Prospective Randomized Pilot Study Research Articles

Effects of Mokuboito, a Japanese Kampo medicine, on symptoms in patients hospitalized for acute decompensated heart failure – A prospective randomized pilot study

BackgroundAlthough standard treatment for heart failure (HF) has been established, it remains difficult to relieve HF-associated symptoms in some patients. Kampo medicines have been used to treat various diseases; however, it remains unclear whether they are effective in HF patients. We therefore performed a prospective, randomized, controlled trial to investigate whether Mokuboito, a Kampo medicine, affected symptoms and other parameters in hospitalized patients with acute decompensated HF (ADHF), as compared to standard therapy alone. MethodsForty patients were allocated randomly to Group S (standard therapy alone) or Group M (oral administration of Mokuboito plus standard therapy). The primary outcome was changes in global clinical status based on a visual analog scale (VAS) from baseline at day 10 or discharge if earlier. ResultsThe decrease in VAS score was significantly greater in Group M than Group S (p=0.001). Although there were no differences between the groups in changes in the secondary endpoints of body weight, peripheral edema, biochemical and echocardiographic parameters, left ventricular end-diastolic diameter, and serum total bilirubin levels were significantly reduced in Group M (p=0.038; 0.002, respectively) but not in Group S, implying that Mokuboito might attenuate organ congestion and cardiac preload. ConclusionsOral administration of Mokuboito significantly improved ADHF-related symptoms. Our observations might provide the basis for a novel therapeutic strategy in hospitalized patients with ADHF.

Re: A Prospective Randomized Pilot Study Evaluating an ERAS Protocol versus a Standard Protocol for Patients Treated with Radical Cystectomy and Urinary Diversion for Bladder Cancer.

Re: A Prospective Randomized Pilot Study Evaluating an ERAS Protocol versus a Standard Protocol for Patients Treated with Radical Cystectomy and Urinary Diversion for Bladder Cancer.

Impact of compression stockings on leg swelling after arthroscopy \u2013 a prospective randomised pilot study

BackgroundPost-operative limb swelling may negatively affect the outcome of arthroscopic surgery and prolong rehabilitation. The aim of this pilot study was to evaluate the effect of compression stockings versus no compression on post-operative swelling and pain in the early post-operative phase.MethodsA single-centre, randomised controlled trial was performed. Patients who underwent minor knee arthroscopy were randomised to wear class II compression stockings (23-32 mmHg) (CS) or no compression stockings (NCS) immediately post-operatively for ten days. All patients received low molecular weight heparin (LMWH) at prophylactic dosage. The primary outcome variable was post-operative swelling of the limb, quantified by using an optical 3D measurement system (Bodytronic© 600). Pain was rated on a visual analogue scale (VAS). From a total of 76 patients assessed, 19 patients were eligible for final analysis. The trial followed the CONSORT criteria, was registered at clinicaltrial.gov and approved by the local ethics committee.ResultsThe circumference at the middle thigh (cF) was significantly different between groups at day 10 (p = 0.032; circumference − 1.35 ± 2.15% (CS) and + 0.79 ± 3.71% (NCS)). Significant differences were also noted around the knee (cD) at day 10 (p = 0.026) and a significant trend at cD and at the mid lower leg (cB1) at day 4. The volume of the thigh was also different with marked difference between days 1 and 4 between the two groups (p = 0.021; volume + 0.54 ± 2.03% (CS) and + 4.17 ± 4.67 (NCS)). Pain was lower in compression group (not statistically significant).ConclusionsPost-operative limb swelling can be reduced significantly by wearing compression stockings in the early post-operative phase when compared to not wearing stockings. This may improve the rehabilitation process after arthroscopic surgery. The optimal duration of compression therapy seems to be between three and ten days.Trial registrationclinicaltrials.gov (NCT02096562, date of registration 11.11.2013).

Protocol for prospective randomised assessor-blinded pilot study comparing hyperbaric oxygen therapy with PENtoxifylline+TOcopherol± CLOdronate for the management of early osteoradionecrosis of the mandible

IntroductionOsteoradionecrosis (ORN) of the mandible is a painful and debilitating condition occurring after radiotherapy to the head and neck to treat cancer. For decades, hyperbaric oxygen (HBO) has formed the...

Volumetric Analysis of Allogeneic and Xenogeneic Bone Substitutes Used in Maxillary Sinus Augmentations Utilizing Cone Beam Computed Tomography: A Prospective Randomized Pilot Study

The purpose of this prospective randomized clinical pilot study was to compare the three-dimensional changes of grafted maxillary sinuses when deproteinized bovine bone (DBB) or cortical mineralized allogeneic bone (MAB) was used. Seventeen patients were randomly assigned to receive either DBB or MAB for lateral-approach maxillary sinus augmentation. Cone beam computed tomography (CBCT) scans were performed preoperatively (T0), immediately after (T1), and at approximately 6 months posthoperatively (T2). Three-dimensional analysis of the radiographic volumetric changes was performed for DBB and MAB by measuring the difference in unoccupied sinus volumes at T1 and T2. In the DBB group, a statistically significant increase in unoccupied sinus volume was found at T2 when compared to T1 (P = .001). It represents a mean resorption rate of 23.8% ± 15.9%. Similarly in the MAB group, a statistically significant increase in unoccupied sinus volume was found at T2 when compared to T1 (P = .007). The mean resorption rate in the MAB group was 19.5% ± 10.1%. There was no statistically significant difference between the contraction of DBB (23.8%) and MAB (19.5%) (P = .52). Both DBB and MAB showed sufficient volume stability at T2 (mean 6.3 ± 1.6 months) postoperatively for 10- to 13-mm-implant placement without the need for additional grafting.

A comparison of infection rates during skin cancer excisions using nonsterile vs sterile gloves: A prospective randomized pilot study.

Standard surgical skin excision is a routine outpatient procedure commonly performed in Dermatology practice to treat nonmelanoma and melanoma skin cancer. Use of sterile gloves during this procedure has been the standard of care in most Dermatology offices. To determine whether the incidence of infection rates was affected when using nonsterile gloves (NSG) instead of sterile gloves (SG) during standard skin excisions in an outpatient Dermatology clinic setting. This prospective, subject-blinded, single-center trial randomized 93 patients presenting for routine skin cancer excisions into two groups. In the first group, 53 excisions were performed with NSG and in the second group 53 excisions were performed with sterile gloves. Degree of wound inflammation and wound infection at 48-72hours postprocedure was measured. One hundred and six total wounds were included. Zero of 53 were infected in the NSG group, and 0/53 were infected in the SG at the initial screening 48-72hours postexcision procedure (P=0.99). The average wound inflammation score was 0.321 for the NSG group and 0.245 for the SG group. Our study suggests that NSG are safe to use for simple excisions of cutaneous skin cancers in an outpatient dermatology clinic setting.

Effect of Perioperative Pregabalin on Incidence of Chronic Postmastectomy Pain Syndrome: A Prospective Randomized Placebo-Controlled Pilot Study.

Background:Breast cancer is the most common malignancy among women. Chronic pain after breast surgeries is a well-known entity and is mainly neuropathic in nature. The primary aim of this study was to assess the effect of pregabalin given as preventive analgesic on the incidence of chronic postmastectomy pain.Methods:A randomized control trial (RCT) was performed on 80 patients. Patients were allocated into two groups. Group 1 received pregabalin (Lyrica, Pfizer) 75 mg. BD starting from the morning of surgery and continued for 1 week. Group 2 received placebo capsules at identical time intervals. Patients were followed up for 3 months postoperatively. Incidence, severity, and location of chronic pain were recorded. The primary objective was to evaluate the effect of perioperative oral pregabalin on the incidence of chronic postmastectomy pain (at 3 months postoperatively).Results:Of the 80 patients enrolled, 71 patients completed the study and were assessed for final outcomes. Incidence of chronic pain was comparable in both groups, with 16 out of 35 patients in Group 1 (44.7%) and 20 out of 36 patients in Group 2 (55.6%) reported chronic pain (P = 0.407). There was no difference between the severity of chronic pain (numeric rating scale ≥ 4) in both groups (P = 0.307). Incidence of adverse effects was comparable in both groups.Conclusion:This RCT shows that perioperative pregabalin may not have a role in the prevention of chronic pain after breast surgeries.

Facial nerve dysfunction after superficial parotidectomy with or without continuous intraoperative electromyographic neuromonitoring: a prospective randomized pilot study.

There are no randomized trials comparing the incidence or severity of facial nerve dysfunction after superficial parotidectomy with or without continuous intraoperative electromyographic neuromonitoring. This pilot study aimed to assess the variability in outcomes to help determine the needs and possible ethical issues in a full-scale study. Prospective randomized pilot study comparing the incidence and grade of facial nerve dysfunction among 106 patients subjected to superficial parotidectomy with or without continuous four channels electromyographic neuromonitoring (52 monitored patients and 54 controls). The incidences of immediate (38.3% vs. 51.8%, p = 0.1) and late facial dysfunction, up to 180days following surgery, (3.8% vs. 5.5%, p = 0.4) were similar between monitored patients and controls. Immediate facial nerve dysfunction with a House-Brackmann ≥ grade III was more frequent among the non-monitored patients (57.8% vs. 30%, p = 0.2), and outcomes were significantly poorer in this group (mean sum score of 68.7 vs. 81.5, p = 0.002), when assessed with the regional Sunnybrook scale. A full-scale prospective randomized study to detect a significant reduction in the incidence of immediate facial nerve dysfunction with the use of continuous intraoperative electromyographic neuromonitoring, with 80% power and a 5% significant level, would require 560 patients allocated to the monitored and control groups. Considering a mean rate of 30 patients/year/center, such a study would require the participation of five centers for 4years. In the present pilot study, the incidences of immediate and late facial nerve dysfunction were similar between patients with benign parotid tumors subjected to superficial parotidectomy with or without continuous intraoperative electromyographic neuromonitoring. However, immediate facial dysfunction was more severe among the non-monitored patients.

Prospective Randomized Controlled Pilot Study on Orbital Blowout Fracture.

To clarify the conflicting recommendations for care of blowout fracture (BOF), a prospective randomized study is required. Here, we present a prospective randomized pilot study on BOF. This article aimed to evaluate which computed tomography (CT) findings predict late functional and/or cosmetic symptoms in BOF patients with ≥ 1.0 mL herniation of orbital content into maxillary and/or ethmoidal sinuses. It also aimed to evaluate which patients with BOF would benefit from surgical treatment or observational follow-up. Twenty-six patients with BOF ≥ 1.0 mL herniation were randomized to observational ( n = 10) or surgical treatments ( n = 16) and were followed up for functional and cosmetic symptoms for at least 1 year. The results from CT scan measurements were correlated to the patients' symptoms and clinical findings which we report in this pilot study. Of the 10 patients randomized to observation, five had an inferomedial BOF with a herniation of ≥ 1.3 mL and all patients developed cosmetic deformities and required surgery. The remaining five patients in the observational group had inferior BOF and one of them had a distance of 3.3 cm from the inferior orbital rim to the posterior edge of the fracture and developed a cosmetic deformity but was unwilling to proceed to surgical treatment, and four patients had a median distance of 2.9 cm from the inferior orbital rim to the posterior edge of the fracture and did not develop cosmetic deformities. The median time from injury to surgery was 13 (3-17) days for the surgical group and 37 (17-170) days for the patients who underwent surgery in the observational group. The surgical results were similar for all the operated patients at the final control. Diplopia decreased and remained partly in one patient in the surgical group and in two patients in the observational group. Hypoesthesia of the infraorbital nerve decreased in nonsurgically treated patients, but surgery seemed to induce hypoesthesia. In this prospective randomized controlled pilot study on BOF, all patients in the observational group with inferomedial fractures developed visible deformity. Diplopia in BOF, without ocular motility limitation, is believed to be due to edema. Diplopia is not an indication for surgery as long as it reduces over time.

1465Hybrid coronary revascularization in selected patients with multivessel disease - 5 year clinical outcomes of the prospective randomized pilot study

1465Hybrid coronary revascularization in selected patients with multivessel disease - 5 year clinical outcomes of the prospective randomized pilot study

Randomized Controlled Pilot Study of Video Self-assessment for Resident Mastoidectomy Training.

A prospective randomized controlled pilot study was performed to determine if video self-assessment improves competency in mastoidectomy and to assess interrater agreement between expert and resident evaluations of recorded mastoidectomy. Sixteen otolaryngology residents were recorded while performing cadaveric mastoidectomy and randomized into video self-assessment and control groups. All residents performed a second recorded mastoidectomy. Performance was evaluated by blinded experts with a validated assessment scale. Video self-assessment did not lead to greater skill improvement between the first and second mastoidectomy. Interrater agreement was fair to substantial between the expert evaluators and between resident self-evaluations by recall and video review. Agreement between experts and residents was only slight to fair; residents consistently rated their performance higher than experts (P < .05). In conclusion, 1 session of video self-review did not lead to improved competence in mastoidectomy over standard practice. While experts agree on assessments, residents may overestimate their competency in performing cadaveric mastoidectomy.

Subcutaneous tranexamic acid in upper eyelid blepharoplasty: a prospective randomized pilot study

ObjectivePostoperative ecchymoses or hematomas can prolong healing from surgery, and a search for locally administered agents that decrease bleeding is warranted. The objective of this study is to evaluate whether preoperative subcutaneous injection of tranexamic acid (TXA) reduces intra- and postoperative bleeding or ecchymoses in skin-only upper eyelid blepharoplasty surgery. DesignThis is a prospective randomized, double-blind, controlled study. ParticipantsWe included 34 consecutive patients who were referred to an upper eyelid blepharoplasty surgery in our institution. MethodsThe patients were equally randomized to a preoperative local injection of lidocaine mixed with either TXA or normal saline. All patients stopped antiaggregates 1 week before surgery. All surgeries were performed by a single surgeon who was unaware of group assignment. Total surgical time, cumulative time of cautery use, blood loss, the surgeon’s assessment of bleeding extent, pain level reported by the patient, periocular ecchymoses during the first postoperative week, and time for patient’s return to normal daily activity were recorded. ResultsThere was a trend toward smaller ecchymoses in the TXA group compared with the placebo group on the seventh day (p = 0.072). There were no group differences in total surgery time, cumulative cautery time, net blood weight in surgical pads, patient-reported pain level, surgeon’s assessment of hemostasis, or periocular ecchymosis size on the first postoperative day. ConclusionsSubcutaneous TXA was associated with similar intra- and postoperative hemorrhage in upper eyelid blepharoplasty compared with placebo. The effect of TXA in patients who did not stop antiaggregate use before surgery warrants further study.

Hybrid myocardial revascularization.

In patients with advanced coronary artery disease (CAD), coronary artery bypass grafting (CABG) is associated with improved long-term outcomes while percutaneous coronary intervention (PCI) is associated with lower periprocedural complications. A new approach has emerged in the last decade that attempts to reap the benefits of bypass surgery and stenting while minimizing the shortcomings of each approach, hybrid myocardial revascularization (HMR).Three strategies for timing of the hybrid revascularization exists, each with their own inherent advantages and shortcomings: (1) CABG followed by PCI, (2) PCI followed by CABG, or (3) simultaneous CABG + PCI in a hybrid suite. The results of the first randomized control trial comparing HMR (CABG first) and standard CABG, POL-MIDES (Prospective Randomized PilOt Study EvaLuating the Safety and Efficacy of Hybrid Revascularization in MultIvessel Coronary Artery DisEaSe), show HMR was feasible for 93.9% of patients whereas conversion to standard CABG was required for 6.1%. At 1year, both groups had similar all-cause mortality (CABG 2.9% vs. HMR 2%) and major adverse clinical event (MACE)-free survival rates (CABG 92.2% vs. HMR 89.8%). Results of observational and comparative studies show that minimally invasive HMR procedures in patients with multivessel CAD carry minimal perioperative mortality risk and low morbidity and do not increase the risk of postoperative bleeding. The advantage they offer in comparison to classical surgical revascularization is indeed faster rehabilitation and patient's return to normal life. Hybrid myocardial revascularization has been developed as a promising technique for the treatment of high-risk patients with CAD. Hybrid revascularization using minimally invasive surgical techniques combined with PCI offers to a part of patients an advantage of optimal revascularization of the most important artery of the heart, together with adequate myocardial revascularization in a relatively delicate way. Indeed, to patients with high operative risk of standard surgery, it offers an alternative which should be considered carefully.

Regenerative efficacy of therapeutic quality platelet-rich plasma injections versus phonophoresis with kinesiotaping for the treatment of chronic plantar fasciitis: A prospective randomized pilot study.

BACKGROUND:Plantar fasciitis (PF) a common chronic musculoskeletal pain routinely diagnosed and treated in rehabilitation practices. When conservative management fails in this degenerative disease, local injections of corticosteroids, platelet rich plasma (PRP), botulinum toxin, extracorporeal shockwave therapy, surgical release are used. In our prospective randomized pilot study we compared the regenerative efficacy of Platelet Rich Plasma vs Kinesiotaping with phonophoresis who were resistant to conservative management of PF.MATERIALS AND METHODS:Sixty-four chronic plantar fasciitis patients nonresponding to conservative management were evaluated for two interventions.36 patients received ultrasound guided 2.5 ml autologous platelet rich plasma (PRP) injection and 28 participant received phonophoresis and total10 Kinesiotaping on alternate days. 54 participants 33 in PRP intervention group and 21 in KT group were analyzed, by Numerical Rating Scale (NRS), plantar fascia thickness (ultrasound guided) and disability and activity limitation measured by foot function index in every two weeks up to 6 months.RESULTS:Post intervention assessment at 2 weeks revealed improvement in pain relief was better in Kinesiotaping group (NRS-4.619) as compared to PRP group (NRS- 6.061). But evaluation at 12 and 24 weeks showed statistically significant improvement in NRS and Foot function index in PRP group than in Kinesiotaping. Similarly, at the end of 24-week improvement in foot function index (FFI) was more in PRP group (P<0.0001). At end of 12 and 24 weeks there was significant reduction in plantar fascia thickness in PRP group (p<0.0001) as compared to KT group (p<0.05).CONCLUSION:Our study concluded that therapeutic quality autologous PRP injection (1x106 platelets/μl) has regenerative effect with long and better efficacy in pain management of chronic recalcitrant plantar fasciitis than Phonophoresis and Kinesiotaping.

Standard vs. Calorie-Dense Immune Nutrition in Haemodynamically Compromised Cardiac Patients: A Prospective Randomized Controlled Pilot Study.

Background. The aim of study was to test the hypothesis that early enteral nutrition (EN) with calorie-dense and protein rich enteral formula improves enteral energy and protein delivery in critically ill cardiac patients. Methods. Prospective randomized pilot study of 40 ventilated adult patients undergoing elective cardiac surgery with use of cardiopulmonary bypass receiving inotropic support postoperatively. Patients were to receive either standard isocaloric (1000 Kcal/L and 38 g/L protein) early EN (n = 20) or calorie-dense and protein-rich (1300 Kcal/L and 66.7 g/L protein) early EN (n = 20). Results. The mean time to EN initiation was 27 ± 11 h. Early EN with the calorie-dense formula provided significantly more energy and protein enteral delivery on the 2nd, (p < 0.0001), 5th (p = 0.036), and 7th days (p = 0.024), and was associated with higher levels of prealbumin concentration on the 14th day (0.13 ± 0.01 g/L and 0.21 ± 0.1 g/L; p = 0.04) and significantly increased levels of transferrin on the 3rd, 5th, and 7th day (p < 0.05) after surgery. Conclusion. Present findings support hypothesis that early EN using a calorie-dense and protein rich formula leads to better enteral energy and protein delivery and higher levels of short-lived serum proteins.

How to Prevent Renal Cachexia? A Clinical Randomized Pilot Study Testing Oral Supplemental Nutrition in Hemodialysis Patients With and Without Human Immunodeficiency Virus Infection

End-stage renal disease associates with catabolism and sarcopenia. Hypothetically, peroral supplemental nutrition over 6months prevents catabolism in hemodialysis patients. Prospective randomized pilot study (ClinicalTrials.gov Identifier: NCT00687050). Twenty-three hemodialysis patients (15 males and 7 females) with or without human immunodeficiency virus (HIV) infection of 2 ambulatory hemodialysis centers. HIV-positive hemodialysis patients (n=7, Group 1) were started on supplemental nutrition drinks (250kcal/day), HIV-negative hemodialysis patients (n=16, Group 2) were randomized to supplemental nutrition drinks (250kcal/day) or received none. Body impedance analysis, anthropometric measures, magnetic resonance imaging results for mid-iliopsoas muscle cross-sectional area and laboratory parameters including albumin, cytokines at baseline, and at 6months follow-up. Seven patients in Group 1 (mean age: 50.6±9.6years) and 16 patients in Group 2 (mean age: 54.0±13.3years) were recruited. Serum creatinine (Group 1: 6.4±3.0mg/dL; Group 2: 10.7±2.5mg/dL; P<.01), Body impedance analysis-derived phase angle alpha (Group 1: 5.1±1.2; Group 2: 6.9±1.6; P<.01), mid-arm circumference (Group 1: 26.1±1.3cm; Group 2: 29.6±2.4cm; P<.01) were less in Group 1 versus Group 2 patients at baseline suggesting that HIV-positive hemodialysis patients had a poorer nutritional status at baseline. At 6-month follow-up, mortality was higher in Group 1 patients (29%) than in Group 2 patients (6%). There was no significant treatment effect on nutritional status in survivors of Group 1 or in the supplemental nutrition arm of Group 2 when compared with baseline or to untreated controls. A new oral supplemental nutrition over 6months had no treatment effect in surviving HIV-positive hemodialysis patients or in maintenance hemodialysis patients without HIV infection. The limitations of this study were small study size and unexpected high mortality among HIV-positive hemodialysis patients.

Respiratory events with sugammadex vs. neostigmine following laparoscopic sleeve gastrectomy: a prospective pilot study assessing neuromuscular reversal strategies.

From September 2012 to February 2013, in a prospective randomized pilot study, two different muscle relaxant reversal agents were administered at the end of surgery in 57 patients undergoing laparoscopic sleeve gastrectomy: sugammadex 2 mg/kg (32 patients) vs. neostigmine 2.5 mg (25 patients). We compared the occurrence of early and late respiratory events/complications by the type of reversal agent. Postoperative respiratory rate, oxyhemoglobin saturation (SpO2), number of patients with SpO2 lower than 95% in PACU, the minimum value of SpO2 in PACU, train-of four counts (TOF) before reversal, unexpected ICU admissions, duration of hospitalization and incidence of reintubation were recorded. SpO2 in the PACU was significantly lower in the neostigmine group - 95.80 (± 0.014)) vs. in sugammadex group - 96.72 (± 0.011) (p < 0.01), despite a lower TOF count measured in the sugammadex group before reversal, meaning a deeper level of residual relaxation in this group before the administration of the reversal agent (2.53 ± 0.98 vs. 3.48 ± 0.58 p < 0.01). Also, the minimal SpO2 was significantly lower in the PACU in the neostigmine group: 93% vs. 94% (p = 0.01). Respiratory rates were not different. After the administration of reversal, both groups had TOF counts of 4 with no fade assessed visually. There were no postoperative respiratory events or complications. The use of sugammadex (as compared to neostigmine) as a reversal agent following laparoscopic sleeve gastrectomy surgery was associated with higher postoperative SpO2 despite the lower TOF count before the administration of reversal agent. Despite the statistical difference in SpO2, its clinical importance seems to be minimal. The lack of difference in the other measured variables may stem from the small number of patients studied (pilot).

Comparison of the Memory Foam Pad Versus the Bean Bag with Shoulder Braces in Preventing Patient Displacement during Gynecologic Laparoscopic Surgery

Study ObjectiveTo compare the amount of patient displacement when a memory foam pad is used versus a bean bag with shoulder braces. The secondary aim was to evaluate for postoperative extremity symptoms including pain, numbness, and weakness. DesignA prospective randomized pilot study (Canadian Task Force classification I). SettingA single academic institution. PatientsWomen ≥18 years of age undergoing laparoscopic or robotic gynecologic surgery. InterventionsPatients were randomized to be positioned on the memory foam pad (group A) or the bean bag with shoulder braces (group B) preoperatively. The patients' positions were measured before and after the procedure, and the displacement was recorded. Patients were followed postoperatively and questioned regarding upper extremity or lower extremity weakness, numbness, and pain. Demographic characteristics were collected using the electronic medical record. Measurements and Main ResultsForty-three patients were included in the study (22 in group A and 21 in group B). The demographic and intraoperative characteristics of the patients were similar in both groups. The patients in group A moved a mean distance of 3.80 ± 3.32 cm, whereas those in group B moved a mean distance of 1.07 ± 1.93 cm (p = .002). A Pearson correlation coefficient did not yield a correlation between patient displacement and age, body mass index, length of surgery, or pathology weight. In group A, 2 patients had lower extremity numbness, and 1 patient had upper extremity numbness. In group B, 1 patient had upper extremity pain, and 1 patient had both upper and lower extremity numbness. These patients had complete resolution of their symptoms within the first 2 weeks postoperatively, with the exception of 1 patient in group A whose lower extremity numbness resolved 3 months postoperatively. ConclusionPositioning patients on the bean bag with shoulder braces resulted in significantly less displacement during gynecologic laparoscopic surgery when compared with the memory foam pad. All postoperative extremity numbness, weakness, and pain were temporary and resolved completely in our cohort. A larger study would be necessary to determine the true incidence of peripheral nerve injuries because these are rare complications of laparoscopic surgeries.

Comparison of Polypropylene Sling with Combined Transconjunctival Retractor Plication and Lateral Tarsal Strip for Correction of Involutional Lower Eye Lid Ectropion

Purpose:The study aims to compare the effectiveness and complications of transconjunctival retractor plication (TRP) with lateral tarsal strip (LTS) and the polypropylene sling (PS) surgery for treatment of involutional lower lid ectropion.Method:A prospective randomised pilot study was conducted on 30 eyes of 30 patients suffering from epiphora having horizontal eyelid laxity >6mm and age >50 years at a tertiary care centre from December 2014 to March 2015. They were randomly divided into two equal groups for TRP with LTS (group A) and PS (group B). Success was defined as relief in epiphora and lid laxity ≤4mm at 12 months post operatively.Result:There were 19 male and 11 female patients with age ranging from 55-80 years. The mean grade of ectropion was 2.80±1.32 in group A and 2.87±1.60 in group B. The preoperative horizontal laxity increased with the grade of ectropion (p <0.001) while medial canthal laxity was variable. The average surgical time per procedure in group A was 66 minutes and in group B was 24 minutes. Group A had a success rate of 93.33%, while group B had a success rate of 87%. Post-operative complications occurred in 2 eyes in group B only.Conclusion:Both LTS with TRP and PS are effective in the management of involutional ectropion. LTS with TRP though more invasive has higher success rates and a lower incidence of complications as compared to PS. However, PS is an easy to perform out- patient procedure that is faster and better tolerated in old patients.

A prospective randomized pilot study of steroid modulation of cytokine (Interleukin 6) release in unilateral total knee replacement surgeries

Several studies evaluating the patients undergoing joint replacement have found elevation in the levels of cytokine interleukin-6(IL-6). High level of IL-6 after the major surgeries have been linked to postoperative fever, confusion, pain, acute respiratory distress syndrome, fat embolism syndrome. Pre and post-operative administration of low dose steroid (Inj. Hydrocortisone 100mg) in patients undergoing TKR has shown to reduce the inerleukin-6 level and its complications. The purpose of this study was to observe the effect of intravenous hydrocortisone on cytokine Interleukin-6 (IL-6) as primary outcome and also to observe presence of Fever, Blood sugar level (BSL), Pain score (using Visual analogue scale), Range of motion (ROM) and Spo2 (Saturation of oxygen) as a secondary outcome in the patients undergoing unilateral total knee arthroplasty. In our study 30 Patients were randomized into 2 groups. The study group received first dose of injection hydrocortisone 100mg I.V at the start of surgery followed by two more doses given eight hours apart while the control group received 100 ml of NS at similar intervals. From this study, we conclude that a low dose of hydrocortisone given for a short period of over 24 hours perioperatively to the patients having unilateral total knee arthroplasty are associated with decreased level of inflammatory marker, the cytokine Interleukin-6 (IL-6). The benefits included decrease pain scores, better saturation of oxygen (Spo2), lower prevalence of fever and better range of motion.