Implantable Agents for Fecal Incontinence: An Age-Matched Retrospective Cohort Analysis of GateKeeper versus SphinKeeper

Background. We aim to evaluate morphofunctional changes of the sphincter complex after GateKeeper (GK) and SphinKeeper (SK) procedures and correlate these with symptom improvement. Methods. Ten consecutive females undergoing SK implant were age-matched with a cohort of 10 females who previously underwent the GK procedure. Patients in the SK and GK groups underwent implantation of 10 and 6 prostheses, respectively. Muscle tension ( Tm), expressed in millinewtons per centimetre squared, mN (cm2)−1, was calculated using the equation Tm = P( r i)( tm)−1, where P is the average maximum squeeze pressure and r i and tm the inner radius and thickness of the external anal sphincter, respectively. The pre- and postimplant changes in Tm and Cleveland Clinic Fecal Incontinence Score (CCFIS) were tested by linear and Poisson regression models, respectively. Results. The CCFIS significantly improved in both groups at 12-month postimplantation. Although not reaching statistical significance, symptom improvement after SK was 33% above that observed after GK ( P = .088). Compared to the baseline, a significant increase in Tm was observed in both groups at 12 months (GK, 508.1 [478.8-568.0] vs 864.4 [827.0-885.8] mN (cm2)−1; SK, 528.0 [472.7-564.0] vs 858.6 [828.0-919.6] mN (cm2)−1, P = .005). Compared to the GK group, Tm was significantly higher in patients after SK implant (158.3 mN (cm2)−1 [95% confidence interval, 109.6-207.0]; P < .001), after controlling for baseline values, at 12-month postimplantation. Conclusions. GK and SK are safe and effective treatments for FI with good short-term clinical outcomes. Comparative analysis showed superiority of SK over GK in terms of gain in Tm, with borderline significantly better improvement in symptoms. Larger studies are needed to confirm these findings.

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Gatekeeper Improves Voluntary Contractility in Patients With Fecal Incontinence

Surgical Innovation ◽

10.1177/1553350618818924 ◽

2018 ◽

Vol 26 (3) ◽

pp. 321-327 ◽

Cited By ~ 4

Author(s):

Ugo Grossi ◽

Veronica De Simone ◽

Angelo Parello ◽

Francesco Litta ◽

Lorenza Donisi ◽

...

Keyword(s):

Maximum Likelihood ◽

Fecal Incontinence ◽

Muscle Tension ◽

Cleveland Clinic ◽

Restricted Maximum Likelihood ◽

Medical Systems ◽

Squeeze Pressure ◽

Inner Radius ◽

Average Maximum ◽

Before And After

Background. Gatekeeper (GK) has shown to be safe and effective in patients with fecal incontinence (FI). We aimed to understand its mechanism of action by comparing pre- and post-implant change in the external anal sphincter (EAS) contractility. Methods. Study of EAS contractility was conducted in 16 FI females (median age = 69 years) before and after implant of 6 GK prostheses. Muscle tension ( Tm), expressed in millinewtons per centimeter squared, mN(cm2)−1, was calculated using the equation Tm = P(ri)(tm)−1, where P is the average maximum squeeze pressure and ri and tm the inner radius and thickness of the EAS, respectively. The effect of a predefined set of covariates on Tm was tested by restricted maximum likelihood models. Results. Compared with baseline, despite unchanged tm (2.7 [2.5-2.8] vs 2.5 [2.2-2.8] mm; P = .31 mm), a significant increase in P (median = 45.8 [26.5-75.8] vs 60.4 [43.1-88.1] mm Hg; P = .017), and ri (12.4 [11.5-13.4] vs 18.7 [17.3-19.6] mm; P < .001) resulted in an increase in Tm (233.2 [123.8-303.2] vs 490.8 [286.9-562.4] mN(cm2)−1; P < .001) at 12 months after GK implant. Twelve-month follow-up improvements were also observed on Cleveland Clinic FI score (8-point median decrease; P = .0001), St Marks FI score (10-point median decrease; P < .0001), and American Medical Systems score (39-point median decrease; P < .0001). Restricted maximum likelihood models showed that years of onset of FI was negatively associated with change in Tm ( P = .048). Conclusions. GK-related EAS compression positively influences muscle contractility by increasing ri, with consequent increase in Tm (length-tension relationship). Further studies are needed to confirm the long-term effectiveness of GK.

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Therapeutic Effect of Changqiang Acupoint Injection on Children with Functional Fecal Incontinence

Acupuncture & Electro-Therapeutics Research ◽

10.3727/036012921x16298112109466 ◽

2021 ◽

Author(s):

Changying Yi ◽

Jie Zhang ◽

Meili Fan

Keyword(s):

Treatment Group ◽

Fecal Incontinence ◽

Cleveland Clinic ◽

Control Group ◽

Incontinence Score ◽

Randomized Controlled Clinical Trials ◽

Randomized Controlled ◽

Stool Incontinence ◽

Acupoint Injection ◽

Significant Difference

Objective: Functional fecal incontinence in children (FFIC), also known as functional fecal disorder in children, is a type of childhood diseases characterized by excretory dysfunction. In the study, we observed the clinical effect of Changqiang acupoint injection on functional fecal incontinence in children (FFIC) by randomized controlled clinical trials. Materials and methods: 140 children with functional fecal incontinence who met the screening criteria were respectively assigned into the treatment group (100 cases) and the control group (40 cases) according to the completely randomized controlled design. In the treatment group, Chuankezhi injection was administrated at the Changqiang acupoint once a week for three weeks (one course of treatment). In contrast, the subjects in the control group was instructed to receive sphincter exercise and defecation training, followed by an assessment on the therapeutic efficacy after one course of treatment. Results: The overall response rate of the two groups was 93.00% (93/100) and 57.50% (23/40), respectively, with a statistically significant difference (P<0.01). The treatment group showed a performance superior to the control group based on the Cleveland Clinic Florida Fecal Incontinence Score System (CCF-FI)—dry stool incontinence, liquid incontinence, gas incontinence, lifestyle change, necessity of using pads or antidiarrheals, the ability to delay defecation, and the total score. The inter-group comparison revealed a statistically significant difference (P<0.01). Conclusion:Changqiang acupoint injection has significant curative effect on FFIC as demonstrated by significant relief in the symptoms associated with fecal incontinence, and thus is considered as a useful approach to be widely applied in clinical practice.

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Appendicostomy Antegrade Colonic Irrigation by Electromechanical Pump, a Novel Method for Managing Fecal Incontinence, Randomized Clinical Trial

ACTA MEDICA IRANICA ◽

10.18502/acta.v57i4.1840 ◽

2019 ◽

Author(s):

Seyed Hamzeh Mousavie ◽

Rezvan Mirzaei ◽

Bahar Mahjoubi ◽

Amir Nahavandi

Keyword(s):

Clinical Trial ◽

Fecal Incontinence ◽

Traditional Method ◽

Cleveland Clinic ◽

Colonic Irrigation ◽

Incontinence Score ◽

Cord Injury ◽

Speed Up ◽

Novel Method ◽

Colon Irrigation

Antegrade colonic irrigation enema (ACIE) is established as an old treatment for child fecal incontinence and recently is approved as a treatment for different causes of adult fecal incontinence (cancer surgery, neurogenic bowel, spinal cord injury, sphincter trauma, etc.). Despite the benefits of emptying the large bowel and prevention of fecal incontinence or constipation, this method is time-consuming and requires thorough instruction and training. The purpose of this study was to innovate and assess novel technique to decrease time-consuming and improve performance of irrigation. We designed and electromechanical pump for colon irrigation and assessed by a randomized crossover clinical trial study, involving two-four weeks treatment phases. 30 patients have included that suffered fecal incontinence and had been managed with appendicostomy antegrade colon irrigation. The results showed that the pump decrease time and volume of irrigation compare with the traditional method. All patients had a reduction in toileting times. Traditional mean toileting time was 67 minutes, versus pump-toileting time that was 24.6 minutes (P:0.00). The volume of water was reduced in 13 patients. Mean of the volume was 1712 ml in the traditional method and 1128 ml in pump method (P:0.279). Mean Cleveland Clinic Florida Fecal Incontinence score (CCF_FIS) for the pump was 5.84 compare 6.24 for traditional method (P:0.000). Our study provides evidence for the first time that our novel method can facilitate and speed-up colon irrigation without any adverse effect on the outcome. © 2018 Tehran University of Medical Sciences. All rights reserved. Acta Med Iran 2018;57(4):216-223.

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Standardization of early drain removal following pancreatic resection: proposal of the “Ottawa pancreatic drain algorithm”

Patient Safety in Surgery ◽

10.1186/s13037-019-0219-z ◽

2019 ◽

Vol 13 (1) ◽

Cited By ~ 1

Author(s):

Heather Smith ◽

Fady K. Balaa ◽

Guillaume Martel ◽

Jad Abou Khalil ◽

Kimberly A. Bertens

Keyword(s):

Length Of Stay ◽

Pancreatic Resection ◽

Statistical Significance ◽

Cohort Analysis ◽

Standardized Protocol ◽

Drain Removal ◽

Retrospective Cohort Analysis ◽

Before And After ◽

Drain Amylase ◽

Drain Management

Abstract Background Early drain removal after pancreatic resection is encouraged for individuals with low postoperative day 1 drain amylase levels (POD1 DA) to mitigate associated morbidity. Although various protocols for drain management have been published, there is a need to assess the implementation of a standardized protocol. Methods The Ottawa pancreatic drain algorithm (OPDA), based on POD1 DA and effluent volume, was developed and implemented at our institution. A retrospective cohort analysis was conducted of all patients undergoing pancreatic resection January 1, 2016-October 30, 2017, excluding November and December 2016 (one month before and after OPDA implementation). Results 42 patients pre-implementation and 53 patients post-implementation were included in the analysis. The median day of drain removal was significantly reduced after implementation of the OPDA (8 vs. 5 days; p = 0.01). Early drain removal appeared safe with no difference in reoperation or readmission rate after protocol implementation (p = 0.39; p = 0.76). On subgroup analysis, median length of stay was significantly shorter following OPDA implementation for patients who underwent DP and did not develop a postoperative pancreatic fistula (POPF) (6 vs 10 days, p = 0.03). Although the incidence of both surgical site infection and POPF were reduced following the intervention, neither reached statistical significance (38.1 to 28.3%, p = 0.31; and 38.1 to 28.3%, p = 0.31 respectively). Conclusions Implementing the OPDA was associated with earlier drain removal and decreased length of stay in patients undergoing distal pancreatectomy who did not develop POPF, without increased morbidity. Standardizing drain removal may help facilitate early drain removal after pancreatic resection at other institutions.

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To Bind or to Let Loose: Effectiveness of Sodium Polystyrene Sulfonate in Decreasing Serum Potassium

International Journal of Nephrology ◽

10.1155/2012/940320 ◽

2012 ◽

Vol 2012 ◽

pp. 1-5 ◽

Cited By ~ 8

Author(s):

Shaifali Sandal ◽

Hatim Karachiwala ◽

John Noviasky ◽

Dongliang Wang ◽

William C. Elliott ◽

...

Keyword(s):

Serum Potassium ◽

Retrospective Cohort ◽

Potassium Concentration ◽

Statistical Significance ◽

Cohort Analysis ◽

Sodium Polystyrene Sulfonate ◽

Polystyrene Sulfonate ◽

Baseline Serum ◽

Retrospective Cohort Analysis ◽

Significant Difference

Background. The use of sodium polystyrene sulfonate in decreasing serum potassium has recently been questioned due to the lack of documented effectiveness.Methods. A retrospective cohort analysis of all hospitalized patients who received sodium polystyrene sulfonate over four months was performed. The change in serum potassium was noted over a period of 24 hours. Patients who received any other form of potassium-altering drug or treatment were excluded.Results. The administration of sodium polystyrene sulfonate reduced serum potassium by 16.7% (P<0.001) as compared to the baseline serum potassium over a period of 24 hours. During this same time, no change in serum creatinine was identified (P=0.73). In addition, there was no correlation between potassium and creatinine change (r2= 0.0004 andP=0.99). Patients with higher initial serum potassium (≥5.6 mEq/L) reduced their potassium concentration 4% more than those with initial serum potassium of <5.6 mEq/L; however, this reduction did not reach statistical significance (P=0.32). There was no significant difference in the effectiveness of 15 gm and 30 gm resin preparation (P=0.54). Thirteen deaths were noted in our cohort, of which one death was due to ischemic colitis.Conclusion. We conclude that sodium polystyrene sulfonate is effective in lowering serum potassium.

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Psychiatric Adverse Effects of Levetiracetam in Malignant Glioma Populations; a Retrospective Cohort Study

Journal of Health Science and Medical Research ◽

10.31584/jhsmr.2021814 ◽

2021 ◽

Author(s):

Paul Thisayakorn ◽

Isabel Schuermeyer

Keyword(s):

Adverse Effects ◽

Malignant Glioma ◽

Retrospective Cohort ◽

Cohort Analysis ◽

Cleveland Clinic ◽

Exposed Group ◽

Cancer Center ◽

P Value ◽

Retrospective Cohort Analysis ◽

Increased Risk

Objective: Levetiracetam is commonly used in malignant glioma populations because of its efficacy, limited drug-drug interactions and adverse effects. Although, there has been growing evidence of adverse neuropsychiatric side effects from levetiracetam; however, such evidence in malignant brain tumor settings is limited. Hence, we hypothesized that malignant glioma patients exposed to levetiracetam would also experience more adverse neuropsychiatric effects compared to patients not receiving this medication.Material and Methods: A retrospective cohort analysis was conducted in 150 high grade malignant glioma patients at our Cleveland Clinic Cancer Center; from 2013-2014, comparing the accumulative adverse neuropsychiatric outcomes between patients who received levetiracetam and patients who did not (n=108 and 42, respectively). A sub-analysis of each specific neuropsychiatric side effect between these two groups was performed.Results: Patients with malignant glioma receiving levetiracetam had increased risk of developing neuropsychiatric adverse effects compared to the non-levetiracetam group (odds ratio=2.08, p-value=0.040, 95% confidence interval=1.00-4.36). After adjusting for confounding factors, past psychiatric history and the interaction between seizure and levetiracetam use was significantly associated with neuropsychiatric problems. Delirium, psychosis, and irritability were more common in the levetiracetam group, and likely led to more psychiatric referrals, starting of psychotropic medications, and vitamin B6 use.Conclusion: Incidence of neuropsychiatric presentations in malignant glioma patients was higher in the levetiracetam exposed group than the non-exposed group. The changes, or emergence of new neuropsychiatric behaviors should prompt clinicians to search for possible causes; including levetiracetam adverse effects, so they can be managed accordingly.

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PREDICTORS OF UNSUCCESSFUL OF TREATMENT FOR FECAL INCONTINENCE BIOFEEDBACK FOR FECAL INCONTINENCE IN FEMALE

Arquivos de Gastroenterologia ◽

10.1590/s0004-2803.201900000-17 ◽

2019 ◽

Vol 56 (1) ◽

pp. 61-65 ◽

Cited By ~ 4

Author(s):

Sthela M MURAD-REGADAS ◽

Francisco Sergio P REGADAS ◽

Francisco Sergio P REGADAS FILHO ◽

José Jader de MENDONÇA FILHO ◽

Roberto S ANDRADE FILHO ◽

...

Keyword(s):

Fecal Incontinence ◽

Vaginal Delivery ◽

Cleveland Clinic ◽

Squeeze Pressure ◽

Unsuccessful Treatment ◽

Vaginal Deliveries ◽

Before And After ◽

History Of ◽

The Mean ◽

Satisfactory Clinical Response

ABSTRACT BACKGROUND: Biofeedback is an effective method of treatment for fecal incontinence but there is controversy regarding factors that may be correlated with its effectiveness. OBJECTIVE: To evaluate the efficacy of biofeedback in the treatment of fecal incontinence, identifying the predictive factors for unsuccessful treatment. METHODS: Consecutive female patients who had fecal incontinence and were treated with a full course of biofeedback were screened. The symptoms were evaluated using Cleveland Clinic incontinence (CCF) score before and six months after the completion of therapy. Patients had a satisfactory clinical response to biofeedback if the CCF score had decreased by more than 50% at six months (GI) and an unsatisfactory response if the CCF score did not decrease or if the score decreased by <50% (GII). The groups were compared with regard to age, score, anal resting and squeeze pressures and sustained squeeze pressure by manometry, history of vaginal delivery, number of vaginal deliveries, menopause, hysterectomy, and previous anorectal surgery. RESULTS: Of 124 women were included, 70 (56%) in GI and 54 (44%) in GII. The median CCF score decreased significantly from 10 to 5 (P=0.00). FI scores were higher in GII. Patients from GII had more previous vaginal deliveries and previous surgeries. The mean sustained squeeze pressure was higher in GI. Patients from GI and GII had similar ages, number of vaginal deliveries, menopause, hysterectomy, anal pressures, and sphincter defects. The median sustained squeeze pressure increased significantly before and after biofeedback in GI. CONCLUSION: Biofeedback therapy shows effective treatment with 50% reductions in FI score in half of patients. Factors associated with unsuccessful outcome include FI score ≥10, previous vaginal delivery, previous anorectal and/or colorectal surgery, and reduced mean sustained squeeze pressure.

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Comparison of Pericranial Autograft and AlloDerm for Duraplasty in Patients With Type I Chiari Malformation: Retrospective Cohort Analysis

Operative Neurosurgery ◽

10.1093/ons/opab343 ◽

2021 ◽

Author(s):

Haydn Hoffman ◽

Katherine M Bunch ◽

Tyler Paul ◽

Satish Krishnamurthy

Keyword(s):

Chiari Malformation ◽

Cohort Analysis ◽

Wound Complication ◽

Symptomatic Improvement ◽

Csf Leak ◽

Symptom Improvement ◽

Type I ◽

Exclusion Criteria ◽

Retrospective Cohort Analysis ◽

Csf Leakage

Abstract BACKGROUND Pericranial autograft is a popular option for duraplasty during Chiari decompression with several theoretical advantages, but comparisons to other materials have yielded mixed results. OBJECTIVE To compare outcomes between pericranial autograft and AlloDerm (BioHorizons). METHODS Consecutive suboccipital craniectomies for patients with type I Chiari malformation (CM-I) over an 8-yr period at a single institution were identified. Exclusion criteria included revision surgeries and suboccipital decompressions without duraplasty. Outcomes included incisional cerebrospinal fluid (CSF) leakage, length of stay (LOS), wound complication, aseptic meningitis, syrinx improvement, and symptomatic improvement. RESULTS A total of 101 patients (70 females and 31 males) with a median (interquartile range) age of 17 yr (11-32) met the inclusion criteria. There were 51 (50%) patients who underwent duraplasty with pericranial autograft, and the remainder underwent duraplasty with AlloDerm. There were 9 (9%) patients who experienced a postoperative CSF leak. After adjusting for confounding factors, obesity (odds ratio [OR]: 4.69, 95% CI: 1.03-25.6) and use of AlloDerm (OR: 10.54, 95% CI: 1.7-206.12) were associated with CSF leak. Wound complication occurred in 8 (8%) patients but was not associated with graft type (P = .8). Graft type was not associated with LOS, syrinx improvement, or symptom improvement. Reoperations occurred in 10 patients with 4 in the autograft group and 6 in the AlloDerm group (P = .71). CONCLUSION In patients with CM-I, expansile duraplasty with AlloDerm was associated with greater odds of CSF leakage than pericranial autograft. Obesity was also associated with increased odds of CSF leakage.

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Effects of extracorporeal magnetic stimulation in fecal incontinence

Open Medicine ◽

10.1515/med-2020-0009 ◽

2020 ◽

Vol 15 (1) ◽

pp. 57-64 ◽

Cited By ~ 2

Author(s):

Luigi Brusciano ◽

Claudio Gambardella ◽

Giorgia Gualtieri ◽

Gianmattia Terracciano ◽

Salvatore Tolone ◽

...

Keyword(s):

Electrical Stimulation ◽

Fecal Incontinence ◽

Pelvic Floor ◽

Anorectal Manometry ◽

Magnetic Stimulation ◽

Cleveland Clinic ◽

Common Condition ◽

Endoanal Ultrasonography ◽

Incontinence Score ◽

Non Invasive

AbstractBackgroundFecal incontinence (FI) is a common condition that has devastating consequences for patients’ QOL. In some patients, the conventional functional pelvic floor electrical stimulation has been effective but is an invasive and embarrassing treatment. The object of the study was to evaluate the feasibility of functional extracorporeal magnetic stimulation (FMS) in strengthening the pelvic floor muscles without an anal plug and the embarrassment of undressing.Materials and MethodsThirty patients (26 female and 4 males) with FI were enrolled. All patients were assessed during a specialized coloproctology evaluation followed by endoanal ultrasonography and anorectal manometry. All patients underwent an FMS treatment once weekly for 8 weeks. Patients’ outcome was assessed by the Cleveland Clinic Fecal Incontinence Score (CCFIS) and by the fecal incontinence QOL questionnaire (FIQL).ResultsAfter 8 weeks, the number of solid and liquid stool leakage per week was significantly reduced (p<0.05) with a significant improvement of the CCFIS and of the FIQL (p<0.05). Moreover, the authors recorded a missed recruitment of the agonist and antagonists’ defecation muscles.ConclusionFMS is a safe, non-invasive and painless treatment for FI. It could be recommended for selected patients with non-surgical FI to ensure a rapid clinical improvement.

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