Complications after Stapled Hemorrhoidectomy: A Single Center Experience

Background: A circumferential strip of mucosa about 1.5 to 2 centimetres above the dentate line is removed in stapled hemorrhoidectomy, a new technique for haemorrhoids treatments. Objective: The aim of the study was to evaluate complications after stapled hemorrhoidectomy.Methods:A total of 101 patients between the age group 20 to 70 years were diagnosed with grade 3 and grade 4 haemorrhoids. Patients are included in stapled haemorrhoidectomy. The questionnaire focused on stapled hemorrhoidectomy procedures performed in the period July 2018 to June 2020. Descriptive analysis was done based on the student’s T-test using SPSS 24 software version. The level of significance was set at 5% (p < 0.05).Results:In the 2-years timeframe, out of 101 patients in the Immediate (within 1 week) complications of stapled hemorrhoidectomy, 84.16% were in None, 5.94% were severe pain, 3.96% were bleeding, 1.98% were Thrombosis, 0.99% were urinary retention, 1.98% were Anastomotic dehiscence 0.99% were Fissure, 0.99% were perineal intramural hematoma and 0.99% were submucosal abscess. Out of 90.09% were in none, 1.98% were Recurrent hemorrhoids, 0.99% were Severe pain, Stenosis, Fissure, Skin tag, Thrombosis, Staples problems, Intramural abscess and Intussusception.Conclusion:Although stapled hemorrhoidectomy appears to be promising, we believe that a multicenter randomized controlled trial with a long-term follow-up comparing stapled hemorrhoidectomy and banding is required before the treatment can be recommended. The majority of difficulties can be avoided by following the rectal wall anatomy during the surgery.

Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

Background Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such as glaucoma, blindness, and other complications. At present, the solutions for myopia are glasses, medication, and surgery. This study aims to investigate the role of a physiotherapy category based on guided meditation for vision acuity training on adolescent myopia. Methods This is a prospective, randomized, multicenter clinical trial. One thousand one hundred forty primary and secondary school students aged 8–18 years old from 27 schools will be recruited and randomly divided into an experimental and a control group at a ratio of 2:1 in two phases, with a training period of 30 days in each phase and a follow-up period of 3 months. No interventions will be conducted during the follow-up period, nor will other interventions employed. Inclusion criteria will meet the diagnostic criteria for simple myopia and −6.00D ≤ spherical lenses ≤ −0.50D and cylindrical lenses ≤1.50D. The primary observation index will be to compare the statistical differences in distant visual acuity between the two groups; the secondary observation indexes will be ocular symptoms (mainly including eye fatigue, dryness, pain, double vision, neck pain, thought disorders, and lags in response), diopter, and astigmatism. Discussion The purpose of this two-phase trial is to compare the clinical effectiveness of focused vision-guided meditation with Chinese eye exercises that are also non-pharmacological, non-invasive interventions for myopia, and to maximize the benefit to the subjects. The results will indicate whether the training based on focused vision-guided meditation has the ability to improve distant visual acuity, relieve ocular symptoms, and ameliorate diopter. In addition, this trial will provide clinical efficacy of the training, which is expected to provide meaningful data for vision rehabilitation. At the same time, the vision acuity training method, which is permeated with the concept of Traditional Chinese Medicine (TCM) rehabilitation and health maintenance, will be applied to achieve the goal of preventing or alleviating myopic development and reducing myopia rate. Trial registration Chinese Clinical Trial Registry ChiCTR2000038642. Registered on 26 September 2020

Fasting before living-kidney donation: effect on donor well-being and postoperative recovery: study protocol of a multicenter randomized controlled trial

Background One of the main effectors on the quality of life of living-kidney donors is postoperative fatigue. Caloric restriction (CR) and short-term fasting (STF) are associated with improved fitness and increased resistance to acute stress. CR/STF increases the expression of cytoprotective genes, increases immunomodulation via increased anti-inflammatory cytokine production, and decreases the expression of pro-inflammatory markers. As such, nutritional preconditioning by CR or STF represents a non-invasive and cost-effective method that could mitigate the effects of acute surgery-induced stress and postoperative fatigue. To investigate whether preoperative STF contributes to a reduction in fatigue after living-kidney donation, a randomized clinical trial is indicated. Methods We aim to determine whether 2.5 days of fasting reduces postoperative fatigue score in subjects undergoing living-kidney donation. In this randomized study, the intervention group will follow a preoperative fasting regime for 2.5 days with a low-dose laxative, while the control group will receive standard care. The main study endpoint is postoperative fatigue, 4 weeks after living-kidney donation. Secondary endpoints include the effect of preoperative fasting on postoperative hospital admission time, the feasibility of STF, and the postoperative recovery of donor and recipient kidney function. This study will provide us with knowledge of the feasibility of STF and confirm its effect on postoperative recovery. Discussion Our study will provide clinically relevant information on the merits of caloric restriction for living-kidney donors and recipients. We expect to reduce the postoperative fatigue in living-kidney donors and improve the postoperative recovery of living-kidney recipients. It will provide evidence on the clinical merits and potential caveats of preoperative dietary interventions. Trial registration Netherlands Trial Register NL9262. EudraCT 2020-005445-16. MEC Erasmus MC MEC-2020-0778. CCMO NL74623.078.21

Diagnostic ability of linked color imaging in ultraslim endoscopy to identify neoplastic lesions in the upper gastrointestinal tract

Background and study aims Linked color imaging (LCI) is a new image-enhancing technique that facilitates the differentiation of slight differences in mucosal color tone. We performed an exploratory analysis to evaluate the diagnostic capability of LCI in ultraslim endoscopy, using data from patients examined in the LCI-Further Improving Neoplasm Detection in upper gastrointestinal (LCI-FIND) trial, a large-scale, multicenter, randomized controlled trial that demonstrated the capability of LCI for detecting neoplastic lesions in the upper gastrointestinal tract. Patients and methods Data from the LCI-FIND prospective trial were used. In the LCI-FIND trial, 1502 patients with a history of gastrointestinal cancer were randomly assigned to two groups based on examination methods: white light imaging (WLI) followed by LCI (WLI group) and LCI followed by WLI (LCI group). The present exploratory analysis investigated the outcomes of patients who underwent ultraslim and standard endoscopies. Results Ultraslim endoscopes were used in 223 patients and standard endoscopes in 1279 patients. The primary endpoint of the LCI-FIND trial was the percentage of patients diagnosed with a neoplastic lesion using WLI or LCI. The corresponding percentage tended to be higher with LCI than with WLI among patients who underwent ultraslim endoscopy and among those who underwent standard endoscopy; the crude risk ratio was 2.21 [95 % confidence interval (CI): 1.06–4.67], and the adjusted odds ratio was 2.46 (95 % CI: 1.07–5.63). Conclusions Our exploratory analysis of data from the LCI-FIND trial showed that LCI is useful in identifying neoplastic lesions, when used in ultraslim endoscopy.

RENaBack: low back pain patients in rehabilitation—study protocol for a multicenter, randomized controlled trial

Background Millions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country. Methods The aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG). Discussion An improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers. Trial registration DRKS, DRKS00020373. Registered on 15 April 2020