Uterine Evacuation before Operative Hysteroscopy in Patients with Active Uterine Bleeding: A randomized controlled trial

Abstract Background: Concurrent bleeding or existing clots usually obscure the vision field and decrease the hysteroscopy success rate. Therefore, any efforts made to have a clear view during the hysteroscopy will improve the diagnostic or treatment outcomes. In this study, we examined the effect of preoperative clot evacuation on hysteroscopy and patient outcomes.Methods: In this parallel-group clinical trial conducted from December 2018 to September 2019 at the Oncology Center of Alzahra Teaching Hospital in Tabriz, Iran, 114 patients with uterine bleeding were randomly assigned to receive either clot evacuation before standard operative hysteroscopy or standard hysteroscopy alone. The investigated endpoints were the clarity of vision, the volume of used distension media, duration of the procedure, amount of bleeding, and postoperative complications.Results: All 114 participants completed the study. There were statistically significant differences in the frequency of the clear vision (p<.001), the severity of bleeding (p=.0006), mean serum volume used (p<.001), mean procedure time (p<.001), and the postoperative hematocrit levels (p<.001) between groups, in favor of women with preprocedural intrauterine evacuation. There was no difference in in-hospital stay (p=0.081) and anesthetic complications among the patients (p=0.182). The procedure was successfully performed on all patients of both groups with zero postoperative complications.Conclusion: Removal of clots and other uterine contents before inserting hysteroscope rendered better and faster access to the uterine wall to observe existing abnormalities and reduce the hysteroscopy time. This additional surgical step could take a significant impact on surgical and clinical outcomes.Trial registration: Clinical trial registry name: Iranian Registry of Clinical Trials URL: https://en.irct.ir/trial/33369 The registration number: IRCT20101130005283N13 Date of trial registration: 2018-11-16

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Uterine Evacuation before Operative Hysteroscopy in Patients with Active Uterine Bleeding: A randomized controlled trial

10.21203/rs.3.rs-31109/v2 ◽

2020 ◽

Author(s):

Manizheh Sayyah-Melli ◽

Maryam Kazemi-Shishavan ◽

Nooshin Behravan ◽

Parvin Mostafa Gharabaghi ◽

Vahideh Rahmani

Keyword(s):

Postoperative Complications ◽

Controlled Trial ◽

Uterine Wall ◽

Uterine Bleeding ◽

Trial Registration ◽

Clinical Trial Registry ◽

Operative Hysteroscopy ◽

Registration Number ◽

Anesthetic Complications ◽

Clot Evacuation

Abstract Background: Concurrent bleeding or existing clots usually obscure the vision field and decrease the success rate of hysteroscopy. Therefore, any efforts made in order to have a clear view during the hysteroscopy will improve the diagnostic or treatment outcomes. We examined the effect of preoperative clot evacuation on hysteroscopy and patient outcomes. Methods: In this parallel-group trial, 114 patients with uterine bleeding were randomly assigned to receive either clot evacuation before standard operative hysteroscopy or standard hysteroscopy alone. The investigated endpoints were the clarity of vision, amount of bleeding, the volume of distension media, duration of the procedure, and postoperative complications. Results: All 114 participants completed the study. There were statistically significant differences in the frequency of the clear vision (p<.001), the severity of bleeding (p=.0006), mean procedure time (p<.001), mean serum volume used (p<.001), and the postoperative hematocrit levels (p<.001) between groups, in favor of women with preprocedural intrauterine evacuation. There was no difference related to in-hospital stay (p=0.081) and anesthetic complications among the patients (p=0.182). The procedure was successfully performed on all patients of both groups with zero postoperative complications. Conclusion: Removal of clots and other uterine contents before the insertion of the hysteroscope rendered better and faster access to the uterine wall to observe existing abnormalities. This additional surgical step could take a significant impact on surgical and clinical outcomes. Trial registration: Clinical trial registry name: Iranian Registry of Clinical Trials Url: https://en.irct.ir/trial/33369 The registration number: IRCT20101130005283N13 Date of trial registration: 2018-11-16

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Uterine Evacuation before Operative Hysteroscopy in Patients with Active Uterine Bleeding: A randomized controlled trial

10.21203/rs.3.rs-31109/v1 ◽

2020 ◽

Author(s):

Manizheh Sayyah-Melli ◽

Maryam Kazemi-Shishavan ◽

Nooshin Behravan ◽

Parvin Mostafa Gharabaghi ◽

Vahideh Rahmani

Keyword(s):

Controlled Trial ◽

Uterine Wall ◽

Uterine Bleeding ◽

Clinical Trial Registry ◽

Operative Hysteroscopy ◽

Clear Vision ◽

Parallel Group ◽

Registration Number ◽

Anesthetic Complications ◽

Clot Evacuation

Abstract BackgroundConcurrent bleeding or existing clots usually obscure the vision field and decrease the success rate in hysteroscopy. Therefore, any effort to have a clear view during the hysteroscopy will meliorate the diagnostic or treatment outcomes. We examined the effect of preoperative clot evacuation on hysteroscopy and patient outcomes.MethodsIn this parallel-group trial, 114 patients with uterine bleeding were randomly assigned to receive either clot evacuation before standard operative hysteroscopy or standard hysteroscopy alone. The primary endpoints were the clarity of vision, amount of bleeding, the volume of consumed media, duration of the procedure, and postoperative complications.ResultsAll 114 participants completed the study. There were statistically significant differences in the frequency of the clear vision (p < 0.001), the severity of bleeding (p = 0.0006), mean procedure time (p < 0.001), mean serum volume used (p < 0.001), and the postoperative hematocrit levels [95% CI (-3.00, -1.88)] (p < 0.001) between groups. There was no difference related to in-hospital stay (p = 0.081) and anesthetic complications among the patients (p = 0.182). The procedure was successfully performed on all patients of both groups with zero postoperative complications.ConclusionRemoval of clots and other uterine contents before the insertion of the hysteroscope rendered better and faster access to the uterine wall to observe existing abnormalities. This method of starting the hysteroscopy procedure has a significant impact on surgical outcomes.Trial registration: Clinical trial registry name: Iranian Registry of Clinical TrialsUrl: https://en.irct.ir/trial/33369The registration number: IRCT20101130005283N13Date of registration: 2018-11-16

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Naoxuekang, Xinnaoshutong and Xuesaitong capsules for treating stroke: a protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-015983 ◽

2017 ◽

Vol 7 (11) ◽

pp. e015983 ◽

Cited By ~ 2

Author(s):

Huiling Chen ◽

Hongbo Cao ◽

Xu Guo ◽

Meidan Zhao ◽

Qing Xia ◽

...

Keyword(s):

Clinical Trial ◽

Facial Paralysis ◽

Controlled Trial ◽

Clinical Trial Registry ◽

Double Blind ◽

Initial Treatment Period ◽

Double Blind Clinical Trial ◽

Registration Number ◽

Index Value ◽

Randomised Controlled

IntroductionAfter stroke, hemiplegia, dysphasia and facial paralysis can manifest during the convalescent period. Currently, no Chinese patent medicine (CPM) is previously reported to cure each of these symptoms primarily, and thus, there are no relevant instructions for the use of CPM. This study presents a new approach based on comparative effectiveness research to distinguish the curative effects of three CPMs that are often used in stroke convalescence to determine the ideal medicine for the treatment of each symptom.Methods and analysisIn this multicentre and double-blind clinical trial, stratified randomisation is used to group the patients according to their primary symptoms (hemiplegia, dysphasia and facial paralysis). Three strata will be enrolled, with 80 eligible participants included in each stratum. Each stratum will be randomly and equally divided into four groups, and each group will receive one of the following treatments: Naoxuekang, Xinnaoshutong (XNST), Xuesaitong (XST) or placebo. This study will include two stages: the initial treatment period (30 days) and a follow-up period (180 days). Three replicates for each data point will be completed during this trial. The first visit will occur on day 0 after enrolment, the second visit on day 30±2 and the third visit on day 210±5. The Delphi technique is adopted to achieve index weighting, which ensures that the evaluation outcome is patient oriented. The weighted index value will be computed as the final measurement index of the outcome.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of Tianjin University of Traditional Chinese Medicine (registration number TJUTCM-EC20160007). The results will be offered for publication in peer-reviewed journals.Trial registration numberThis trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17010397). The date of registration was 11 January 2017.

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Acupuncture Treatment for Symptom Management in Atopic Dermatitis: A Study Protocol for a Randomized, Participant- and Assessor-Blind, Sham-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/1907578 ◽

2019 ◽

Vol 2019 ◽

pp. 1-11 ◽

Cited By ~ 3

Author(s):

Jung Gun Park ◽

Hi-Joon Park ◽

Younbyoung Chae ◽

Yu-Kang Kim ◽

Hyangsook Lee ◽

...

Keyword(s):

Clinical Trial ◽

Atopic Dermatitis ◽

Acupuncture Treatment ◽

Controlled Trial ◽

Symptom Relief ◽

Sham Acupuncture ◽

Clinical Trial Registry ◽

Complementary And Alternative Therapies ◽

Registration Number

Atopic dermatitis (AD) is a chronic inflammatory skin disease with persistent itching, which impairs quality of life (QoL). Although various conventional treatments for AD exist, patients with AD often seek complementary and alternative therapies when conventional therapy has failed to relieve their AD symptoms or has had adverse effects. Acupuncture treatment may relieve AD symptoms, but controlled trials are needed to confirm this. Following our pilot study, which found that acupuncture treatment improves AD symptoms in mild-to-moderate AD patients, we will assess the effect of acupuncture treatment for symptom relief of AD using a trial with a complemented protocol. This is a two-arm, randomized, participant- and assessor-blinded, sham-controlled trial. A total of 36 mild-to-moderate AD patients will be randomly assigned in a 1:1 ratio to receive eight sessions twice weekly of either verum acupuncture (VA) or nonpenetrating sham acupuncture (SA) over four weeks. The primary outcome measured will be the change in the total Scoring Atopic Dermatitis (SCORAD) score. Secondary outcomes will be (1) changes in AD symptoms, QoL, dyspepsia symptoms, and electroencephalography (EEG) between baseline and week 4 and (2) changes in AD symptoms and QoL at baseline and at weeks 2, 4, and 8. This study will assess acupuncture treatment for the alleviation of AD symptoms in patients with mild-to-moderate AD. This clinical trial gas been registered in Korean Clinical Trial Registry (registration number: KCT0002796; date of registration: April 13, 2018).

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Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India

BMJ Open ◽

10.1136/bmjopen-2016-014851 ◽

2017 ◽

Vol 7 (8) ◽

pp. e014851 ◽

Cited By ~ 14

Author(s):

Dilip Jha ◽

Priti Gupta ◽

Vamadevan S Ajay ◽

Devraj Jindal ◽

Pablo Perel ◽

...

Keyword(s):

Public Health ◽

Cost Effectiveness ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

London School ◽

Clinical Trial Registry ◽

Link Type ◽

Adherence To Medication ◽

Cluster Randomised ◽

Registration Number

IntroductionRising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system.Methods and analysismWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness.Ethics and disseminationThe study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms.Trial registrationmWellcare trial is registered with Clinicaltrial.gov (Registration numberNCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org).

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Effects of daily L-dopa administration on learning and brain structure in older adults undergoing cognitive training: a randomised clinical trial

Scientific Reports ◽

10.1038/s41598-020-62172-y ◽

2020 ◽

Vol 10 (1) ◽

Cited By ~ 1

Author(s):

Alexander V. Lebedev ◽

Jonna Nilsson ◽

Joanna Lindström ◽

William Fredborg ◽

Ulrika Akenine ◽

...

Keyword(s):

Clinical Trial ◽

Cognitive Training ◽

Cognitive Aging ◽

Latent Variables ◽

Fluid Intelligence ◽

Controlled Trial ◽

Basic Research ◽

Clinical Trial Registry ◽

Double Blind ◽

Healthy Elderly

AbstractCognitive aging creates major individual and societal burden, motivating search for treatment and preventive care strategies. Behavioural interventions can improve cognitive performance in older age, but effects are small. Basic research has implicated dopaminergic signalling in plasticity. We investigated whether supplementation with the dopamine-precursor L-dopa improves effects of cognitive training on performance. Sixty-three participants for this randomised, parallel-group, double-blind, placebo-controlled trial were recruited via newspaper advertisements. Inclusion criteria were: age of 65–75 years, Mini-Mental State Examination score >25, absence of serious medical conditions. Eligible subjects were randomly allocated to either receive 100/25 mg L-dopa/benserazide (n = 32) or placebo (n = 31) prior to each of twenty cognitive training sessions administered during a four-week period. Participants and staff were blinded to group assignment. Primary outcomes were latent variables of spatial and verbal fluid intelligence. Compared to the placebo group, subjects receiving L-dopa improved less in spatial intelligence (−0.267 SDs; 95%CI [−0.498, −0.036]; p = 0.024). Change in verbal intelligence did not significantly differ between the groups (−0.081 SDs, 95%CI [−0.242, 0.080]; p = 0.323). Subjects receiving L-dopa also progressed slower through the training and the groups displayed differential volumetric changes in the midbrain. No statistically significant differences were found for the secondary cognitive outcomes. Adverse events occurred for 10 (31%) and 7 (23%) participants in the active and control groups, correspondingly. The results speak against early pharmacological interventions in older healthy adults to improve broader cognitive functions by targeting the dopaminergic system and provide no support for learning-enhancing properties of L-dopa supplements in the healthy elderly. The findings warrant closer investigation about the cognitive effects of early dopamine-replacement therapy in neurological disorders. This trial was preregistered at the European Clinical Trial Registry, EudraCT#2016-000891-54 (2016-10-05).

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Weekly iron–folic acid supplements containing 2.8 mg folic acid are associated with a lower risk of neural tube defects than the current practice of 0.4 mg: a randomised controlled trial in Malaysia

BMJ Global Health ◽

10.1136/bmjgh-2020-003897 ◽

2020 ◽

Vol 5 (12) ◽

pp. e003897

Author(s):

Kaitlyn L I Samson ◽

Su Peng Loh ◽

Siew Siew Lee ◽

Dian C Sulistyoningrum ◽

Geok Lin Khor ◽

...

Keyword(s):

Folic Acid ◽

Neural Tube ◽

Controlled Trial ◽

Clinical Trial Registry ◽

Double Blind ◽

Folic Acid Supplements ◽

Registration Number ◽

Menstruating Women ◽

Iron Folic Acid ◽

Randomised Controlled

IntroductionWeekly iron–folic acid (IFA) supplements are recommended for all menstruating women in countries where anaemia prevalence is >20%. Anaemia caused by folate deficiency is low worldwide, and the need to include folic acid is in question. Including folic acid might reduce the risk of a neural tube defect (NTD) should a woman become pregnant. Most weekly supplements contain 0.4 mg folic acid; however, WHO recommends 2.8 mg because it is seven times the daily dose effective in reducing NTDs. There is a reluctance to switch to supplements containing 2.8 mg of folic acid because of a lack of evidence that this dose would prevent NTDs. Our aim was to investigate the effect of two doses of folic acid, compared with placebo, on red blood cell (RBC) folate, a biomarker of NTD risk.MethodsWe conducted a three-arm double-blind efficacy trial in Malaysia. Non-pregnant women (n=331) were randomised to receive 60 mg iron and either 0, 0.4, or 2.8 mg folic acid once weekly for 16 weeks.ResultsAt 16 weeks, women receiving 0.4 mg and 2.8 mg folic acid per week had a higher mean RBC folate than those receiving 0 mg (mean difference (95% CI) 84 (54 to 113) and 355 (316 to 394) nmol/L, respectively). Women receiving 2.8 mg folic acid had a 271 (234 to 309) nmol/L greater mean RBC folate than those receiving 0.4 mg. Moreover, women in the 2.8 mg group were seven times (RR 7.3, 95% CI 3.9 to 13.7; p<0.0001) more likely to achieve an RBC folate >748 nmol/L, a concentration associated with a low risk of NTD, compared with the 0.4 mg group.ConclusionWeekly IFA supplements containing 2.8 mg folic acid increases RBC folate more than those containing 0.4 mg. Increased availability and access to the 2.8 mg formulation is needed.Trail registration numberThis trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12619000818134).

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Revisit the Effectiveness of Educational Kinesiology on Stress and Anxiety Amelioration in Kindergarteners With Special Needs: A Nonrandomized Trial

10.21203/rs.3.rs-407301/v1 ◽

2021 ◽

Author(s):

Pui Lun Alan TAI ◽

Kwok Wai Way LAU

Keyword(s):

Clinical Trial ◽

Special Needs ◽

Scientific Evidence ◽

Intervention Group ◽

Control Group ◽

Clinical Trial Registry ◽

Open Label ◽

Post Intervention ◽

Educational Kinesiology ◽

Registration Number

Abstract Although educational kinesiology is a popular intervention aims to improve brain functioning via physical movements, it lacks supporting scientific evidence. This study explores the effect of educational kinesiology on the changes in stress and anxiety markers in kindergarteners with special needs using psychometrics and biological measures. This open label non-randomized clinical trial was registered retrospectively in the Chinese Clinical Trial Registry (registration number: ChiCTR2000036305, url: http://www.chictr.org.cn/showproj.aspx?proj=58067, registration date: 22/08/2020). Thirty-seven kindergarteners with special needs (3.5-6.5 years old) were assigned to either the intervention group, which received one-hour educational kinesiology intervention weekly for a total of 10 weeks, or the wait-list control group. Scores of Parent-rated Preschool Anxiety Scale (PAS-TC), salivary cortisol and oxytocin levels were obtained pre- and post-intervention. After controlling baseline, the changes in oxytocin levels remained significantly different between groups (F1,35 = 5.590, p = 0.020, eta2 = 0.145), but not in cortisol levels (F1,35 = 0.364, p = 0.550, eta2 = 0.01). PAS-TC showed significant improvement in anxiety levels after the intervention in the intervention group (X2 = 4.367, p = 0.037, φ = 0.344, p = 0.037). Findings from both subjective and objective measures indicate a plausible anti-stress and anxiety effect in kindergarteners with special needs.

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Eating self-efficacy changes in individuals with type 2 diabetes following a structured lifestyle intervention based on the transcultural Diabetes Nutrition Algorithm (tDNA): A secondary analysis of a randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0242487 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0242487

Author(s):

Harvinder Kaur Gilcharan Singh ◽

Winnie Siew Swee Chee ◽

Osama Hamdy ◽

Jeffrey Ian Mechanick ◽

Verna Kar Mun Lee ◽

...

Keyword(s):

Type 2 Diabetes ◽

Clinical Trial ◽

Weight Loss ◽

Motivational Interviewing ◽

Lifestyle Intervention ◽

Self Efficacy ◽

Controlled Trial ◽

Secondary Analysis ◽

Registration Number

Objective Eating self-efficacy behavior is an important predictor of successful lifestyle intervention. This secondary analysis evaluated the changes in eating self-efficacy behavior in patients with type 2 diabetes (T2D) and overweight/obesity following structured lifestyle intervention based on the Malaysian customized transcultural Diabetes Nutrition Algorithm (tDNA). Methods Patients with T2D and overweight/obesity (n = 230) were randomized either into the tDNA group which included a structured low-calorie meal plan using normal foods, incorporation of diabetes-specific meal replacements, and an exercise prescription or usual T2D care (UC) for 6 months. Patients in the tDNA group also received either counseling with motivational interviewing (tDNA-MI) or conventional counseling (tDNA-CC). The UC group received standard dietary and exercise advice using conventional counseling. Eating self-efficacy was assessed using a locally validated Weight Efficacy Lifestyle (WEL) questionnaire. All patients were followed up for additional 6 months’ post-intervention. Results There was a significant change in WEL scores with intervention over one-year [Group X Time effect: F = 51.4, df = (3.4, 318.7), p<0.001]. Compared to baseline, WEL scores improved in both the tDNA groups with significantly higher improvement in the tDNA-MI group compared to the tDNA-CC and UC groups at 6 months (tDNA-MI: 25.4±2.1 vs. tDNA-CC: 12.9±2.8 vs. UC: -6.9±1.9, p<0.001). At 12 months’ follow-up, both the tDNA groups maintained improvement in the WEL scores, with significantly higher scores in the tDNA-MI group than tDNA-CC group, and the UC group had decreased WEL scores (tDNA-MI: 28.9±3.1 vs. tDNA-CC: 11.6±3.6 vs. UC: -13.2±2.1, p<0.001). Patients in the tDNA-MI group with greater weight loss and hemoglobin A1C reduction also had a higher eating self-efficacy, with a similar trend observed in comparative groups. Conclusion Eating self-efficacy improved in patients with T2D and overweight/obesity who maintained their weight loss and glycemic control following a structured lifestyle intervention based on the Malaysian customized tDNA and the improvement was further enhanced with motivational interviewing. Clinical trial This randomized clinical trial was registered under National Medical Research Registry, Ministry of Health Malaysia with registration number: NMRR-14-1042-19455 and also under ClinicalTrials.gov with registration number: NCT03881540.

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Pressure Dressings Versus Nonpressure Dressings After Hemorrhoidectomy: Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-487275/v1 ◽

2021 ◽

Author(s):

Ping Xue ◽

Jing Wu ◽

Ping Zhu ◽

Dan Wang ◽

Mei Xu ◽

...

Keyword(s):

Postoperative Complications ◽

Urinary Retention ◽

Controlled Trial ◽

Postoperative Bleeding ◽

Clinical Trial Registry ◽

Skin Injury ◽

Open Hemorrhoidectomy ◽

Randomized Clinical Study ◽

Primary Endpoints ◽

Medical Adhesive

Abstract BackgroundPressure dressings have been used after open hemorrhoidectomy to protect surgical wounds and manage postoperative bleeding for many years. However, pressure dressings may increase the incidence of postoperative complications, such as urinary retention, medical adhesive-related skin injury, and pain. A previous controlled trial included 67 patients who underwent Milligan-Morgan hemorrhoidectomy. The data indicated that the use of a nonpressure dressing after hemorrhoidectomy reduces the incidence of urinary retention and catheterization. However, the incidence of severe postoperative bleeding and other postoperative complications was not assessed. There is no consensus on whether it is necessary and beneficial to use a nonpressure dressing after hemorrhoidectomy. The results of this randomized clinical study will help answer this question.MethodsIn this study, we plan to include 186 patients who have undergone Milligan-Morgan hemorrhoidectomy. The purpose is to determine whether the use of nonpressure dressings after open hemorrhoidectomy is inferior to the use of pressure dressings in terms of severe postoperative bleeding and postoperative complications. The primary endpoints of the trial are the incidence of urinary retention within 24 hours after surgery and the incidence of severe postoperative bleeding one hour after dressing removal, which requires revision surgery within 24 hours after the surgery. The secondary endpoints of the study are the pain score, anal distension score, postoperative use of analgesics, and incidence of medical adhesive-related skin injury, all of which will be assessed before removing the dressings. The length of hospitalization in days and hospitalization expenses will be recorded. Safety will be assessed with consideration of all adverse and severe adverse events related to the study treatment.DiscussionThe study received full ethics committee approval. The first patient was enrolled on 27 November 2020. The results of this trial will finally answer the question of whether a nonpressure dressing after open hemorrhoidectomy is necessary and beneficial.Trial registrationChinese Clinical Trial Registry (registration ID: ChiCTR2000040283). Registered on 28 November. 2020. {2} http://www.chictr.org.cn/edit.aspx?pid=58894&htm=4 {2b}

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