scholarly journals Modified tissue-selecting therapy stapler combined with complete anal canal epithelial preservation operation for the treatment of circumferential mixed haemorrhoids: a protocol for single-blind randomised controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e052982
Author(s):  
Hua Huang ◽  
Yunfei Gu ◽  
Youran Li ◽  
Lijiang Ji

IntroductionThis protocol designed a randomised controlled trial (RCT) to evaluate the effectiveness, safety and prognostic outcomes of modified tissue selecting technique (M-TST) combined with complete anal canal epithelial preservation (CACP) among patients with circumferential mixed haemorrhoids.Methods and analysisThis study will be single-blinded, and recruit 348 patients who are admitted to the Changshu Hospital Affiliated to Nanjing University of Chinese Medicine and fulfil the inclusion criteria from January 2022 to December 2022. Patients will be randomly assigned to the treatment group and the control group in a 1:1 ratio. The statistician will be blinded for the allocation. The treatment group will receive M-TST combined with CACP (M-TST–CACP), while the control group will receive the procedure for prolapse and haemorrhoids. The two groups will receive the same preoperative and postoperative care. The primary outcome will be recurrence rate. The secondary outcomes will be operation time, intraoperative bleeding, incontinence, pain, postoperative complications (severe bleeding, perianal oedema, urinary retention, faecal urgency, skin tags and anal stenosis), prolapse, recovery time, quality of life, Haemorrhoid Severity Score, and Symptom Severity Score.Ethics and disseminationThis protocol has been approved by the Clinical Ethics Committee of the Changshu Hospital Affiliated to Nanjing University of Chinese Medicine (approval no. 202102001).Trial registration numberChiCTR2100042750.

Author(s):  
Hua HUANG ◽  
Yunfei GU ◽  
Lijiang JI ◽  
Youran LI ◽  
Shanshan XU ◽  
...  

ABSTRACT Background: Varicose veins appear above and below the dentate line in mixed hemorrhoids, which seriously affects anal function and quality of life. Aim: To propose an improvement in tissue-selecting therapy repair of anal pad combined with complete anal canal epithelial retention comparing with Milligan-Morgan surgery. Methods: A prospective randomized controlled study was designed enrolling 200 patients with grade III and IV hemorrhoids. They were divided into control and observation groups. The control received Milligan-Morgan surgery, and the observation the modified tissue-selecting therapy stapler combined with complete anal canal preservation surgery. All patients were followed for six months to evaluate the treatment differences. Results: In final, control group included 82 and observation 87. The average operation time of the control group was significantly lower than that of the observation, while the bleeding volume was significantly lower in control group. The control group VAS score was 3 (1, 4), and observation 4 (2, 5). There was no significant difference in the incidence of urinary retention, bleeding and wound margin edema after surgery at one month postoperatively. Digital incidence of anal stenosis in the observation group was significantly lower than in control; the same occurred with residual anal margins. The postoperative anal canal diameter was significantly larger than the control group. Wexner anal incontinence score showed that no anal incontinence occurred in both groups, and the control group scored was significantly higher than observation. In final six months follow-up, the observation group did not experience any relapse and four cases were found among controls. The treatment satisfaction of the observation group was better. Conclusions: In grades III and IV hemorrhoids, modified tissue-selecting therapy combined with complete anal canal preservation had better prognosis and treatment satisfaction than Milligan-Morgan procedure, and it is a new surgical method for patients with advanced mixed hemorrhoids.


2020 ◽  
Vol 29 (11) ◽  
pp. 664-668
Author(s):  
Robabeh Abedini ◽  
Hamidreza Mahmoudi ◽  
Soheila Kordestani ◽  
Farzaneh Nayeb Habib ◽  
Mitra Abyaneh ◽  
...  

Objective: To examine the effect of a nanocolloidal silver-based gel called SilvoGel (ChitoTech, Iran) versus eosin (prepared by Razi Hospital, Iran) among patients with immunobullous disease. Method: This blind, randomised controlled study was carried out on patients with pemphigus vulgaris who had hard-to-heal ulcers, divided into two equal-sized groups: one treatment group receiving the nanocolloidal silver-based gel and the control group receiving the conventional eosin. Results: A total of 32 patients participated in the study. In both the treatment and control groups, ulcer area, exudate and tissue type improved significantly (p<0.001 for all measures). A significantly higher rate of improvement in ulcer area was observed in the treatment group compared with the control group (p<0.001). Both patient and physician satisfaction were significantly higher in the treatment group compared with the control group (p=0.003 and p=0.01, respectively). Conclusion: The results of this study indicate that use of the nanocolloidal silver-based gel for treating patients with immunobullous disease including pemphigus could potentially increase the rate and quality of wound healing.


Author(s):  
Ruihuan Pan ◽  
Shanshan Ling ◽  
Haodong Yang ◽  
Yan Huang ◽  
Lechang Zhan ◽  
...  

Background: Shoulder-hand syndrome (SHS) refers to a syndrome causing sudden edema, shoulder pain and limited hand function. Qingpeng ointment, a kind of Tibetan medicine, can reduce swelling, relieve pain, tonify stagnation and clear the meridians, which is consistent with the pathological mechanism of SHS after stroke. Therefore, if clinical trials can be used to explore the effectiveness of Qingpeng ointment for treatment of poststroke SHS and promote its application in clinical medicine, this is of specific significance for the treatment of poststroke SHS. Objective: To investigate the clinical efficacy and safety of Qingpeng ointment in the treatment of poststroke SHS. To provide an objective basis for a better therapeutic treatment for poststroke SHS. Method: A prospective, randomized, controlled study was conducted. This study recruited 120 patients with poststroke SHS who met the inclusion criteria. They were randomized into the treatment group and the control group, with 60 patients allocated to each group. The treatment group received routine medical treatment and rehabilitative care after using the Qingpeng ointment, while the patients in the control group received only routine treatment without the ointment. All patients received clinical assessment with the Visual Analogue Scale (VAS), measurement of the range of motion (ROM) of the upper-limb joints, the Fugl-Meyer Assessment of Upper Extremity (FMA-U) and the Modified Barthel Index Score (MBI) before and after the whole treatment. Results: After 4 weeks of treatment, the VAS scores of both groups were decreased significantly (P<0.05), and the difference between the two groups was statistically significant (P < 0.05). There is no statistical significance for the difference between the treatment group and control group in terms of the FMA-U and MBI scores and the forward bend, backward, outstretch, external rotation and pronation angles after treatment. The increases in the values of VAS, FMA-M and MBI in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). The increases in the values of the forward bend, outreach and external rotation angles in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). Conclusion: The treatment group showed better results than the control group in terms of the relief of pain symptoms, the improvement of motor function and the improvement of the activities of daily living for patients with shoulder-hand syndrome after cerebral hemorrhage. Qingpeng ointment is effective and safe in treating poststroke SHS.


2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Li-Yao Duan ◽  
Yan Liang ◽  
Wen-Ping Gong ◽  
Yong Xue ◽  
Jie Mi ◽  
...  

Abstract Background The traditional Chinese medicine NiuBeiXiaoHe (NBXH) extract and Chinese medicine preparation JieHeWan (JHW) exhibit anti-tuberculosis effects. The anti- tuberculosis effect of NBXH was compared with that of JHW to elucidate the mechanism of action of NBXH. Methods BALB/c mice aged 6-8 weeks were randomly divided into a normal control group, Tuberculosis (TB) model group, JHW treatment group, and NBXH treatment group. After 3 and 13 weeks of treatment, the therapeutic effect in each group was evaluated by comparing lung histopathology, lung and liver colony counts, the number of spots representing effector T cells secreting IFN-γ in an ELISPOT, and the levels of Th1, Th2, and Th17 cytokines, which were measured by a cytometric bead array (CBA). Mouse RNA samples were subjected to transcriptome sequencing. Results After 13 weeks of treatment, the mean histopathological lesion area of the NBXH group was significantly smaller than that of the TB model group (P < 0.05). Compared with those in the TB model group, the lung colony counts in the JHW and NBXH groups were significantly decreased (P < 0.05), and the IL-2 and IL-4 levels in the NBXH group were significantly increased (P < 0.05). NBXH partly restored significant changes in gene expression caused by Mycobacterium tuberculosis (M. tuberculosis) infection. According to GO and KEGG analyses, the changes in biological process (BP), cell composition (CC) and molecular function (MF) terms and in signaling pathways caused by NBXH and JHW treatment were not completely consistent, but they were mainly related to the immune response and inflammatory response in the mouse TB model. Conclusions NBXH had therapeutic effects similar to those of JHW in improving lung histopathology, reducing lung colony counts, and regulating the levels of cytokines. NBXH restored significant changes in gene expression and repaired cell damage caused by M. tuberculosis infection by regulating immune-related pathways, which clarified the mechanism of action of NBXH.


Author(s):  
E Ocak ◽  
S Mulazimoglu ◽  
D Kocaoz ◽  
E Mirici ◽  
E Dagli ◽  
...  

Abstract Objective To investigate the effects of nasal irrigation with sodium hyaluronate and surfactant solutions on mucociliary clearance time in patients with mild persistent allergic rhinitis. Methods A total of 120 patients diagnosed with mild persistent allergic rhinitis were enrolled in this prospective study. The patients were allocated randomly to the surfactant, sodium hyaluronate or isotonic saline (as a control) nasal irrigation group. The mucociliary clearance times and improvements in mucociliary clearance times were compared. Results Improvements in mean mucociliary clearance time were significantly greater in the surfactant and sodium hyaluronate groups than in the control group (p < 0.01). The mean post-treatment mucociliary clearance time of the surfactant group was significantly lower than that of the control (p < 0.001) and sodium hyaluronate groups (p = 0.03). Conclusion Surfactant and sodium hyaluronate nasal irrigation solutions may both be used as adjunctive treatments for allergic rhinitis. Surfactant nasal irrigation resulted in better mucociliary clearance times.


2017 ◽  
Vol 17 (2) ◽  
pp. 444-450 ◽  
Author(s):  
Cong Wang ◽  
Peiguo Wang ◽  
Huaqiang Ouyang ◽  
Jing Wang ◽  
Lining Sun ◽  
...  

Objective: To estimate the efficacy of traditional Chinese medicine (Chining decoction, CHIN) for radiation-induced oral mucositis in patients with head and neck cancer. Methods: From May 2014 to December 2015, 70 consecutive patients were randomly assigned to receive CHIN (treatment group) or recombinant human epidermal growth factor (rhEGF) spray (control group) at a 1:1 ratio. CHIN was administered to treatment group from the first day of radiotherapy until the completion of radiotherapy. Simultaneously, the rhEGF spray was administered to control group on the oral mucosa of irradiated area. The clinical benefit was determined by gradation of mucositis (Common Terminology Criteria for Adverse Events v4.0), oral pain, and xerostomia (visual analysis scale) for each week during radiotherapy. Body mass index was evaluated before and after radiotherapy. Results: Patients in the treatment group had prominent remission of oral pain and grade of mucositis on each observing point compared with those in control group ( P < .01). Xerostomia was decreased notably in treatment group compared with control group ( P < .01). Body mass index in the treatment group exhibited advantage over control group after radiotherapy, but there was no statistical significance (19.8 ± 3.26 vs 18.8 ± 2.5 kg/m2, P = .153, >.05). Conclusions: CHIN presented an obvious advantage in preventing radiation-induced oral mucositis compared with rhEGF spray.


1993 ◽  
Vol 163 (1) ◽  
pp. 49-54 ◽  
Author(s):  
Tom Burns ◽  
Alan Beadsmoore ◽  
Ashok V. Bhat ◽  
Andrew Oliver ◽  
Carola Mathers

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).


2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Alice Kongsted ◽  
Tue Secher Jensen ◽  
Klaus Doktor ◽  
Lise Hestbæk

Abstract Background Disease monitoring is an important element of self-management of several chronic diseases. Pain monitoring has become very easily available, but the role in musculoskeletal pain conditions is not clear. Awareness of pain might be helpful for people to understand pain, but focusing on pain may on the contrary negatively affect pain experience and behaviours. The objective of this study was to investigate the potential impact of pain monitoring on low back pain (LBP), specifically to determine if pain intensity, activity limitation and pain control, differed between patients with weekly pain monitoring over 12 months and patients with follow-ups at 2 weeks, 3 months and 12 months. Methods This was a non-randomised controlled study embedded in a cohort study with data collection November 1st 2016 to December 21st 2018. Adults seeking care for LBP were enrolled at the first visit to a chiropractor and followed with surveys after 2 weeks, 3 months and 12 months. Those enrolled first, n = 1,623, furthermore received weekly SMS-questions about pain frequency and pain intensity, whereas those enrolled next was the control group, n = 1,269 followed only by surveys. Outcomes at 12-months were compared, adjusting for group differences on baseline parameters. Results LBP intensity (0–10) was slightly lower at 12-months follow-up in the SMS group than the control group (adjusted beta − 0.40 (95% CI: − 0.62; − 0.19)). No relevant between-group differences were observed for activity limitation (0–100) (1.51 (95% CI: − 0.83; 3.85)) or ability to control pain (0–10) (− 0.08 (95% CI − 0.31; 0.15)). Conclusions Frequent pain monitoring did not demonstrate any negative effects of weekly pain monitoring, and it was perhaps even helpful. The role of self-monitoring as part of self-managing LBP should be explored further including optimal frequencies, formats, and methods for feedback. Trial registration The study was not registered as a clinical trial.


2020 ◽  
Vol 19 ◽  
pp. 153473542092483
Author(s):  
Yan Mei Peng ◽  
Hua Duan ◽  
Jingyi Zhang ◽  
Chenyao Sun ◽  
Xu Zhang ◽  
...  

Background: Dermatologic toxicities are the most common side effects associated with the targeted drugs epidermal growth factor receptor inhibitors (EGFRIs), in which xerosis commonly complicated by pruritus severely disturbs the quality of life. The study has observed the curative effect of Zizao Yangrong granules (ZYG) from Chishui Xuanzhu in the treatment of EGFRIs-related xerosis and pruritus, as well as evaluating the safety of the prescription. Methods: Patients (n = 68) who had xerosis after using EGFRIs were enrolled and then randomly divided into the treatment group and control group, respectively, receiving ZYG and placebo granules combined with vitamin E ointment. The intervention lasted 4 weeks. Changes in xerosis and pruritus were observed, and blood routine examination as well as liver and kidney function are observed as safety indexes. The water content of skin and qualify of life were observed. Results: A total of 66 out of 68 patients finished the study with 34 patients in each group. The effective rates of xerosis among the treatment group and control group were 84.8% and 69.7% after 2 weeks’ treatment ( P < .05), while they were 84.8% and 75.8% after 4 weeks’ treatment ( P < .05). The patients in the experimental group had better quality of life than that in the control group ( P = .045). Conclusion: ZYG can effectively improve the skin dryness associated with EGFRIs, and significantly improve the quality of life of patients with good safety; however, larger randomized controlled trials are needed to verify these findings.


2018 ◽  
Vol 36 (2) ◽  
pp. 71-79 ◽  
Author(s):  
Hai-Qiao Wang ◽  
Gui-Rong Dong ◽  
Chun-Ling Bao ◽  
Zhi-Hua Jiao

Objective To investigate the immediate effect of scalp acupuncture on walking pattern, using three-dimensional gait analysis (3D-GA), among patients in the subacute stage of intracerebral haemorrhage (ICH). Methods A subset of 30 patients with subacute ICH participating in a recently published randomised controlled trial who were able to walk independently were assessed by 3D-GA before and immediately after scalp acupuncture treatment (treatment group) or no intervention (control group) and the results presented here as a secondary analysis. The acupuncture manipulation was repeated three times with an interval of 5 min. Spatiotemporal and kinematic parameters during walking were collected and analysed using a 3D motion analysis system. Results After treatment, there were significant differences between the treatment and control groups in the spatiotemporal parameters of step length, velocity and cadence (p<0.05) and double-limb support. No significant difference was found in step width. When kinematic parameters were evaluated, the treatment group showed a significantly decreased peak pelvic anterior tilt angle and an increased hip extension angle after scalp acupuncture treatment, whereas the control group demonstrated no temporal changes. There were no significant changes in any other kinematic parameters in either group. Conclusions As the first exploratory study to investigate the effect of the scalp acupuncture on gait performance in patients with subacute ICH, this secondary analysis of a recent randomised trial suggested an immediate effect of treatment on spatiotemporal parameters. Improvement in gait pattern may be associated with a decreased anterior tilt of the pelvis and augmented hip joint motion during walking. Trial Registration Number ChiCTR-TRC-08000225; Post-results.


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