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Thread: Summary of the clinical trials of omentum transposition in chronic human spinal cord injury

  1. #1

    Summary of the clinical trials of omentum transposition in chronic human spinal cord injury

    I have previously posted a summary of the published clinical trial results on omentum transposition treatment of human spinal cord injury but it is perhaps useful for me to do another one here, so that people can judge for themselves.

    Omentum transposition excited much initial interest when Dr. Harry Goldsmith first introduced it in the 1986. In the 10 years after the procedure was first reported, the evidence that it improves neurological function in people was largely anecdotal derived from isolated case reports. However, between 1996 and 2001, seven clinical studies were published reporting the results of omentum transposition on over 200 patients around the world. Carried out in Texas, United Kingdom, and Moscow, and Yugoslavia, six of the trials reported only minor neurological improvements in 10-20% of the patients. The Yugoslavian trial did not report neurological outcome. All the trials encountered significant complications from the surgery. Except for the Yugoslavian study, which did not make a recommendation, six of the trials concluded that the omentum transposition surgery is not justified given the limited benefit and high risk of complications.

    It would seem to me that anybody considering omentum transposition surgery should understand that this procedure has not been proven to improve neurological function, especially when applied to people with "complete" chronic spinal cord injury. Because none of the trials were controlled, some of the minor beneficial effects observed in the trials may have been due to decompression, removal of adhesions, or untethering of the spinal cord. None of the trials included intensive rehabilitative training after the surgery. Also, it is possible that none of these surgeons are as good at the procedure as Dr. Goldsmith. Nevertheless, the spate of negative clinical trial results should give people pause for thought before they undergo this expensive and invasive procedure. The individual trials are summarized with abstracts below.

    Clifton, et al. (1996) at the University of Texas in Houston did omentum transposition on 13 people who had "complete" spinal cord and were followed for 1-4 years; of these 6 showed some functional recovery in the form of reduced spasticity and improved truncal support. However, neurological testing did not show a significant improvement in the function of limb movements or sensation. The transposed patients also did not differ significantly with 8 other patients with similar injury timing and severity. One patient died from pulmonary embolus and 3 patients had post-surgical wound fistulas that required reoperation. The authors concluded that there was no justification for further clinical trials of the treatment in people with complete spinal cord injury.

    Sgouros & Williams (1996) from Birmingham UK published a clinical trial of pediculated omental graft transposition in 10 patients with complete or partial paraplegia and who were on average 9.7 years after injury. The patients were showing progressive worsening of symptoms starting 5-6 years before. They followed up the patients for over 2 years. Of these 10 patients, only two showed improvement, two remained unchanged, and five continued to deteriorate. Like Clifton, et al., they found a significant incidence of complications from the surgery. They conclude that the procedure "did not seem to improve the prognosis of the injured cord and was associated with significant morbidity".

    Baskov, et al., (1998) from Russia described 40 cases of omental transposition in spinal cord injury. They found neurological improvement in 17.5% of the patients. Improved segmental functions were observed 7-90 days after surgery but no neurological improvement at 6 months. Patients with mild spinal cord injury at T10-L1 showed the best outcomes. Comparison with 115 patients that had been treated with another procedure called meningomyloradicolysis suggests no significant effect of the procedure. They concluded "it is not justifiable to use omental transposition in late spinal cord injury".

    Sokolova, et al. (1999) from Russia studied somatosensory evoked potentials in 25 patients who received omentum transpositions (omentomyelopexy). This test involves stimulation of a leg nerve and recording the responses from the scalp overlying the part of the brain that is activated. They saw some enlargement of the evoked potentials recorded from below the injury site. Again, like the other Russian studies from the Burdenko Institute in Moscow, they found 16-20% incidence of improvement of evoked potentials in the spinal cord below the injury site but no evidence of transmission of the evoked potentials across the injury site. They found a correlation between the evoked potentials and evidence of urological function. They conclude that there were minor positive changes in the spinal cord below the injury site.

    Duffill, et al. (2001) from Southampton UK did a prospective clinical trial of omentum transposition in 17 patients with chronic spinal cord injury. Detailed assessments of the patients at 3, 6, and 12 months after surgery showed only minor and subjective change in neurological function. One patient had neurological deterioration and there were 20 surgical complications including urinary tract infections, deep vein thrombosis, wound infection, and incisional hernia. The authors concluded that "continued use of this operation in this situation is not supported by this study."

    Spaic, et al. (2001) in Russia assessed 7 patients who had received vascular omental pedicle at 2-5 years. They reoperated on the patients and were able to visualize the pedicled flap. The authors conclude that "detailed analysis of the actual neurological condition of these patients compared to neurological condition assessed before the implantation of the pediculated-vascular omental graft revealed neither sensory nor motoric improvement (in the post-implantation period)".

    Ignajatovic, et al. (2001a,b) in Yugoslavia reported their experience in 100 omentomyelopexy of the spinal cord. Six patients had complications that include pneumothoraces, two lesions of the spleen, one pneumonia, and one wound infection. They found that the transposed omental flap did vascularize the spinal cord but unfortunately did not describe neurological changes associated with the procedure.

    In summary, these clinical trials suggest that omental transposition surgery in people with chronic spinal cord injury, particularly those with "complete" spinal cord injury, produced only minor neurological improvements in 10-20% of people and had a relatively high risk of post0perative complications.

    Wise.

    References Cited

    • Goldsmith HS, Neil-Dwyer G and Barsoum L (1986). Omental transposition to the chronically injured human spinal cord. Paraplegia 24:173-4. Summary:

    • Clifton GL, Donovan WH, Dimitrijevic MM, Allen SJ, Ku A, Potts JR, 3rd, Moody FG, Boake C, Sherwood AM and Edwards JV (1996). Omental transposition in chronic spinal cord injury. Spinal Cord 34:193-203. Summary: The results of omental transposition in chronic spinal cord injury have been reported in 160 patients operated upon in the United States, Great Britain, China, Japan, India and Mexico, with detailed outcomes reported in few studies. Recovery of function to a greater degree than expected by natural history has been reported. In this series, 15 patients with chronic traumatic spinal cord injury (> 1.5 years from injury) underwent transposition of pedicled omentum to the area of the spinal cord injury. Of the first series of four patients who were operated upon in 1988, one died, one was lost to follow-up and two were followed with sequential neurological examinations and Magnetic Resonance Imaging (MRI) scans preoperatively, at 1 year post injury and 4 1/2 years post injury. Another 11 patients were operated in 1992 and underwent detailed neurological and neurophysiological examinations and had MRI scans preoperatively and every 4 months for at least 1 year after surgery. All patients completed a detailed self-report form. Of the total of 13 operated patients in both series followed for 1-4 1/2 years, six reported some enhanced function at 1 year and five of these felt the changes justified surgery primarily because of improved truncal control and decreased spasticity. MRI scans showed enlargement of the spinal cord as compared to preoperative scans in seven patients. Increased T2 signal intensity of the spinal cord was found by 1 year after surgery in eight of 13 operated patients. Neurophysiological examinations of 11 patients in the second series agreed with self-reports of increases or decreases in spasticity (r = 0.65, P < 0.03). Somatosensory evoked potentials and motor evoked potentials at 4 month intervals up to 1 year in these patients showed no change after surgery. Neurological testing, using the American Spinal Injury Association [ASIA) and International Medical Society of Paraplegia [IMSOP) international scoring standards, failed to show any significant changes when the 1-year post operative examination was compared to the first preoperative examination except for decreased sensory function after surgery which approached statistical significance. When the 11 patients in the second series were compared to eight non-operated matched patients, followed for a similar length of time, no significant differences were found. Complications encountered in the operated patients from both series included one postoperative death from a pulmonary embolus, one postoperative pneumonia, three chronic subcutaneous cerebrospinal fluid [CSF) fistulae requiring wound revision, and one patient who developed biceps and wrist extensor weakness bilaterally requiring graft removal. We conclude that the omental graft remains viable over time and this operation can induce anatomical changes in the spinal cord as judged by MRI. Some patients reported subjective improvement but this was not supported by objective testing. We, therefore, find no justification for further clinical trials of this procedure in patients who have complete or sensory incomplete lesions. Further testing in motor incomplete patients would seem appropriate only with compelling supportive data. Department of Neurosurgery, University of Texas-Houston Medical School, USA.

    • Sgouros S and Williams B (1996). A critical appraisal of pediculated omental graft transposition in progressive spinal cord failure. Br J Neurosurg 10:547-53. Summary: A critical review of patients who had pediculated omental grafting for progressive spinal cord failure was performed in order to assess the impact of this procedure on the natural history of the spinal cord function after spinal cord injury. Ten patients were reviewed; all had complete or partial paraplegia. Mean age at injury was 29.1 years. There was an average interval of 9.7 years between injury and onset of progressive worsening of symptoms, and 5.6 years between onset of such symptoms and diagnosis. Average follow-up was 24.5 months. Five patients underwent omental grafting as primary surgical treatment whereas the other five had earlier procedures. One patient died on the postoperative period. Significant morbidity was also observed. All the surviving patients were asked to score themselves by answering a questionnaire exploring the effect of surgery in limb function and performance on activities of daily living. Only two patients improved following the procedure. Two others remained unchanged, while the remaining six continued to deteriorate. There was no difference in clinical outcome between the primary surgery group and the ones that had had previous procedures. Delayed omental grafting done as tried in this clinic did not seem to improve the prognosis of the injured cord and was associated with significant morbidity. Midland Centre for Neurosurgery and Neurology, Birmingham, UK.

    • Baskov AV, Shevelev IN, Iarikov DE, Iundin VI, Kolpachkov VA and Sokolova AA (1998). [The results of omentomyelopexy in the late period of traumatic spinal cord disease]. Zh Vopr Neirokhir Im N N Burdenko 17-9. Summary: The results of omental transplantation to the site of spinal cord lesion in 40 patients in late injury are given. Neurological deficit was alleviated in 17.5% of patients. Improvement of segmentary functions was observed in most cases and was recorded within 1 week to 3 months postoperatively. There was no neurological improvement after 6 months postoperatively. Patients with mild spinal cord injuries (D10-L1) had the best outcomes. Comparative analysis of the outcomes of omentomyelopexy with those of treatment in 115 patients undergone meningomyeloradicolysis did not demonstrate any significant difference. Thus, it is not justifiable to use omental transposition in late spinal cord injury.

    • Sokolova AA, Iundin VI, Iarikov DE, Kolpachkov VA, Baskov AV and Shevelev IN (1999). [Changes in the somatosensory evoked potentials of patients with complicated spinal trauma after an omentomyelopexy operation]. Zh Vopr Neirokhir Im N N Burdenko 15-20. Summary: The purpose of the study was to record somatosensory evoked potentials (SSEP) to objectify the results omentomyelopexy in late spinal cord injury. SSEP were recorded in 25 patients in leads of three levels of the somatosensory tract (from the popliteal fossa, from the lumbar enlargement of the spinal cord, and from the surface of the skull in the region of projection of leg presentation in cerebral hemispherical cortex) before and after surgery. The study indicated that there were no pre- or postoperative records of cortical evoked potentials. At the same time there was improvement in the magnitude of SSEP at the level of the lumbar enlargement (36%). In 4 (16%) and 5 (20%) cases of them SSEP changes were clear and unclear, respectively. The assessment of SSEP changes requires consideration of cases with unclear SSEP. Comparison of the results with clinical findings shows a correlation mainly with urological and urodynamic evidence. Thus, there are minor positive changes in the magnitude of SSEP after omentomyelopexy in the lumbar enlargement lead with unclearly pronounced evoked potentials.

    • Duffill J, Buckley J, Lang D, Neil-Dwyer G, McGinn F and Wade D (2001). Prospective study of omental transposition in patients with chronic spinal injury. J Neurol Neurosurg Psychiatry 71:73-80. Summary: OBJECTIVES: This prospective study was designed to assess the effects of omental transposition in patients with a chronic spinal injury. METHODS: Neurological status was established to be stable and multiple baseline across patient studies were done preoperatively and repeated postoperatively. Assessments included activities of daily living (ADL), functional ability, degree of spasticity, motor power, sensation, pain perception, urodynamic studies, electromyography, sensory evoked potentials (SEPs), and infrared thermography to measure peripheral and general skin vascular responses. Each patient had MRI. Assessments were done at 3, 6, and 12 months after omental transposition in 17 patients. RESULTS: The detailed assessments failed to show significant improvement, although some patients showed minor objective and subjective change in some categories. Neurological deterioration occurred in one patient. There were 20 surgical complications including urinary tract infection, deep vein thrombosis, wound infection, and incisional hernia. CONCLUSIONS: Omental transposition has not been shown to improve neurological function in 17 patients with chronic spinal cord injury, and continued use of this operation in this situation is not supported by this study. Further advances in spinal cord repair may utilise the pedicled omental graft to provide an alternative vascular supply, but its current use should be limited to experimental models. Department of Neurosurgery, Wessex Neurological Centre, Southampton University Hospitals Trust, Tremona Road, Southampton SO16 6YD, UK.

    • Spaic M, Minic L, Djitic R, Lukic Z and Tadic R (2001). [Omentomyelosynangiosis--a direct intraoperative observation]. Vojnosanit Pregl 58:249-54. Summary: The late outcome of implantation of the vascular omental pedicle on the injured spinal cord performed in 7 patients to improve functional recovery through revascularization of the injured cord tissue is reported. All the patients were reoperated at the same spinal level 2-5 years after the omental pedicle implantation for the treatment of chronic neuropathic spinal pain by employing DREZ (Dorsal Root Entry Zone lesion) surgery. From the technical standpoint it was necessary to mobilize the implanted omental pedicle from the cord surface to provide the access to dorsolateral cord sulcus for the DREZ operation. Mobilization of the omental pedicle provided unique opportunity to observe omental-cord contact surface (omentomielosinangiosis) that is believed to stimulate revascularization of the cord tissue. In our report particular attention was paid to the specificity of the omental-cord contact surface and the late tissue changes of the cord as well as omental tissue knowing the fact that the capacity of omental tissue to stimulate neoangiogenesis still represents the actual doubt in neurobiological theory and practice. Detailed analysis of the actual neurological condition of these patients compared to neurological condition assessed before the implantation of the pediculated-vascular omental graft revealed neither sensory nor motoric improvement (in the postimplantation period). The effect of DREZ surgery of the chronic neuropathic spinal pain was not a topic of this report.

    • Ignjatovic M, Cuk V, Bjelovic M and Minic L (2001). [Complications in omentopexy and personal experience with 100 omentomyelopexies]. Vojnosanit Pregl 58:585-93. Summary: Abdominal and general complications of omentomyelopexies are seldom seen, and were mostly presented as the case reports. The aim of this study was to present in a comprehensive analysis of the data acquired from literature the reported omentopexy complications, and to compare them with our own results of the application of the omental flap with left gastroepiploic blood vessels. Prospective clinical research included the first 100 operated patients with injuries on different spinal cord levels. In all patients the omental flap was prepared by our original surgical technique and led to the site of the spinal cord lesion. In 6 of our patients we noticed seven complications and those were: three iatrogenic pneumothoraxes, two lesions of the spleen (without splenectomy), one pneumonia and one mild infection of the laparotomy wound. Prevalence of the complications related to the abdominal act of omentomyelopexy of 7% was significantly lower than in those presented in the literature with other right gastroepiploic artery omentopexies (20-79%). In our patients complications occurred earlier, lasted shorter and had no permanent implications for the patients' health. By using the omental flap with left gastroepiploic blood vessels it was possible to perform effective, relatively simple and safe omentomyelopexy for the injuries on all levels of the spinal cord. Such a mode of omental flap preparation with left gastroepiploic blood vessels could be applied for other omentopexies as well.

    • Ignjatovic M, Pervulov S, Cuk V, Kostic Z and Minic L (2001). Early angiogenic capabilities of the transposed omental flap after omentomyelopexy. Acta Chir Iugosl 48:41-3. Summary: Abundant in blood and lymph vessels, capable to adhere to the surface of every lesion, with capillary overgrowing in 4-6 hours, omentum represents almost very suitable organ for revascularization of the ishaemic nervous tissue. Angiographic study of the omentum, especially of the surgically developed omental flap have been rarely performed in clinical practice. The aim of this study was evaluate the angiographic features of the omental flaps after omentomyelopexy. Omentomyelopexy based on the left gastroepiploic vessels was performed in 100 patients of different levels spinal cord injuries. In order to study the omental flap's vascularization, selective angiography of the splenic artery was performed in three patients at the 10th postoperative day. In one patient, angiographic finding showed the establishment of anastomosis between omental flap's arteries and vertebral and spinal artery and in that way, almost incredible angiogenic capabilities of omentum have been proved. Besides confirmation of vitality and good vascularization of the extraperitonealy transposed omental flap, an extraordinary angiogenic capabilities of the omentum have been proved as early as at the 10th postoperative day. To our best knowledge the angiographic findings of this kind have not been published so far. Clinic of General and Vascular Surgery, Military Medical Academy, Belgrade, Yugoslavia.

  2. #2
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    Dr. Young,
    Some of these are from 2001, the same year you spoke favorably about what Dr. Goldsmith is doing. The rest were done before your favorable comments.
    How many of these "trials" deviated from protocol?
    What was the rehabilitation regime?
    How long and how intense was the rehabilitation?
    Were all the rehabilitation techniques the same?
    How dedicated were the patients to the rehabilitation?
    To many variables to draw conculsions.

    I still go with what my eyes have seen. Not very clinical but my eyesight is pretty good.

    Many of the problems posted, ie. infection, UTI's, Pnumonia, etc. have nothing to do with the procedure. These things are a fact of life in any hospital setting and getting worse all the time.

    [This message was edited by 1uncleED on 01-23-03 at 20:19.]

  3. #3
    1UncleEd,

    I don't know. Seven groups of neurosurgeons tried the procedure in over 200 patients and six got similar results of 10-20% of the patients showing minor neurological improvements. Note that while the Yugoslavian group did not report the neurological results, if they had gotten good results, I think that they would have crowed them from the rooftop. I have talked to Dr. Goldsmith about the procedures that these groups used and his opinion was that they did not do the surgery correctly. That may be. But it is not clear what the differences in the protocol were that made all these trials have similarly unimpressive results. The Clifton group thinks that the omentum was placed correctly and had revascularized the spinal cord on the basis of MRI evidence. Spaic, et al. apparently went as far as to re-operate on the spinal cords of 7 patients to see whether the omentum was still alive; they think that the omentum was alive and had revascularized the cord. But, neither group saw much functional recovery in their patients.

    Regarding rehabilitation, it is true that none of the clinical trials required their patients to undergo intensive rehabilitation such as weight-supported ambulation training. Like you, I have long been of the opinion that intensive rehabilitation would be helpful for optimizing recovery. On the other hand, I don't think that Dr. Goldsmith was requiring his patients to undergo special exercises or intensive ambulation training after his surgery.

    If seven surgical groups could not do the procedure correctly in over 200 patients, this suggests that the procedure is not easy. I don't think that all of Dr. Goldsmith's patients had improvement. I have talked to several people who had been operated on by Dr. Goldsmith and they have not recovered function after his surgery. Of course, you know several who seem to have recovered a lot. It would be of interest to find out how the 20 patients that Dr. Goldsmith operated on in Boston are doing.

    By the way, I am fascinated by the omentum and think that it is very interesting but if you look at the postings that I did, I had a similar review of the literature indicating my skepticism that the treatment restores function in patients. If you remember, you actually had Dr. Goldsmith write a response to one of my postings on the subject.

    Wise.

    [This message was edited by Wise Young on 01-23-03 at 20:48.]

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    Dr. Goldsmith knows very well that rehabilitaion
    is a major commponent and I don't think he will do the procedure if the patient is not willing or interested in the intensive rehabilitation.

    [This message was edited by 1uncleED on 01-24-03 at 03:03.]

  5. #5
    Great information Dr. Y.

    Does this mean that we can finally put this omentum debate to bed?

    I think that the conclusions (from many resources) are pretty clear. 10-20% chance of improvement.

    80-90% chance of no improvement. Add to that health (safety) issues that, to me, are to be seriously considered. Sounds like quite a few patients had some complications.

    Whether those complications were from the procedure or hospital conditions related to recovery, who knows? My question then would be how healthy were the candidates going in? And were they sufficiently pre-screened? Or, can anyone, regardless of protocol requirements undergo this treatment provided they have the desire and enough money?

    Not worth the risk to me.

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    Phebus,

    No! These studies did not follow protocol and there is no mention of rehabilitation.

    Without rehab how can one say it does not work.
    Nobody ever claimed that this was some kind of instant cure. Post-op effort and dedication by the patient to strengthen the body is essential.
    The procedure facilitates the body to heal. Intensive rehabilitation to restore atrophy, relearn balance, etc., is all a big part of the picture .
    Non of these "studies" mentioned anything about rehabilitation.

  7. #7
    Senior Member X-racer...'s Avatar
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    What's that old saying "you can bring a horse to water but you cant make him drink" does that apply here ????


    "Phebus" i like the word play (it wouldn't be a slam on someone would it )

    LIVE IT UP AND LIVE IT LARGE!!!!

  8. #8
    1UE. Correct, there is no mention of rehab.

    However, there is mention of "morbidity" (death) as well as many more complications that would tend to deter not entice someone to take such a risk. The risk / reward ratio is unfavorably balanced towards the negative (too risky).

    How much data does one need to be convinced that 10-20% chance does not outweigh 80-90% risk?

    Sorry, but the data, as witnessed above, just isn't there (with our without rehab) regardless of the anecdotal stories of great success. The idea and basis behind a clinical trial is to confirm or deny that a particular application works or doesn't work. OT was designed purely in and of itself to restore neurological function. It has proven to not be effective.

    If one was to undergo OT with intensive rehab attached then that would be a seperate and distinct trial of its own wouldn't it?

    OT by itself is one thing- a unique trial/experiment done by Dr. Goldsmith. Rehab programs like ProjectWalk and Arnie F's are also unique trials/experiments whose data is also seperate and distinct. To combine them would then offer a third seperate and distinct set of data wouldn't it?

    So, in essence, you could be correct 1UE that OT along with intense rehab could possibly restore function. However, to be fair, I think that its only prudent and you have to admit that OT, alone, does not work. Based upon what we know don't you agree?

    And if you, 1UE, are not convinced of anyone's logic to the contrary of your belief then there is a simple solution. Have the procedure done yourself, engage in an intensive rehab program, and report back to us your results?

    In the meantime can we agree that the data shows that OT, alone, does not return function in 80-90% of the patients who have undergone the procedure? I realize that its a tough pill to swallow but its hard to argue with the data.

    X-Racer

    [This message was edited by Phebus on 01-24-03 at 14:01.]

  9. #9
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    Many of the patients who had the omentum transposition did go through rehab, a scam of a rehab in Houston, Texas. JUST BE CAUTIOUS !!!!!!

  10. #10
    Bottom line,

    Given what is happening in China, Australia, and Portugal . . . as well as CR's comments on therapuetic cloning going to human trials . . . one would be a fool at this point to attempt OT, whether its 20, 40, or 60 percent effective.

    Move on . . . please.

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