic bowel dysfunction have not been studied, but clinical experience indicates that bowel management is substantially facilitated.
The Xiao procedure introduces a completely new concept for management of spinal cord lesions and it has been greeted with optimism worldwide. The number of patients operated in China alone is now more than 3.000 and centres in the United States, Germany and Israel have introduced or modified it. Furthermore, centres in Australia, Finland and Denmark plan to introduce it within the present year. There are, however, serious concerns that need to be addressed:
Before the widespread use of somato-sensory reflex arch we find it of utmost importance that well designed studies with validated or even objective endpoints are performed. Results of such studies will have an international impact in either defining indications for a completely new treatment principle or, otherwise, in preventing the widespread use of an ineffective treatment.
In March 2009 the core members of our multidisciplinary study team went on a study tour to Wuhan, China. In Wuhan a staggering number of 600 patients had the somato-sensory reflex arch procedure performed in 2008. Based on experience from our visit we pose the following hypotheses:
Patients and Methods:
Spinal cord injured patients
Internationally, two indications for the somato-sensory reflex arch are emerging:
The relatively minor surgical procedure has been described in previously. In summary: A hemilaminectomy of L5-S1 is performed. By means of neurophysiology testing the 5th lumbar root and 2nd or 3rd sacral roots are identified on one side. The perineurium is opened and the motor roots are separated from the sensory. The motor roots are transsected and a microanastomosis is created between L5 and S2 or S3. After surgery sprouting occurs and after 12-18 months the reflex arch is functional. Time till clinical effect is therefore also 12-18 months. The advantage of the procedure is that it is performed through a hemilaminectomy of only two segments and the surgical stress in relatively small. The patients are expected to be in their habitual condition within 48 hours.
Post surgical monitoring:
Even if patients void during somato-autonomic reflex arch stimulation, they usually do not defecate. In spite of this, it is the clinical experience in China that bowel function improves significantly. This is possible because the left colon and rectum receive stimulatory parasympathetic innervation from the same spinal cord segments (S2-S4) as the bladder. It has been shown in several papers, including some from our own group, that colonic transit times are significantly prolonged in SCI patients. Somato-autonomic reflex stimulation may therefore improve bowel function by increasing colorectal transport during stimulation even in the absence of defecation. As most patients stimulate several times each day the cumulative effect on the colorectum may be considerable and facilitate colorectal emptying when it is otherwise induced.
Our centre has been leading internationally in developing scintigraphic techniques for assessment of colorectal transport at defecation and previously we have found that patients with low SCI have extremely reduced colorectal emptying at defecation. We find that our scintigraphic technique is extremely well suited for the study of colorectal effects from the Xiao procedure.
The total gastrointestinal and segmental colonic transit times of each individual is determined. Based on this information two doses of 111Indium are taken on day-1 (2.6 MBq) and on day-2 or-3 (3.3 MBq). On day-0 patients arrive at our Department of Nuclear medicine at 8 A.M. A double headed Picker Gamma camera is used to image the whole abdomen for ten minutes with patients lying flat on their back (period 1). Then another ten minutes recording will be performed while the relevant dermatome for the somato-autonomic reflex arch is stimulated (period 2). Then subjects are allowed a standardized meal to stimulate the gastrocolonic reflex. Within 30 minutes SCI subjects initiate defecation in their standard way (through staining, digital stimulation, suppositories or micro enema) while sitting at the toilet. Finally, another ten minutes recording is performed to determine colorectal contents after defecation (period 3). The number of counts for each of the ten minutes periods is approximately 80.000. Comparison of the number of counts in each of four segments (the coecum/ascending colon, the transverse colon, the descending colon and the rectosigmoid) allows highly specific description of luminal colorectal transport during stimulation or at defecation. All subjects will only be studied twice: Before surgery and after 18 months. Based on this relatively simple experiment the following three sub-studies can be published:
B1)Colorectal transport at defecation in patients with spinal cord lesions By comparing results from scintigraphy before surgery in patients with supraconal SCI with our previous results among healthy volunteers and patients with low SCI valuable information about colorectal dysfunction in SCI will be obtained.
B2)Colorectal transport during somato-autonomic reflex stimulation By comparing the localization of colorectal contents in periods 1 and 2 before both surgery and after 18 months very detailed information about colorectal transport during somato-autonomic reflex stimulation will be provided.
B3)Colorectal emptying at defecation after somato-autonomic reflex stimulation Substraction of counts in period 3 from those registered in period 2 differences between colorectal emptying and segmental transport at defecation before and after creation of the reflex arch will give detailed objective information about the effects of the Xiao procedure on colorectal emptying.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Spinal Cord Injuries|
|Intervention ICMJE||Procedure: Xiao procedure
Cross over surgery. Proximal part of L5 Ventral root is anastomosed to distal part of ventral root of S2 or S3 producing a somato-sensory reflex arch
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date||September 2013|
|Actual Primary Completion Date||September 2013 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Denmark|
|Removed Location Countries|
|NCT Number ICMJE||NCT01274312|
|Other Study ID Numbers ICMJE||M-20090113 - 1|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||University of Aarhus|
|Study Sponsor ICMJE||University of Aarhus|
|Collaborators ICMJE||Lundbeck Foundation|
|PRS Account||University of Aarhus|
|Verification Date||October 2012|
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