The Risk of the Xiao Procedure

By xysergroup | 3月 4, 2010

For readers to better understand the risk of the Xiao Procedure, we extract the corresponding evidence from the enclosed supporting material of the Open Letter of Complaint against the Xiao Procedure, listed in chronological order below. From which readers can find different descriptions of the risk from different sources, or from the same source (Beaumont Hospitals) but different times or occasions. We specifically note that the risk was much understated by Beaumont at the beginning when the clinical trial first started, and that the description of the complications is rather vague in its one-year clinical report.

1. August, 2004. Opinion of the expert evaluation panel organized by the Ministry of Health of China
http://xysblogs.org/wp-content/blogs/107/uploads/xpletter.html#nw3

The spinal continuity of this type of children patients is not broken. A functioning healthy somatic motor nerve bundle must be sacrificed in order to construct an artificial reflex arc to control the bladder, which carries very high risks.

2. July 2-4, 2005. Xiao’s non-existent report [25] cited by his review paper
http://www.ncbi.nlm.nih.gov/pubmed/16314037

Occurrence rate of partial loss of the left L4 or L5 motor function after surgery, the only complication for 25% of the first 20 cases, has been dramatically reduced to 5% with only slighter and recoverable muscular weakness by using only half of the lumbar ventral root [25].

3. February 18, 2007. Surgery Might Aid Bladder Control after Spine Surgery
http://www.nctimes.com/lifestyles/health-med-fit/article_8b6c668a-94bb-59fc-b7d3-266bef6ecbe3.html

Lauran Neergaard, Associated Press
There are some risks, Peters cautioned, including general anesthesia and wound infections. For children with spina bifida who can walk, rerouting the thigh nerve causes a small risk of some foot weakness.

4. April 17, 2008. Beaumont Hospitals’ press release
https://www.beaumonthospitals.com/news-story-beaumont-results-urinary-nerve-rewiring-surgeries-spina-bifida-patients

Possible side effects of the surgery include mild postoperative spinal fluid leakage, lower extremity weakness and headache. Recent changes in the surgical technique have dramatically decreased the incidence of these complications. Standard risks associated with any surgery may include bleeding and infection.

5. March 15, 2009. Experimental Surgery Helps Relieve Kids with Spina Bifida and Spinal Injuries
http://www.tampabay.com/features/humaninterest/article984049.ece

By John Barry, Times Staff Writer

Peters said the major complication was leg weakness that developed among eight of the nine with spina bifida. All had been able to walk before the surgery. They often required intense physical therapy, Peters said, “just to get them back to baseline.” One child developed drop foot, meaning he could not raise his foot when he walked.

6. April, 2009. Beaumont Hospitals’ one-year clinical report.
http://linkinghub.elsevier.com/retrieve/pii/S0022534709608843

Perioperative complications included foot-drop in 1 patient, wound drainage in 3 patients, and prolonged inability to bear weight in 1 patient. At 1 month, neurological examination revealed major changes in gait in 2/9. 8/9 displayed variable weakness of one or more lower extremity muscle groups. 8 of 9 patients returned to or near baseline at 12 months with physical therapy and time.

7. Nov 12, 2009. Investigation report from pro-bono lawyers in China
http://xysblogs.org/wp-content/blogs/107/uploads/xpletter.html#nt1

(Among 74 patients being interviewed)
Weakness and atrophy in leg and foot: 1
Deformity in foot: 1
Atrophy in leg and foot, with slightly abnormal gait: 7
Deformity in leg and foot, with lameness or obvious abnormal gait: 21

(Update) 8. Aug 2010. The Journal of Urology, Vol. 184, No. 2
http://www.jurology.com/issues/contents?issue_key=S0022-5347%2810%29X0008-8

New Horizons in Managing Lower Urinary Tract Dysfunction in Children, by Piet Hoebekea.
…Persistent foot drop cannot be considered a minor complication in children who are already motor disabled.

Editoral Comments, by John M. Park
…Unless the innovators provide a sound argument and data for the validity of the procedure, there is a great danger of its improper and rapid adaptation by patients and the medical community at large.

(Update) 9. Oct 2010. Patients protest Chinese doctor’s risky surgery
http://news.yahoo.com/s/ap/20101019/ap_on_he_me/as_china_risky_medicine

Gillian Wong, Associated Press
Dr. Kenneth Peters, the hospital’s head of urology, said he ensures that patients are fully aware the surgery is experimental and carries serious risks.

 

 

Topics: Xiao Chuanguo |

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