Symptomatic Rathke cleft cysts: extent of resection and surgical complications

2011 ◽  
Vol 31 (1) ◽  
pp. E2 ◽  
Author(s):  
Dominique M. Higgins ◽  
Jamie J. Van Gompel ◽  
Todd B. Nippoldt ◽  
Fredric B. Meyer
Keyword(s):  
Surgical Complications ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Extent Of Resection ◽  
Primary Outcome Measure ◽  
Gross Total Resection ◽  
Total Resection ◽  
Repeat Surgery ◽  
The Mean ◽  
Operative Notes

Object Rathke cleft cysts (RCCs) are benign masses arising from the embryological Rathke pouch, and are commonly treated by transsphenoidal surgery. The authors retrospectively compared RCC extent of resection—either gross-total resection (GTR) or decompression—to the primary outcome measure, which was recurrences resulting in repeat surgery, and the secondary outcome measure, which was complications. Methods Seventy-four patients presenting to the neurosurgical department with RCC were analyzed retrospectively. Sixty-eight patients had a total of 78 surgical procedures, with the diagnosis of RCC confirmed by histological investigation; of these, 61 patients had adequate operative notes for the authors to evaluate extent of resection. Groups were separated into GTR (32 patients) or decompression (subtotal resection or fenestration into the sphenoid sinus; 29 patients) based on operative notes and postoperative imaging. The mean follow-up duration was 60.5 ± 72.1 months (the mean is expressed ± SD throughout). Results The average age at the time of the initial surgery was 42.8 ± 17.4 years, and 70% of patients were female. The mean cyst diameter preoperatively was 16.9 ± 17.8 mm. Eight patients had repeat surgery, our primary outcome measure; 3 repeat operations occurred in the GTR group, and 5 in the decompression group. There was no significant difference in recurrence when comparing groups (GTR 9%, decompression 17%; p = 0.36). There were no major complications; however, analysis of postoperative minor complications revealed that 11 (34%) GTRs resulted in surgical complications, whereas the decompression cohort accounted for only 3 complications (10%) (p = 0.03), with diabetes insipidus (6) and CSF leaks (5) being the most common. Gross-total resection also resulted in an increase in postoperative hyperprolactinemia compared with decompression (p = 0.03). Conclusions It appears that RCCs require repeat surgery in 13% of cases, and attempted GTR does not appear to reduce the overall rate of recurrence. However, more aggressive resections are associated with more complications in this series.

A phase III trial of intramuscular recombinant interferon beta as treatment for exacerbating-remitting multiple sclerosis: design and conduct of study and baseline characteristics of patients

1995 ◽  
Vol 1 (2) ◽  
pp. 118-135 ◽  
Author(s):  
LD Jacobs ◽  
DL Cookfair ◽  
RA Rudick ◽  
RM Herndon ◽  
J R Richert ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Interferon Beta ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Recombinant Interferon ◽  
Study Population ◽  
The Mean ◽  
Baseline Characteristics

The design and conduct of a randomized, double-blinded, placebo-controlled, multicenter, phase III study of recombinant interferon beta-1a (IFN-β-1a) as treatment for exacerbating-remitting MS are described, as are baseline characteristics of the study population. The purpose of the study was to determine if 6.0 × 106 IU (30 μg) of IFN-β-1a, administered by weekly intramuscular (i.m.) injections, was effective in delaying the onset of sustained disability. The primary outcome measure was time to onset of treatment failure, defined as a worsening on the Kurtzke Expanded Disability Status Scale (EDSS) of greater than or equal to 1.0 point compared with baseline, persisting for at least 6 months. An intent-to-treat design was used. The primary outcome measure was analyzed using the Mantel-Cox log-rank statistic and Kaplan-Meier survival curves. Secondary outcomes included quantitative measures of upper and lower extremity function, neuropsychological test performance, functional and quality of life assessments and several measures derived from annual brain MRI studies. Entry criteria included prestudy exacerbation rates of at least 0.67 per year and EDSS scores of 1.0–3.5. A total of 301 MS patients were randomly assigned to receive weekly i.m. injections of IFN-β-1a or placebo. The average age of the study population at entry was 37 years; 92% were Caucasian and 73% were women. The mean prestudy disease duration was 6.5 years, mean prestudy exacerbation rate was 1.2 per year and the mean EDSS score was 2.3. The randomization yielded well-balanced treatment arms. Various aspects of the study are discussed, including: (1) the decision to focus study design on sustained disability; (2) the rationale for the treatment regimen; (3) measures taken to assure the reliability of the primary outcome measure; and (4) a description of the secondary outcome measures.

Endoscopic endonasal surgery for nonadenomatous, nonmeningeal pathology involving the cavernous sinus

2017 ◽  
Vol 126 (3) ◽  
pp. 880-888 ◽  
Author(s):  
Aikaterini Patrona ◽  
Kunal S. Patel ◽  
Evan D. Bander ◽  
Alpesh Mehta ◽  
Apostolos John Tsiouris ◽  
...  
Keyword(s):  
Cavernous Sinus ◽  
Pituitary Adenomas ◽  
Extent Of Resection ◽  
Gross Total Resection ◽  
Tumor Board ◽  
Benign Tumors ◽  
Total Resection ◽  
Cranial Neuropathies ◽  
The Mean ◽  
Underlying Pathology

OBJECTIVE Surgery within the cavernous sinus (CS) remains a controversial topic because of the delicate and complex anatomy. The risk also varies with tumor consistency. Softer tumors such as pituitary adenomas are more likely to be surgically treated, while firm tumors such as meningiomas are often treated with radiosurgery. However, a wide range of pathologies that can involve the CS are amenable to surgery. The authors describe and analyze their results using endonasal endoscopic “medial-to-lateral” approaches for nonadenomatous, nonmeningeal tumors, in relation to the degree of invasion within the CS. METHODS A prospectively acquired database of consecutive endoscopic approaches for tumors with verified intraoperative CS invasion was reviewed. Pituitary adenomas and meningiomas were excluded. Degree of invasion of the CS was classified using the Knosp-Steiner (KS) grading system as well as the percentage of cavernous carotid artery (CCA) encasement. Extent of resection of the entire tumor and of the CS component was assessed by independent neuroradiologists using volumetric measurements of the pre- and postoperative MRI studies. Demographic data and complications were noted. RESULTS Fifteen patients (mean age 51.1 years who received endoscopic surgery between 2007 and 2013 met the selection criteria. There were 11 malignant tumors, including chordoma, chondrosarcoma, hemangiopericytoma, lymphoma, and metastatic cancer, and 4 benign tumors, including 3 cavernous hemangiomas and 1 dermoid. All cases were discussed before treatment in a tumor board. Adjuvant treatment options included chemotherapy and radiotherapy. The mean pre- and postoperative tumor volumes were 12.74 ml and 3.86 ml. Gross-total resection (GTR; ie, resection greater than 95%) was the goal in 13 cases and was achieved in 6 patients (46%) while in addition 5 patients had a greater than 80% resection. Gross-total resection in the CS was accomplished in 55% of the tumors with KS Grades 1–2 and in 16.6% of the tumors with KS grades 3–4, respectively. Likewise, GTR was accomplished in 55% of the tumors with CCA encasement under 75% and in 14.3% of the lesions with CCA encasement over 75%, irrespective of tumor volume and underlying pathology. There were 18 preexisting cranial neuropathies involving cranial nerves III–VI, of which 9 fully resolved, 4 improved, and 3 remained unchanged; 2 of these worsened with tumor recurrence. Surgical complications included 1 transient new cranial nerve VI palsy associated with Horner's syndrome and 1 case of panhypopituitarism. There were no postoperative CSF leaks and no infections. The mean extended follow-up was 34.4 months. CONCLUSIONS Endonasal endoscopic approaches can play a role in the management of nonmeningeal, nonadenomatous tumors invading the CS, either through biopsy, debulking, or GTR. An advantage of this method is the relief of preexisting cranial neuropathies with low risk for new neurological deficit. Extent of resection within the CS varies with KS grade and degree of carotid encasement irrespective of the underlying pathology. The goals of surgery should be clearly established preoperatively in consultation with radiation and medical oncologists.

scholarly journals A Sternum-Disk Distance Method to Identify the Skin Level for Approaching a Surgical Segment without Fluoroscopy Guidance during Anterior Cervical Discectomy And Fusion

2017 ◽  
Vol 11 (1) ◽  
pp. 50-56
Author(s):  
Gun Woo Lee ◽  
Myun-Whan Ahn ◽  
Ji-Hoon Shin ◽  
Jae Woo Park ◽  
Jae-Hyung Uh ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Kappa Coefficient ◽  
Anterior Cervical Discectomy ◽  
Secondary Outcome ◽  
Distance Method ◽  
Cervical Discectomy ◽  
Observer Reliability ◽  
The Mean

<sec><title>Study Design</title><p>A retrospective review of prospectively collected data.</p></sec><sec><title>Purpose</title><p>To introduce the sternum-disk distance (SDD) method for approaching the exact surgical level without C-arm guidance during anterior cervical discectomy and fusion (ACDF) surgery and to evaluate its accuracy and reliability.</p></sec><sec><title>Overview of Literature</title><p>Although spine surgeons have tried to optimize methods for identifying the skin level for accessing the operative disk level without C-arm guidance during ACDF, success has rarely been reported.</p></sec><sec><title>Methods</title><p>In total, 103 patients who underwent single-level ACDF surgery with the SDD method were enrolled. The primary outcome measure was the accuracy of the SDD method. The secondary outcome measures were the mean SDD value at each cervical level from the cranial margin of the sternum in the neutral and extension positions of the cervical spine and the inter- and intra-observer reliability of the SDD outcome determined using repeated measurements by three orthopedic spine surgeons.</p></sec><sec><title>Results</title><p>The SDD accuracy (primary outcome measure) was indicated in 99% of the patients (102/103). The mean SDD values in the neutral-position magnetic resonance imaging (MRI) were 108.8 mm at C3–C4, 85.3 mm at C4–C5, 64.4 mm at C5–C6, 44.3 mm at C6–C7, and 24.1 mm at C7–T1; and those in the extension-position MRI were 112.9 mm at C3–C4, 88.7 mm at C4–C5, 67.3 mm at C5–C6, 46.5 mm at C6–C7, and 24.3 mm at C7–T1. The Cohen kappa coefficient value for intra-observer reliability was 0.88 (excellent reliability), and the Fleiss kappa coefficient value for inter-observer reliability as reported by three surgeons was 0.89 (excellent reliability).</p></sec><sec><title>Conclusions</title><p>Based on the results of the present study, we recommend performing ACDF surgery using the SDD method to determine the skin level for approaching the surgical cervical segment without fluoroscopic guidance.</p></sec>

The rate of successful four-corner arthrodesis with a locking, dorsal circular polyether-ether-ketone (PEEK-Optima) plate

2013 ◽  
Vol 38 (7) ◽  
pp. 767-773 ◽  
Author(s):  
P. C. Rhee ◽  
A. Y. Shin
Keyword(s):  
Circular Plate ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Accurate Assessment ◽  
Polyether Ether Ketone ◽  
The Mean ◽  
Ether Ketone ◽  
Mean Time

The purpose of this study is to evaluate the rate of union after four-corner arthrodesis with a locking, dorsal circular plate comprised of polyether-ether-ketone. A retrospective review was conducted of all patients who underwent four-corner arthrodesis with a locking, dorsal circular plate at our institution from January 2005 to May 2009. The primary outcome measure was radiographic and clinical union. During the study period, 26 consecutive wrists underwent four-corner arthrodesis with a locking, dorsal circular plate. Twenty-three wrists were included. The mean clinical follow-up was 16 months (range 3–37). Union was achieved in 22 of 23 wrists at a mean time of 3 months (range 1–12). There was one partial union that underwent successful revision arthrodesis. In summary, four-corner fusion with a polyether-ether-ketone locking, dorsal circular plate results in high union rates. The use of a radiolucent plate allows for more accurate assessment of union with the biomechanical advantages of a fixed angle construct.

scholarly journals Estimates of the mean difference in orthopaedic randomized trials: obligatory yet obscure

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lauri Raittio ◽  
Antti Launonen ◽  
Ville M. Mattila ◽  
Aleksi Reito
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Patient Reported Outcome ◽  
Ceiling Effect ◽  
Mean Difference ◽  
Discussion Section ◽  
Power Calculations ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Mean

Abstract Background Randomized controlled trials in orthopaedics are powered to mainly find large effect sizes. A possible discrepancy between the estimated and the real mean difference is a challenge for statistical inference based on p-values. We explored the justifications of the mean difference estimates used in power calculations. The assessment of distribution of observations in the primary outcome and the possibility of ceiling effects were also assessed. Methods Systematic review of the randomized controlled trials with power calculations in eight clinical orthopaedic journals published between 2016 and 2019. Trials with one continuous primary outcome and 1:1 allocation were eligible. Rationales and references for the mean difference estimate were recorded from the Methods sections. The possibility of ceiling effect was addressed by the assessment of the weighted mean and standard deviation of the primary outcome and its elaboration in the Discussion section of each RCT where available. Results 264 trials were included in this study. Of these, 108 (41 %) trials provided some rationale or reference for the mean difference estimate. The most common rationales or references for the estimate of mean difference were minimal clinical important difference (16 %), observational studies on the same subject (8 %) and the ‘clinical relevance’ of the authors (6 %). In a third of the trials, the weighted mean plus 1 standard deviation of the primary outcome reached over the best value in the patient-reported outcome measure scale, indicating the possibility of ceiling effect in the outcome. Conclusions The chosen mean difference estimates in power calculations are rarely properly justified in orthopaedic trials. In general, trials with a patient-reported outcome measure as the primary outcome do not assess or report the possibility of the ceiling effect in the primary outcome or elaborate further in the Discussion section.

scholarly journals Clinical impact of left and right axis deviations with narrow QRS complex on 3-year outcomes in a hospital-based population in Japan

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yuta Seko ◽  
Takao Kato ◽  
Yuhei Yamaji ◽  
Yoshisumi Haruna ◽  
Eisaku Nakane ◽  
...  
Keyword(s):  
Cardiovascular Events ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Conduction Block ◽  
Primary Outcome Measure ◽  
Excess Risk ◽  
Major Adverse Cardiovascular Events ◽  
Prognostic Impact ◽  
Axis Deviation ◽  
The Right

AbstractWhile the prognostic impact of QRS axis deviation has been assessed, it has never been investigated in patients without conduction block. Thus, we evaluated the prognostic impact of QRS-axis deviation in patients without conduction block. We retrospectively analyzed 3353 patients who had undergone both scheduled transthoracic echocardiography and electrocardiography in 2013 in a hospital-based population, after excluding patients with a QRS duration of ≥ 110 ms, pacemaker placement, and an QRS-axis − 90° to − 180° (northwest axis). The study population was categorized into three groups depending on the mean frontal plane QRS axis as follows: patients with left axis deviation (N = 171), those with right axis deviation (N = 94), and those with normal axis (N = 3088). The primary outcome was a composite of all-cause death and major adverse cardiovascular events. The cumulative 3-year incidence of the primary outcome measure was significantly higher in the left axis deviation group (26.4% in the left axis deviation, 22.7% in the right axis deviation, and 18.4% in the normal axis groups, log-rank P = 0.004). After adjusting for confounders, the excess risk of primary outcome measure remained significant in the left axis deviation group (hazard ratio [HR] 1.44; 95% confidence interval [CI] 1.07–1.95; P = 0.02), while the excess risk of primary outcome measure was not significant in the right axis deviation group (HR 1.22; 95% CI 0.76–1.96; P = 0.41). Left axis deviation was associated with a higher risk of a composite of all-cause death and major adverse cardiovascular events in hospital-based patients without conduction block in Japan.

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

scholarly journals Profound hearing loss following surgery in pediatric patients with posterior fossa low-grade glioma

2017 ◽  
Vol 5 (2) ◽  
pp. 96-103 ◽  
Author(s):  
Yahya Ghazwani ◽  
Ibrahim Qaddoumi ◽  
Johnnie K Bass ◽  
Shengjie Wu ◽  
Jason Chiang ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Posterior Fossa ◽  
Extent Of Resection ◽  
Tumor Location ◽  
Low Grade Glioma ◽  
Gross Total Resection ◽  
Subtotal Resection ◽  
Low Grade ◽  
Total Resection ◽  
Profound Hearing Loss

Abstract Background Hearing loss may occur in patients with posterior fossa low-grade glioma who undergo surgery. Methods We retrospectively reviewed 217 patients with posterior fossa low-grade glioma, including 115 for whom results of hearing tests performed after surgery and before chemotherapy or radiation therapy were available. We explored the association of UHL with age at diagnosis, sex, race, tumor location, extent of resection, posterior fossa syndrome, ventriculoperitoneal shunt placement, and histology. Results Of the 115 patients, 15 (13.0%: 11 male, 6 black, 8 white, 1 multiracial; median age 7 years [range, 1.3–17.2 years]) had profound UHL after surgery alone or before receiving ototoxic therapy. Median age at tumor diagnosis was 6.8 years (range, 0.7–14.1 years), and median age at surgery was 6.8 years (range, 0.7–14.1 years). Patients with UHL had pathology characteristic of pilocytic astrocytoma (n = 10), ganglioglioma (n = 4), or low-grade astrocytoma (n = 1). Of these 15 patients, 4 underwent biopsy, 1 underwent gross total resection, 1 underwent near-total resection, and 9 underwent subtotal resection. UHL was more frequent in black patients than in white patients (OR 7.3, P = .007) and less frequent in patients who underwent gross total resection or near-total resection than in those who underwent subtotal resection (OR 0.11, P = .02). Conclusions Children undergoing surgery for posterior fossa low-grade glioma are at risk for UHL, which may be related to race or extent of resection. These patients should receive postoperative audiologic testing, as earlier intervention may improve outcomes.

scholarly journals Extent of resection in glioblastoma: a 10-year local survival analysis

2021 ◽  
Vol 23 (Supplement_4) ◽  
pp. iv19-iv19
Author(s):  
Theodore Hirst ◽  
Patrick McAleavey ◽  
Tom Flannery
Keyword(s):  
Neurological Deficit ◽  
Survival Benefit ◽  
Extent Of Resection ◽  
Cox Proportional Hazards ◽  
Partial Resection ◽  
Gross Total Resection ◽  
Molecular Profile ◽  
Total Resection ◽  
Local Survival ◽  
The Impact

Abstract Aims The impact on extent of resection (EOR) in glioblastoma has been well documented. It is clear that gross-total resection (GTR) confers best overall survival (OS), however the minimum EOR required to confer a survival benefit over biopsy is debated. Recent studies favour partial resection (PR) over biopsy for IDH-wildtype, MGMT-unmethylated tumours. We describe our experiences locally with these principles in mind. Method Retrospective evaluation of a single surgeon cohort. All patients over 18 years old, undergoing a surgical treatment for histologically confirmed GBM in the stated period were included. We collected information on demographics, tumour volume, EOR, complications, adjuvant therapies, molecular profile, and OS. We used log rank tests and Cox Proportional Hazards Models to identify factors associated with OS. Results The patient and tumour characteristics of our cohort were similar to those documented in the literature. The mean age was 56.6 years. 72 patients underwent biopsy and 202 had debulking surgery. Median OS was 11 months. Of those debulked, gross-total resection was achieved in 41 patients (20%); associated median OS was 29 months. Patients receiving partial resection (defined as EOR &lt;80%) had no clear survival benefit over patients undergoing biopsy (median OS 6 vs 5 months) but had a higher rate of post-op neurological deficit (3% vs 12%). Tumour molecular profile appeared to influence survival outcome in a manner comparable to worldwide experience. Conclusion In our experience, partial resection is not a justifiable surgical aim in the typical glioblastoma cohort. The limited benefit that it may confer over biopsy appears to be outweighed by the risk of neurological deficit that affects quality and probably quantity of life. This finding applies to our glioblastoma population in general as well as those specifically with an MGM-unmethylated tumour.

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