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result(s) for
"Decompression, Surgical - instrumentation"
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Percutaneous Epidural Adhesiolysis Using Inflatable Balloon Catheter and Balloon-less Catheter in Central Lumbar Spinal Stenosis with Neurogenic Claudication: A Randomized Controlled Trial
2018
When conventional interventional procedures fail, percutaneous epidural adhesiolysis (PEA), which has moderate evidence for successful treatment of lumbar spinal stenosis (LSS), has been recommended over surgical treatments. In a previous study, we demonstrated the efficacy of a newly developed inflatable balloon catheter for overcoming the access limitations of pre-existing catheters for patients with severe stenosis or adhesions.
This study compared the treatment response of combined PEA with balloon decompression and PEA only in patients with central LSS over 6 months of follow-up.
This study used a randomized, single-blinded, active-controlled trial design.
This study took place in a single-center, academic, outpatient interventional pain management clinic.
This randomized controlled study included 60 patients with refractory central LSS who suffered from chronic lower back pain and/or lumbar radicular pain. Patients failed to maintain improvement for > 1 month with epidural steroid injection or PEA using a balloon-less catheter. Patients were randomly assigned to one of 2 interventions: balloon-less (n = 30) and inflatable balloon catheter (n = 30). The Numeric Rating Scale (NRS-11), Oswestry Disability Index (ODI), Global Perceived Effect of Satisfaction (GPES), and Medication Quantification Scale III were each measured at 1, 3, and 6 months after PEA.
There was a significant difference between groups in NRS-11 reduction ≥ 50% (or 4 points), ODI reduction ≥ 30% (or 10 points), GPES ≥ 6 and ≥ 4 points at 6 months, and NRS-11 reduction ≥ 50% (or 4 points) at 3 months after PEA (P < .03). The proportion of successful responders was higher in the balloon group than in the balloon-less group throughout the total follow-up period. Furthermore, there was a statistically significant difference between groups at 6 months after PEA (P = .035).
The results may vary according to the definition of successful response. Follow-up loss in the present study seemed to be high.
PEA using the inflatable balloon catheter leads to significant pain reduction and functional improvement compared to PEA using the balloon-less catheter in patients with central LSS.The study protocol was approved by our institutional review board (2012-0235), and written informed consent was obtained from all patients. The trial was registered with the Clinical Research Information Service (KCT 0002093).
Balloon decompression, central, chronic pain, epidural adhesiolysis, lumbar, percutaneous, radiculopathy, spinal stenosis.
Journal Article
Deviating colostomy construction versus stent placement as bridge to surgery for malignant left-sided colonic obstruction
2016
Background
Acute colonic decompression using a deviating colostomy (DC) or a self-expandable metal stent (SEMS) has been shown to lead to fewer complications and permanent stomas compared to acute resection in elderly patients with malignant left-sided colonic obstruction (LSCO). However, no consensus exists on which decompression method is superior, especially in patients treated with curative intend. This retrospective study therefore aimed to compare both decompression methods in potentially curable LSCO patients.
Methods
All LSCO patients treated with curative intent between 2004 and 2013 in two teaching hospitals were retrospectively identified. In one institution, a DC was the standard of care, whereas in the other all patients were treated with SEMS.
Results
In total, 88 eligible LSCO patients with limited disease and curative treatment options were included; 51 patients had a SEMS placed and 37 patients a DC constructed. All patients eventually underwent a subsequent elective resection. In sum, 235 patients were excluded due to benign or inoperable disease. No significant differences were found for hospital stay, morbidity, disease-free and overall survival and mortality. Major complications were seen in 13/51 (25.5 %) patients in the SEMS group and were mostly due to stent dysfunction (
n
= 7). Also, one stent-related perforation occurred. Major complications occurred in 4/37 (10.8 %) patients in the DC group, including abdominal sepsis (
n
= 3) and wound dehiscence (
n
= 1). Long-term complication rate was significantly higher in the DC group (29.7 vs. 9.8 %,
p
= 0.01), mainly due to a high incisional hernia rate. Fewer patients had a temporary colostomy following elective resection after SEMS placement (62.2 vs. 17.6 %,
p
< 0.01). Permanent colostomy rate was not significantly different.
Conclusion
SEMS and DC are both effective decompression methods for curable LSCO patients with comparable short- and long-term oncological outcomes; however, more surgical procedures are performed after DC due to an increased number of temporary colostomies and incisional hernia repairs.
Journal Article
The application of a new type of titanium mesh cage in hybrid anterior decompression and fusion technique for the treatment of continuously three-level cervical spondylotic myelopathy
by
Liu, Xiaowei
,
Xu, Bin
,
Li, Tiefeng
in
Cervical Vertebrae - surgery
,
Decompression, Surgical - instrumentation
,
Decompression, Surgical - methods
2017
Purpose
To evaluate the efficacy and safety of a new type of titanium mesh cage (NTMC) in hybrid anterior decompression and fusion method (HDF) in treating continuously three-level cervical spondylotic myelopathy (TCSM).
Methods
Ninety-four cases who had TCSM and accepted the HDF from Jan 2007 to Jan 2010 were included. Clinical and radiological outcomes were compared between cases who had the NTMC (Group A,
n
= 45) and traditional titanium mesh cage (TTMC, Group B,
n
= 49) after corpectomies. Each case accepted one polyetheretherketone cage (PEEK) after discectomy.
Results
Mean follow-up were 74.4 and 77.3 months in Group A and B, respectively (
p
> 0.05). Differences in cervical lordosis (CL), segmental lordosis (SL), anterior segmental height (ASH) and posterior segmental height (PSH) between two groups were not significant preoperatively, 3-days postoperatively or at final visit. However, losses of the CL, SL, ASH and PSH were all significantly larger in Group B at the final visit, so did incidences of segmental subsidence and severe subsidence. Difference in preoperative Japanese Orthopedic Association (JOA), visual analog scale (VAS), neck disability index (NDI) or SF-36 between two groups was not significant. At the final visit, fusion rate, JOA, and SF-36 were all comparable between two groups, but the VAS and NDI were both significantly greater in Group B.
Conclusions
For cases with TCSM, HDF with the NTMC and TTMC can provide comparable radiological and clinical improvements. But application of the NTMC in HDF is of advantages in decreasing the subsidence incidence, losses of lordosis correction, VAS and NDI.
Journal Article
Randomized Controlled Trial for Evaluation of the Routine Use of Nasogastric Tube Decompression After Elective Liver Surgery
2016
Background
The value of routine nasogastric tube (NGT) decompression after elective hepatetctomy is not yet established. Previous studies in the setting of non-liver abdominal surgery suggested that the use of NGT decreased the incidence of nausea or vomiting, while increasing the frequency of pulmonary complications.
Study Design
Out of a total of 284 consecutive patients undergoing hepatectomy, 210 patients were included in this study. The patients were randomized to a group that received NGT decompression (NGT group;
n
= 108), in which a NGT was left in place after surgery until the patient passed flatus or stool, or a group that did not receive NGT decompression (no-NGT group;
n
= 102), in which the NGT was removed at the end of surgery.
Results
There were no differences between the NGT group and no-NGT group in terms of the overall morbidity (34.3 vs 35.3 %;
P
= 0.99), incidence of pulmonary complications (18.5 vs 19.5 %;
P
= 0.84), frequency of postoperative vomiting (6.5 vs 7.8 %;
P
= 0.70), time to start of oral intake (median (range) 3 (2–6) vs 3 (2–6) days;
P
= 0.69), or postoperative duration of hospital stay (19 (7–74) vs 18 (9–186) days;
P
= 0.37). In the no-NGT group, three patients required reinsertion of the tube 0 (0–3) days after surgery. In the NGT group, severe discomfort was recorded in five patients.
Conclusions
Routine NGT decompression after elective hepatectomy does not appear to have any advantages.
Journal Article
Does an interspinous device (Coflex™) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients
by
Halm, Henry
,
Schütz, Christian
,
Hauck, Michael
in
Aged
,
Aged, 80 and over
,
Case-Control Studies
2010
A number of interspinous process devices have recently been introduced to the lumbar spinal market as an alternative to conventional surgical procedures in the treatment of symptomatic lumbar stenosis. One of those “dynamic” devices is the Coflex™ device which has been already implanted worldwide more than 14,000 times. The aim of implanting this interspinous device is to unload the facet joints, restore foraminal height and provide stability in order to improve the clinical outcome of surgery. Published information is limited, and there are so far no data of comparison between the implant and traditional surgical approaches such as laminotomy. The purpose of our prospective study is to evaluate the surgical outcome of decompressive surgery in comparison to decompressive surgery and additional implantation of the Coflex™ interspinous Device. 60 patients who were all treated in the Spine Center of Klinikum Neustadt, Germany for a one or two level symptomatic LSS with decompressive surgery were included. Two groups were built. In Group one (UD) we treated 30 patients with decompression surgery alone and group two (CO) in 30 patients a Coflex™ device was additional implanted. Pre- and postoperatively disability and pain scores were measured using the Oswestry disability index (ODI), the Roland–Morris score (RMS), the visual analogue scale (VAS) and the pain-free walking distance (WD). Patients underwent postoperative assessments 3, 6 and 12 month including the above-mentioned scores as well as patient satisfaction. In both groups we could see a significant improve (
p
< 0.001) in the clinical outcome assessed in the ODI, in the RMS for evaluation of back pain, in the VAS and in the pain-free WD at all times of reinvestigation compared to base line. At 1-year follow up there were no statistically differences between both groups in all ascertained parameters including patient satisfaction and subjective operation decision. Because there is no current evidence of the efficacy of the Coflex™ device we need further data from randomized controlled studies for defining the indications for theses procedures. To the best of our knowledge this is the first prospective controlled study which compares surgical decompression of lumbar spinal stenosis with additional implanting of an interspinous Coflex™ device in the treatment of symptomatic LSS.
Journal Article
Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial
by
van den Akker-van Marle, M Elske
,
Peul, Wilco C
,
Arts, Mark P
in
Aged
,
Aged, 80 and over
,
Back
2013
Objective To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis. Design Randomized controlled trial. Setting Five neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands. Participants 203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized. Interventions 80 participants received an interspinous process device and 79 participants underwent spinal bony decompression. Main outcome measures The primary outcome at short term (eight weeks) and long term (one year) follow-up was the Zurich Claudication Questionnaire score. Repeated measurements were made to compare outcomes over time. Results At eight weeks, the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for standard bony decompression (72%, 60% to 81%). No differences in disability (Zurich Claudication Questionnaire; P=0.44) or other outcomes were observed between groups during the first year. The repeat surgery rate in the interspinous implant group was substantially higher (n=21; 29%) than that in the conventional group (n=6; 8%) in the early post-surgical period (P<0.001). Conclusions This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional “simple” decompression and even showed a fairly high reoperation rate after interspinous process device implantation. Trial registration Dutch Trial Register NTR1307.
Journal Article
Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis
by
Nunley, Pierce D.
,
Geisler, Fred H.
,
Shamie, A. Nick
in
Back
,
Back Pain - surgery
,
Biomedical research
2016
Interspinous process decompression is a minimally invasive implantation procedure employing a stand-alone interspinous spacer that functions as an extension blocker to prevent compression of neural elements without direct surgical removal of tissue adjacent to the nerves. The Superion® spacer is the only FDA approved stand-alone device available in the US. It is also the only spacer approved by the CMS to be implanted in an ambulatory surgery center. We computed the within-group effect sizes from the Superion IDE trial and compared them to results extrapolated from two randomized trials of decompressive laminectomy. For the ODI, effect sizes were all very large (>1.0) for Superion and laminectomy at 2, 3, and 4 years. For ZCQ, the 2-year Superion symptom severity (1.26) and physical function (1.29) domains were very large; laminectomy effect sizes were very large (1.07) for symptom severity and large for physical function (0.80). Current projections indicate a marked increase in the number of patients with spinal stenosis. Consequently, there remains a keen interest in minimally invasive treatment options that delay or obviate the need for invasive surgical procedures, such as decompressive laminectomy or fusion. Stand-alone interspinous spacers may fill a currently unmet treatment gap in the continuum of care and help to reduce the burden of this chronic degenerative condition on the health care system.
Journal Article
Does Wallis implant reduce adjacent segment degeneration above lumbosacral instrumented fusion?
by
Zacharatos, Spyros
,
Zafiropoulos, Andreas
,
Repantis, Thomas
in
Adult
,
Aged
,
Decompression, Surgical - instrumentation
2009
Delayed complications following lumbar spine fusion may occur amongst which is adjacent segment degeneration (ASD). Although interspinous implants have been successfully used in spinal stenosis to authors’ knowledge such implants have not been previously used to reduce ASD in instrumented lumbar fusion. This prospective controlled study was designed to investigate if the implantation of an interspinous implant cephalad to short lumbar and lumbosacral instrumented fusion could eliminate the incidence of ASD and subsequently the related re-operation rate. Groups W and C enrolled initially each 25 consecutive selected patients. Group W included patients, who received the Wallis interspinous implant in the unfused vertebral segment cephalad to instrumentation and the group C selected age-, diagnosis-, level-, and instrumentation-matched to W group patients without interspinous implant (controls). The inclusion criterion for Wallis implantation was UCLA arthritic grade UCLA grade II in the adjacent two segments cephalad to instrumentation. All patients suffered from symptomatic spinal stenosis and underwent decompression and 2–4 levels stabilization with rigid pedicle screw fixation and posterolateral fusion by a single surgeon. Lumbar lordosis, disc height (DH), segmental range of motion (ROM), and percent olisthesis in the adjacent two cephalad to instrumentation segments were measured preoperatively, and postoperatively until the final evaluation. VAS, SF-36, and Oswestry Disability Index (ODI) were used. One patient of group W developed pseudarthrosis: two patients of group C deep infection and one patient of group C ASD in the segment below instrumentation and were excluded from the final evaluation. Thus, 24 patients of group W and 21 in group C aged 65+ 13 and 64+ 11 years, respectively were included in the final analysis. The follow-up averaged 60 ± 6 months. The instrumented levels averaged 2.5 + 1 vertebra for both groups. All 45 spines showed radiological fusion 8–12 months postoperatively. Lumbar lordosis did not change postoperatively. Postoperatively at the first cephalad adjacent segment: DH increased in the group W (
P
= 0.042); ROM significantly increased only in group C (ANOVA,
P
< 0.02); olisthesis decreased both in flexion (
P
= 0.0024) and extension (
P
= 0.012) in group W. The degeneration or deterioration of already existed ASD in the two cephalad segments was shown in 1 (4.1%) and 6 (28.6%) spines in W and C groups, respectively. Physical function (SF-36) and ODI improved postoperatively (
P
< 0.001), but in favour of the patients of group W (
P
< 0.05) at the final evaluation. Symptomatic ASD required surgical intervention was in 3 (14%) patients of group C and none in group W. ASD remains a significant problem and accounts for a big portion of revision surgery following instrumented lumbar fusion. In this series, the Wallis interspinous implant changed the natural history of ASD and saved the two cephalad adjacent unfused vertebra from fusion, while it lowered the radiographic ASD incidence until to 5 years postoperatively. Longer prospective randomized studies are necessary to prove the beneficial effect of the interspinous implant cephalad and caudal to instrumented fusion. We recommend Wallis device for UCLA degeneration I and II.
Journal Article
Using Augmented Reality as a Clinical Support Tool to Assist Combat Medics in the Treatment of Tension Pneumothoraces
by
Wilson, Kenneth L.
,
Fashola, Olatokunbo S.
,
Danner, Omar K.
in
Amputation
,
Augmented reality
,
Cadaver
2013
This study was to extrapolate potential roles of augmented reality goggles as a clinical support tool assisting in the reduction of preventable causes of death on the battlefield. Our pilot study was designed to improve medic performance in accurately placing a large bore catheter to release tension pneumothorax (prehospital setting) while using augmented reality goggles. Thirty-four preclinical medical students recruited from Morehouse School of Medicine performed needle decompressions on human cadaver models after hearing a brief training lecture on tension pneumothorax management. Clinical vignettes identifying cadavers as having life-threatening tension pneumothoraces as a consequence of improvised explosive device attacks were used. Study group (n = 13) performed needle decompression using augmented reality goggles whereas the control group (n = 21) relied solely on memory from the lecture. The two groups were compared according to their ability to accurately complete the steps required to decompress a tension pneumothorax. The medical students using augmented reality goggle support were able to treat the tension pneumothorax on the human cadaver models more accurately than the students relying on their memory (p < 0.008). Although the augmented reality group required more time to complete the needle decompression intervention (p = 0.0684), this did not reach statistical significance.
Journal Article
Results of a Prospective Randomized Study Comparing a Novel Retractor With a Caspar Retractor in Anterior Cervical Surgery
by
SEEX, Kevin A
,
PATTAVILAKOM, Ananthababu
in
Biological and medical sciences
,
Cervical Vertebrae - surgery
,
Decompression, Surgical - instrumentation
2011
Retraction injury might explain the soft tissue complications seen after anterior cervical surgery. A novel retractor system (Seex retractor system [SRS]) that uses a principle of bone fixation with rotation has been shown to reduce retraction pressure in a cadaveric model of anterior cervical decompression and fusion.
To compare the conventional Cloward-style retractor (CRS) with the SRS in a prospective randomized clinical trial.
After ethics and study registration (ACTRN 12608000430336), eligible patients were randomized to either the CRS or SRS before 1- or 2-level anterior cervical decompression and fusion. The pressure beneath the medial retractor blade was recorded with a thin pressure transducer strip. Postoperative sore throat, dysphagia, and dysphonia were assessed after 1, 7, and 28 days.
Twenty-six patients were randomized. There were no serious complications. Complication rates were low with a trend favoring SRS that was not statistically different. Average retraction pressure with SRS was 1.9 mm Hg and with CRS was 5.6 mm Hg (P < .001 on F test; P = .002 on 2-tailed t test). Mean average peak retraction pressure with the SRS was 3.4 mm Hg and with the CRS was 20 mm Hg (P < .001 on F test; P = .005 on 2-tailed t test).
The new retractor is safe, and statistically similar complication rates were observed with the 2 systems. The SRS generated significantly less retraction pressure compared with the CRS. This difference can be explained by the different principles governing the function of these retractors. Bone fixation gives stability and rotation reduces tissue pressure, both desirable in a retractor.
Journal Article