Effect of laser acupuncture on adhesive small bowel obstruction: A prospective double-blind randomized controlled trial.
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ABSTRACT: Background
Adhesive small bowel obstruction (ASBO) is one of the most common complications and is a major cause of re-admission after intra-abdominal surgery. The initial management of patients with ASBO is nonoperative treatment such as nil per os and decompression using a nasogastric tube. However, the ideal management of ASBO remains controversial.Methods
This study will be a prospective, single-center, double-blind randomized controlled trial. Ninety two participants diagnosed with ASBO will be randomly assigned to either the verum or the sham laser acupuncture (SLA) group in a 1:1 ratio. All participants will undergo laser acupuncture (LA) or SLA once a day on 6 acupoints (LI4, PC6, ST25, ST36, CV4 and CV12) for 6 consecutive days after enrollment. The primary outcome measure will be the success rate of conservative treatment for ASBO. Secondary outcomes will be time to oral intake and length of hospital stay. The serum levels of lipase, amylase, cortisol, motilin, ghrelin, and intestinal fatty acid binding protein (I-FABP) will also be measured before intervention, on day 4, and on the day of discharge, respectively. Data will be analyzed by Chi-Squared test or t test between 2 groups.Objectives
The aim of this protocol is to investigate the clinical efficacy of LA on ASBO.Trial registration
ClinicalTrials.gov Identifier: NCT04318821. Registered on 24 March 2020.
SUBMITTER: Shih CH
PROVIDER: S-EPMC7939224 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:INTRODUCTION:Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy that causes hand discomfort and work disability. Since no satisfactory conventional treatments for mild to moderate CTS exist, we apply complementary alternative medicine (CAM) to this problem. Laser acupuncture (LA), a new, non-invasive therapy which uses low-level-laser therapy (LLLT) in acupuncture could help to manage CTS. However, only one small randomized, double-blind and crossover trial had been conducted, which is not enough to provide an evidence-based assessment of the effects of LA on CTS. OBJECTIVES:The aim of this study protocol is to investigate the efficacy of LA therapy on patients with mild to moderate CTS through sonography of the median nerve and offer clear parameters of LLLT. METHODS:This study protocol is a prospective double-blind randomized controlled trial. Forty subjects aged 20 to 80 years old and diagnosed as having mild to moderate CTS will be randomly assigned to the intervention group (real LA, 3-sessions a week for 2 weeks) and control group (sham LA, 3-sessions a week for 2 weeks). All subjects will be asked to wear night splints as the fundamental management approach. The laser parameters will include a wavelength of 808?nm, power output of 300 mW and power density of 300 mW/mm, with ten seconds of treatment for each acupuncture point (PC4, PC6, PC7, PC8, LI4, LI10, LI11, HT3, HT7, and LU10). Sham LA treatment will be applied without any laser power output. The primary outcome will be based the Boston Carpal Tunnel Syndrome Questionnaire and secondary outcomes included a visual analog scale, cross sectional area of median nerve by sonography and electrophysiological test before interventions and after 2, 4, 8, 12 weeks postintervention. TRIAL REGISTRATION:ClinicalTrials.gov (Identifier: NCT03580265).
| S-EPMC6709042 | biostudies-literature
Project description:BackgroundNonoperative management of adhesive small bowel obstruction (SBO) is successful in up to 80% of patients. Current recommendations advocate for computed tomography (CT) scan in all patients with SBO to supplement surgical decision-making. The hypothesis of this study was that cumulative findings on CT would predict the need for operative intervention in the setting of SBO.MethodsThis is an analysis of a retrospectively and prospectively collected adhesive SBO database over a 6-year period. A Bowel Ischemia Score (BIS) was developed based on the Eastern Association for the Surgery of Trauma guidelines of CT findings suggestive of bowel ischemia. One point was assigned for each of the six variables. Early operation was defined as surgery within 6 hours of CT scan.ResultsOf the 275 patients in the database, 249 (90.5%) underwent CT scan. The operative rate was 28.3% with a median time from CT to operation of 21 hours (Interquartile range 5.2-59.2 hours). Most patients (166/217, 76.4%) with a BIS of 0 or 1 were successfully managed nonoperatively, whereas the majority of those with a BIS of 3 required operative intervention (5/6, 83.3%). The discrimination (area under the receiver operating characteristic curve) of BIS for early surgery, any operative intervention, and small bowel resection were 0.83, 0.72, and 0.61, respectively.ConclusionThe cumulative signs of bowel ischemia on CT scan represented by BIS, rather than the presence or absence of any one finding, correlate with the need for early operative intervention.
| S-EPMC9057653 | biostudies-literature
Project description:ObjectiveTo assess the effectiveness of conservative treatment for adhesive small bowel obstruction (ASBO) in children.DesignSystematic review of studies involved children with ASBO who received initial conservative/non-operative treatment.SettingThe search was performed in April 2013 using PubMed (see online supplementary file 1), current contents, and the Cochrane database.ParticipantsChildren with ASBO.InterventionsConservative treatment included nasogastric decompression, parenteral fluids and correction of electrolyte and fluid imbalance.Primary outcomeTreatment success.Secondary outcomesLength of hospital stay and the time to first feeding after hospital admission.Results7 studies (six retrospective, one prospective), involving 8-109 patients (age: 1 month to 16 years) treated conservatively, were included in the review. The nature of conservative treatment was generally consistent between studies (nasogastric decompression, parenteral fluids and correction of electrolyte and fluid imbalance), although patients in one study also received Gastrografin. The rate of conservative treatment success ranged from 16% to 75% among the five studies, but one trial showed 0% successful rate. The hospital length of stay ranged from 3 to 6.5 days for conservative treatment (vs 10.2-13 days for operative treatment). The time to first feeding ranged from 31 to 84 h for conservative treatment.ConclusionsIn conclusion, in the majority of cases, conservative treatment is an effective means of managing ASBO in children.
| S-EPMC4166136 | biostudies-literature
Project description:BackgroundAdhesive small bowel obstruction (ASBO) is one of the most common causes of postoperative morbidity. According to Boyle's law, decreased barometric pressure expands the volume of intestinal gas. We aimed to elucidate the relationship between barometric pressure and ASBO.MethodsWe divided 215 admissions of 120 patients with ASBO into three groups: the fasting group, which responded to fasting (n = 51); the decompression group, which was successfully treated with gastrointestinal decompression (n = 104); and the surgery group which required emergency or elective surgery to treat ASBO (n = 60). We compared and examined clinical backgrounds, findings on admission, and barometric pressure during the peri-onset period (29 days: from 14 days before to 14 days after the onset of ASBO).ResultsThere were significant differences among the three groups regarding gender, history of ASBO, hospital length of stay, and barometric pressure on the onset day of ASBO. Barometric pressure on the onset day was significantly higher in the fasting group than in the decompression group (p = 0.005). During pre-onset day 5 to post-onset day 2, fluctuations in the barometric pressure in the fasting and decompression groups showed reciprocal changes with a symmetrical axis overlapping the median barometric pressure in Matsumoto City; the fluctuations tapered over time after onset. In the fasting group, the barometric pressure on the onset day was significantly higher than that on pre-onset days 14, 11, 7, 4, 3, and 2; post-onset days 3 and 10; and the median pressure in Matsumoto City. Conversely, in the decompression group, the barometric pressure on the onset day was lower than that on pre-onset days 14, 5-2; post-onset days 1, 2, 7, 8, 11, 13, and 14; and the median pressure in Matsumoto City. In the surgery group, the barometric pressure on the onset day was equivalent to those on the other days.ConclusionsASBO with response to conservative treatment is vulnerable to barometric pressure. Additionally, ASBO that is successfully treated with fasting and decompression is associated with a different barometric pressure on the onset day and reciprocal fluctuations in the barometric pressure during the peri-onset period.
| S-EPMC7382815 | biostudies-literature
Project description:BackgroundLaparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction. Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients. However, no prospective, randomized, controlled trials comparing laparoscopy to open surgery have been published.Methods/designThis is a multicenter, prospective, open label, randomized, controlled trial comparing laparoscopic adhesiolysis to open surgery in patients with computed-tomography diagnosed adhesive small bowel obstruction that is not resolving with conservative management. The primary study endpoint is the length of postoperative hospital stay in days.Sample size was estimated based on preliminary retrospective cohort, which suggested that 102 patients would provide 80% power to detect a difference of 2.5 days in the length of postoperative hospital stay with significance level of 0.05. Secondary endpoints include passage of stool, commencement of enteral nutrition, 30-day mortality, complications, postoperative pain, and the length of sick leave. Tertiary endpoints consist of the rate of ventral hernia and the recurrence of small bowel obstruction during long-term follow-up. Long-term follow-up by letter or telephone interview will take place at 1, 5, and 10 years.DiscussionTo the best of our knowledge, this trial is the first one aiming to provide level Ib evidence to assess the use of laparoscopy in the treatment of adhesive small bowel obstruction.Trial registrationClinicalTrials.gov identifier: NCT01867528. Date of registration May 26th 2013.
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Project description:BACKGROUND:Surgical training has long been to "never let the sun set on a bowel obstruction" without an operation to rule out and/or treat compromised bowel. However, advances in diagnostics have called into question the appropriate timing of non-emergent operations and expectant management is increasingly used. We performed a systematic review to evaluate the safety and effectiveness of expectant management for adhesive small bowel obstruction (aSBO) compared to early, non-emergent operation. MATERIALS & METHODS:We queried PubMed, EMBASE, and Cochrane databases for studies (1990-present) comparing early, non-emergent operations and expectant management for aSBO (PROSPERO #CRD42017057676). RESULTS:Of 4873 studies, 29 cohort studies were included for full-text review. Four studies directly compared early surgery with expectant management, but none excluded patients who underwent emergent operations from those having early non-emergent surgery, precluding a direct comparison of the two treatment types of interest. When aggregated, the rate of bowel resection was 29% in patients undergoing early operation vs. 10% in those undergoing expectant management. The rate of successful, non-operative management in the expectant group was 58%. There was a 1.3-day difference in LOS favoring expectant management (LOS 9.7 vs. 8.4 days), and the rate of death was 2% in both groups. CONCLUSION:Despite the shift towards expectant management of aSBO, no published studies have yet compared early, non-emergent operation and expectant management. A major limitation in evaluating the outcomes of these approaches using existing studies is confounding by indication related to including patients with emergent indications for surgery on admission in the early operative group. A future study, randomizing patients to early non-emergent surgery or expectant management, should inform the comparative safety and value of these approaches.
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Project description:ObjectiveTo determine if infrared laser acupuncture (LA) may have a specific effect in reducing pain and disability in treatment of chronic low back pain (LBP).MethodsThis was a double-blind sham laser controlled trial performed in general practices in Perth, Western Australia. The participants were 144 adults with chronic non-specific LBP. They were randomised to receive eight once-weekly treatments. Laser machines (20 mW, 840 nm diode, power density 0.1 W/cm(2)) stimulated points in three treatment groups: sham (0 joules/point), low dose (0.2 J/point) and high dose (0.8 joules/point). Participants were followed-up at 1 and 6 weeks, and 6 and 12 months post treatment. Primary outcomes were pain (Numerical Pain Rating Scale (NPRS)) and disability (Oswestry Disability Inventory (ODI)) at 6 weeks post treatment. Secondary outcomes included numerical rating scale for limitation of activity, global assessment of improvement, analgesic usage and adverse effects after treatment.ResultsThe analysis showed no difference between sham and the laser groups at 6 weeks for pain or disability. There was a significant reduction in mean pain and disability in all groups at 6 weeks (p<0.005); NPRS: sham (-1.5 (95% CI -2.1 to -0.8)), low dose (-1.3 (-2.0 to -0.8)), high dose (-1.1 (-1.7 to -0.5)). ODI: sham (-4.0 (-7.1 to -1.0)), low dose (-4.1, (-6.7 to -1.5)), high dose (-2.6 (-5.7 to 0.5)). All secondary outcomes also showed clinical improvement over time but with no differences between groups.ConclusionsLA using energy density range (0-4 J/cm(2)) for the treatment of chronic non-specific LBP resulted in clinical improvement unrelated to laser stimulation.Trial registrationhttp://www.anzctr.org.au ACTRN12610000043033.
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Project description:BACKGROUND:This study aims to describe the mechanisms of adhesive small bowel obstruction (SBO) and its morbidity, mortality and recurrence after surgery for SBO in a defined population. METHOD:Retrospective study of 402 patients (240 women, median age 70 years, range 18-97) who underwent surgery for SBO in the Uppsala and Gävleborg regions in 2007-2012. Patients were followed to last note in medical records or death. RESULT:The cause of obstruction was a fibrous band in 56% and diffuse adhesions in 44%. Early overall postoperative morbidity was 48 and 10% required a re-operation. Complications, intensive care and early mortality (n = 21, 5.2%) were related to age (p < 0.05) and American Society of Anesthesiologist's class (p < 0.01). At a median follow-up of 66 months (0-122), 72 patients (18%) had been re-admitted because of SBO; 26 of them underwent a re-operation. Previous laparotomies (p = 0.013), diffuse adhesions (p = 0.050), and difficult surgery (bowel injury, operation time and bleeding, p = 0.034-0.003) related to recurrent SBO. The cohort spent 6735 days in hospital due to SBO; 772 of these days were due to recurrent SBO. In all, 61% of the cohort was alive at last follow-up. Late mortality was related to malignancies, cardiovascular disease, and other chronic diseases. CONCLUSIONS:About half of patients with SBO are elderly with co-morbidities which predispose to postoperative complications and mortality. Diffuse adhesions, which make surgery difficult, were common and related to future SBO. Overall, nearly one-fifth of patients needed re-admission for recurrent SBO. Continued research for preventing SBO is desirable. TRIAL REGISTRATION:The study was registered at ClinicalTrials.gov (NCT03534596, retrospectively registered, 2018-05-24).
| S-EPMC7137409 | biostudies-literature
Project description:BackgroundAdhesive small bowel obstruction (aSBO) is a potentially recurrent disease. Although non-operative management is often successful, it is associated with greater risk of recurrence than operative intervention, and may have greater downstream morbidity and costs. This study aimed to compare the current standard of care, trial of non-operative management (TNOM), and early operative management (EOM) for aSBO.MethodsPatients admitted to hospital between 2005 and 2014 in Ontario, Canada, with their first episode of aSBO were identified and propensity-matched on their likelihood to receive EOM for a cost-utility analysis using population-based administrative data. Patients were followed for 5 years to determine survival, recurrences, adverse events and inpatient costs to the healthcare system. Utility scores were attributed to aSBO-related events. Cost-utility was presented as the incremental cost-effectiveness ratio (ICER), expressed as Canadian dollars per quality-adjusted life-year (QALY).ResultsSome 25 150 patients were admitted for aSBO and 3174 (12·6 per cent) were managed by EOM. Patients managed by TNOM were more likely to experience recurrence of aSBO (20·9 per cent versus 13·2 per cent for EOM; P < 0·001). The lower recurrence rate associated with EOM contributed to an overall net effectiveness in terms of QALYs. The mean accumulated costs for patients managed with EOM exceeded those of TNOM ($17 951 versus $11 594 (€12 288 versus €7936) respectively; P < 0·001), but the ICER for EOM versus TNOM was $29 881 (€20 454) per QALY, suggesting cost-effectiveness.ConclusionThis retrospective study, based on administrative data, documented that EOM may be a cost-effective approach for patients with aSBO in terms of QALYs. Future guidelines on the management of aSBO may also consider the long-term outcomes and costs.
| S-EPMC7528511 | biostudies-literature
Project description:Importance:Adhesive small-bowel obstruction (aSBO) is a potentially chronic, recurring surgical illness. Although guidelines suggest trials of nonoperative management, the long-term association of this approach with recurrence is poorly understood. Objective:To compare the incidence of recurrence of aSBO in patients undergoing operative management at their first admission compared with nonoperative management. Design, Setting, and Participants:This longitudinal, propensity-matched, retrospective cohort study used health administrative data for the province of Ontario, Canada, for patients treated from April 1, 2005, through March 31, 2014. The study population included adults aged 18 to 80 years who were admitted for their first episode of aSBO. Patients with nonadhesive causes of SBO were excluded. A total of 27 904 patients were included and matched 1:1 by their propensity to undergo surgery. Factors used to calculate propensity included patient age, sex, comorbidity burden, socioeconomic status, and rurality of home residence. Data were analyzed from September 10, 2017, through October 4, 2018. Exposures:Operative vs nonoperative management for aSBO. Main Outcomes and Measures:The primary outcome was the rate of recurrence of aSBO among those with operative vs nonoperative management. Time-to-event analyses were used to estimate hazard ratios of recurrence while accounting for the competing risk of death. Results:Of 27 904 patients admitted with their first episode of aSBO, 6186 (22.2%) underwent operative management. Mean (SD) patient age was 61.2 (13.6) years, and 51.1% (14 228 of 27 904) were female. Patients undergoing operative management were younger (mean [SD] age, 60.2 [14.3] vs 61.5 [13.4] years) with fewer comorbidities (low burden, 382 [6.2%] vs 912 [4.2%]). After matching, those with operative management had a lower risk of recurrence (13.0% vs 21.3%; hazard ratio, 0.62; 95% CI, 0.56-0.68; P < .001). The 5-year probability of experiencing another recurrence increased with each episode until surgical intervention, at which point the risk of subsequent recurrence decreased by approximately 50%. Conclusions and Relevance:According to this study, operative management of the first episode of aSBO is associated with significantly reduced risk of recurrence. Guidelines advocating trials of nonoperative management for aSBO may assume that surgery increases the risk of recurrence putatively through the formation of additional adhesions. The long-term risk of recurrence of aSBO should be considered in the management of this patient population.
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