http://blog.sciencenet.cn/home.php?mod=space&uid=385748&do=blog&id=713793NIH扩大评估肖氏手术有效病种，继续资助肖氏手术研究已有 201 次阅读 2013-8-3 13:54 |系统分类:博客新闻|关键词:NIH 肖氏手术 脊柱裂，脊髓损伤，尿失禁
谢谢许培杨撤掉了那篇误导的信息。本来不愿在美国正式结题公布结果前浪费时间多说。
​
真实情况是：
http://www.clinicaltrials.gov/ct2/results?term=rerouting
1，NIH已经认定肖氏手术安全，不再需要原安全评估内容;
2, NIH认定现有SB肖氏手术例数及结果已足够得出统计学结论，本研究不需再增加病例数（否则又要延迟结题至少3年），所以将原计划请NIH出资再作15例的部分撤销，改成现在的题目和内容继续进行、资助。
3， NIH原则认定肖氏手术对脊膜膨出大小便障碍的效果，新的研究内容增加要求扩大评估肖氏手术对SCI及其他类尿失禁的有效水平（level of improvement, 注意：不是评估是否有效，而是有效程度）
看着一些小丑们和方舟子为这“撤销”狂欢乱叫，实在好玩。本来早上就看到微博上有，故意等等看，果然，方舟子跳进坑了：-）这剽窃博士居然草包到基本搜索都不懂。
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Lumbar to Sacral Ventral Nerve Re-Routing
This study is ongoing, but not recruiting participants.
Sponsor:
Kenneth Peters, MD
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00378664
First received: September 19, 2006
Last updated: June 26, 2013
Last verified: June 2013
History of Changes
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Purpose
To assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in Spinal Cord Injury and spina bifida patients
Condition Intervention Phase
Urinary Incontinence
Spinal Cord Injury
Spina Bifida
Procedure: lumbar to sacral ventral nerve re-routing procedure
Phase 2
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lumbar to Sacral Ventral Nerve Re-Routing
Resource links provided by NLM:
Genetics Home Reference related topics: spina bifida
MedlinePlus related topics: Spina Bifida Spinal Cord Injuries Urinary Incontinence Urine and Urination
U.S. FDA Resources
Further study details as provided by William Beaumont Hospitals:
Primary Outcome Measures:
Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients. [ time frame: evaluated at 6 months and 1 year ] [ designated as safety issue: no ]
Secondary Outcome Measures:
Assess the effect of lumbar to sacral ventral the nerve re-routing on bowel function in SCI and spina bifida patients [ time frame: evaluated at 6 month and 1 year visit ] [ designated as safety issue: no ]
Assess the effect of the lumbar to sacral ventral nerve re-routing on health related quality of life in SCI and spina bifida patients [ time frame: evaluate at 6 month and 1 year ] [ designated as safety issue: no ]
Assess the effect of the lumbar to sacral ventral nerve re-routing on ability to perform activities of daily living in SCI and spina bifida patients [ time frame: evaluate at 6 month and 1 year visit ] [ designated as safety issue: no ]
Assess the effect of the lumbar to sacral ventral nerve re-routing on sexual function in SCI patients 18 years of age and older [ time frame: evaluate at 6 months and 1 year ] [ designated as safety issue: no ]
Estimated Enrollment: 12
Study Start Date: September 2006
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.
Procedure: lumbar to sacral ventral nerve re-routingprocedure
surgical nerve re-routing procedure
Detailed Description:
Spinal cord injury (SCI) and spina bifida is a source of irreversible injury to the spinal cord often resulting in paralysis and loss of sensation below the waist. The inability to urinate normally is a consequence of both conditions (neurogenic voiding dysfunction). In spina bifida and spinal cord injury, the nerve that controls the bladder and sphincter (the muscle that squeezes the bladder neck to prevent leaking) may no longer work properly resulting in patients who cannot urinate or are constantly wet.
Most patients will maintain high pressures in their bladder and these elevated pressures will eventually take its toll by causing recurrent urinary tract infections, backup of urine to the kidneys, and marked dilatation of possible further damage to the kidneys. Many patients eventually suffer from irreversible renal (kidney) damage, where dialysis or kidney transplant is the only way to sustain life.
Spinal bifida (present at birth) and SCI (occurs most often early in the fourth decade of life) predominately affect young individuals and longevity and quality of life may be greatly reduced by the presence of bladder, bowel, and sexual dysfunction. In the recent past, medications and catheters were the only way to help cord injured patients empty their bladders. Although clean intermittent catheterization (CIC) provides good maintenance results, medications can help conserve low bladder pressures, and antibiotics sustain an infection free urinary tract, these are difficult bladder management programs to uphold. They are expensive, time consuming, and outcomes are inconsistent.
A new surgical procedure has potential for treatment of spinal cord injuries/ spinal bifida. Recently, Dr. Chuan-Guo Xiao from China developed a surgical procedure of rewiring the nerves in the spinal cord to gain better control of urination and avoid complications of neurogenic bladder. The procedure reconnects live wires (nerves) to dead wires.
Eligibility
Ages Eligible for Study: 6 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
Male and female paraplegics 18 years and older with spinal cord lesion above L1 on a CIC program for bladder management and a score of "A" on ASIA scale.
Male and female patients age 6 and older with myelomeningocele spina bifida (surgically closed at birth) on a CIC program for bladder management.
Neurogenic bladder documented by urodynamic testing.
Stable neurogenic bladder dysfunction of at least 1 year or more.
Compliant bladder wall.
Normal renal function.
Exclusion Criteria:
History of bladder cancer, augmentation, or radiation.
Bladder capacity less than 100 milliliters (ml).
Anatomic outlet obstruction or urethral strictures.
Vesico-ureteric reflux grade 2 or higher.
Presence of an ileal conduit or supra-pubic catheter drainage.
Contraindications to general anesthesia or surgery.
Inability to complete follow up visits for 3 years.
Inability to comprehend and answer self-administered questionnaires.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378664
Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
William Beaumont Hospitals
Investigators
Principal Investigator: Kenneth M Peters, M.D. William Beaumont Hospitals
More Information
Publications:
Xiao CG. Reinnervation for neurogenic bladder: historic review and introduction of a somatic-autonomic reflex pathway procedure for patients with spinal cord injury or spina bifida. Eur Urol. 2006 Jan;49(1):22-8; discussion 28-9. Epub 2005 Nov 2. Review.
Liu Z, Liu CJ, Hu XW, Du MX, Xiao CG. [an electrophysiological study on the artificial somato-autonomic pathway for inducing voiding] Zhonghua Yi Xue Za Zhi. 2005 May 25;85(19):1315-8. Chinese.
Mathews TJ, Honein MA, Erickson JD. Spina bifida and anencephaly prevalence--United States, 1991-2001. MMWR Recomm Rep. 2002 Sep 13;51(RR-13):9-11.
Muller T, Arbeiter K, Aufricht C. Renal function in meningomyelocele: risk factors, chronic renal failure, renal replacement therapy and transplantation. Curr Opin Urol. 2002 Nov;12(6):479-84. Review.
Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00378664 History of Changes
Other Study ID Numbers: 2006-124
Study First Received: September 19, 2006
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board
Keywords provided by William Beaumont Hospitals:
urinary incontinence
spinal cord injury
spina bifida
Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Incontinence
Spinal Dysraphism
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
ClinicalTrials.gov processed this record on August 01, 2013