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

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}

scholarly journals Pressure dressings versus nonpressure dressings after hemorrhoidectomy: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
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 Background Pressure 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. Methods In this study, we plan to include 186 patients who have undergone modified Milligan-Morgan hemorrhoidectomy, which only sutured external hemorrhoids to reduce the risk of bleeding. 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 h after surgery and the incidence of severe postoperative bleeding 1 h after dressing removal, which requires revision surgery within 24 h 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. Discussion The 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 registration Chinese Clinical Trial Registry ChiCTR2000040283. Registered on 28 November 2020.

scholarly journals A comparative study of Lichtenstein hernioplasty performed under spinal anaesthesia versus local anaesthesia in treatment of unilateral inguinal hernia

2019 ◽  
Vol 6 (10) ◽  
pp. 3773
Author(s):  
Siddhabrata Besra ◽  
Pradip Kumar Mohanta ◽  
Chinmoy Mallik ◽  
Noor Hassan Hussian ◽  
Subikash Biswas ◽  
...  
Keyword(s):  
Inguinal Hernia ◽  
Postoperative Pain ◽  
Postoperative Complications ◽  
Comparative Study ◽  
Urinary Retention ◽  
Spinal Anaesthesia ◽  
Local Anaesthesia ◽  
Standard Procedure ◽  
Lichtenstein Hernioplasty ◽  
Randomized Clinical Study

Background: Lichtenstein mesh repair technique is widely used throughout the world in inguinal hernia repair. Hernioplasty done under local anaesthesia certainly has some benefits but it is yet to be proven as standard procedure. The aims of this study are to provide the data of a comparative study between Lichtenstein hernioplasties done under local versus spinal anaesthesia as well as add more data in this scenario.Methods: In this non randomized clinical study, 84 patients were selected by calculation of sample size. 42 patients were operated under spinal anaesthesia and another 42 were operated under local anaesthesia.Results: Mean duration of operation was slightly was slightly more in local anaesthesia i.e. 62.5 minutes (SD=17.8) versus 51.1 minutes (SD=21.5) in spinal anaesthesia. At 6 hours, 12 hours and 24 hours postoperative pain was significantly less in local anaesthesia group in comparison to spinal anaesthesia group with p=0.04, p=0.042, p=0.041 respectively. Postoperative complications like urinary retention, hypotension, and headache were more in spinal anaesthesia than in local anaesthesia. Duration of hospital stay was significantly less in local anaesthesia group i.e. 24.5 hours (SD=12.8) in comparison to spinal group 57.1 hours (SD=16.7).Conclusions:The study concludes that in local anaesthesia group, postoperative pain was significantly less and postoperative complications like urinary retention, headache, and hypotension were less evident compared to spinal anaesthesia. Hence the study concludes that local anaesthesia can be used as an alternative of spinal anaesthesia as a standard mode of anaesthesia for Lichtenstein hernioplasty operation.  

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

2020 ◽  
Author(s):  
Manizheh Sayyah-Melli ◽  
Maryam Kazemi-Shishavan ◽  
Nooshin Behravan ◽  
Parvin Mostafa Gharabaghi ◽  
Vahideh Rahmani
Keyword(s):  
Clinical Trial ◽  
Postoperative Complications ◽  
Controlled Trial ◽  
Uterine Wall ◽  
Uterine Bleeding ◽  
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 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

scholarly journals “Effect of Yoga Intervention on Skeletal Muscle Linked Glucose Homeostasis in Pre-Diabetic Individuals: Study Protocol for a Randomized Controlled Trial”

2021 ◽  
Author(s):  
Supriya Sudhakar Bhalerao ◽  
Jayshree Kharche ◽  
Shubhangi Harke
Keyword(s):  
Skeletal Muscle ◽  
Glycemic Control ◽  
Controlled Trial ◽  
Training Session ◽  
Muscle Quality ◽  
Clinical Trial Registry ◽  
Primary Defect ◽  
Skeletal Muscle Function ◽  
Effective Measure ◽  
Randomized Clinical Study

Abstract Background- The pre-diabetic stage is important in terms of identification and timely management, as it is reversible. Along with other factors, insulin resistance in skeletal muscle is often considered as primary defect before development of overt hyperglycemia and diabetes. Proven to have many health benefits, Yoga has emerged as an effective measure in management of diabetes. As the Yogic postures are relatable to exercises, it was considered for improving skeletal muscle function and reverse the pre-diabetic stage.Methods- The present open, randomized clinical study is planned to evaluate the effect of Yoga interventions on muscle mass, strength, endurance and flexibility which are direct or indirect indicators of fat deposition in skeletal muscles. The study will also explore association between changes in muscle quality/ functionality and glycemic control. With Ethics committee permission, 120 pre-diabetic individuals of either sex between the age group of 35-49 years with a BMI in the range of 25-35 kg/m2 and family history of T2DM will be recruited in study after obtaining written informed consent. They will be randomly allocated to either Yoga or exercise group by computer generated randomized method in a 1:1 ratio. One group will receive defined Yoga interventions, while other group will receive fixed program of physical exercises. Both groups will undergo a training session for a period of 4 weeks under the supervision of a trained instructor, before 12-week study duration. The outcome measures will be parameters related to muscle quality/functionality and glucose metabolism markers. Discussion- Our study aims to study usefulness of Yoga in prediabetic stage on skeletal muscle related glycemic control, which is novel. In addition, the study will generate awareness about pre-diabetes and provide people with active coping skills for reversing it. Trial Registration- Clinical Trial Registry-India -CTRI/2019/05/019149, registered on: 15/05/2019

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

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

Use of breathable silicone technology in an ostomy appliance flange

2021 ◽  
Vol 30 (Sup8) ◽  
pp. 25-35
Author(s):  
Peta Lager ◽  
Lisa Loxdale
Keyword(s):  
Preliminary Data ◽  
Transepidermal Water Loss ◽  
User Evaluation ◽  
Skin Damage ◽  
Healthcare Use ◽  
Skin Injury ◽  
Moisture Management ◽  
Peristomal Skin ◽  
Medical Adhesive ◽  
Over Time

Leaks and peristomal skin complications are highly prevalent among people with a stoma, reported by over 80% of ostomates within 2 years of surgery. This suggests that there is room for improvement in ostomy appliances, particularly in their hydrocolloid-based adhesive flanges. Hydrocolloid has an absorptive method of moisture management that, over time, risks maceration and skin stripping, potentially leading to moisture-associated skin damage (MASD) and medical adhesive-related skin injury (MARSI). The newly developed Genii ostomy appliances (Trio Healthcare) use novel Sil2 Breathable Silicone Technology to provide secure, effective adhesion and manage moisture levels by replicating natural transepidermal water loss (TEWL). This has the potential to increase appliance wear time, reduce incidence of MASD and permit atraumatic removal without adhesive remover, reducing the risks of MARSI, as well as time burdens on the user and economic burdens on the healthcare system. Meanwhile, the silicone flanges and water-resistant sports fabric pouches are lightweight, flexible and unobtrusive, and they are the first appliances to be available in colours to match different skin tones, all of which provides security, comfort, confidence and discretion. This article explores the features of Sil2 and Genii ostomy appliances, with reference to preliminary data from a user evaluation.

Activity Tracking After Surgery: Does It Correlate With Postoperative Complications?

2021 ◽  
pp. 000313482098881
Author(s):  
Yehonatan Nevo ◽  
Tali Shaltiel ◽  
Naama Constantini ◽  
Danny Rosin ◽  
Mordechai Gutman ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Enhanced Recovery ◽  
Length Of Hospital Stay ◽  
Inverse Correlation ◽  
Complication Rates ◽  
Activity Tracking ◽  
Primary Endpoints ◽  
Specific Complication ◽  
Secondary Endpoints ◽  
Enhanced Recovery Programs

Background Postoperative ambulation is an important tenet in enhanced recovery programs. We quantitatively assessed the correlation of decreased postoperative ambulation with postoperative complications and delays in gastrointestinal function. Methods Patients undergoing major abdominal surgery were fitted with digital ankle pedometers yielding continuous measurements of their ambulation. Primary endpoints were the overall and system-specific complication rates, with secondary endpoints being the time to first passage of flatus and stool, the length of hospital stay, and the rate of readmission. Results 100 patients were enrolled. We found a significant, independent inverse correlation between the number of steps on the first and second postoperative days (POD1/2) and the incidence of complications as well as the recovery of GI function and the likelihood of readmission ( P < .05). POD2 step count was an independent risk factor for severe complications ( P = .026). Discussion Digitally quantified ambulation data may be a prognostic biomarker for the likelihood of severe postoperative complications.

Roxadustat for anemia in patients with end-stage renal disease incident to dialysis

2021 ◽  
Author(s):  
Robert Provenzano ◽  
Evgeny Shutov ◽  
Liubov Eremeeva ◽  
Svitlana Korneyeva ◽  
Lona Poole ◽  
...  
Keyword(s):  
Rescue Therapy ◽  
Controlled Trial ◽  
Epoetin Alfa ◽  
Open Label ◽  
Treatment Groups ◽  
Intention To Treat ◽  
Primary Endpoints ◽  
Stage Renal Disease ◽  
End Stage ◽  
Event Rates

Abstract Background We evaluated the efficacy and safety of roxadustat vs. epoetin alfa for the treatment of chronic kidney disease (CKD) related anemia in patients new to dialysis. Methods This was a phase 3, open-label, epoetin alfa-controlled trial. Eligible adults were on hemodialysis/peritoneal dialysis for ≥2 weeks and ≤4 months before randomization and had mean hemoglobin ≤10.0 g/dL. Primary endpoints were mean hemoglobin (g/dL) change from baseline averaged over weeks 28–52 regardless of rescue therapy (non-inferiority criterion: lower limit of 95% CI for treatment difference &gt; −0.75) and percentage of patients achieving a hemoglobin response between weeks 1–24 censored for rescue therapy (non-inferiority margin for between-group difference: −15%). Adverse events were monitored. Results The intention-to-treat population included patients randomized to roxadustat (n = 522) or epoetin alfa (n = 521). Mean (SD) hemoglobin changes from baseline averaged over weeks 28–52 were 2.57 (1.27) and 2.36 (1.21) in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior (least-squares mean difference: 0.18 [95% CI: 0.08, 0.29]) to epoetin alfa. Percentages of patients with a hemoglobin response were 88.2% and 84.4% in the roxadustat and epoetin alfa groups. Roxadustat was non-inferior to epoetin alfa (treatment-group difference: 3.5% [95% CI: −0.7%, 7.7%]). Adverse event rates were comparable between treatment groups. Conclusions Roxadustat was efficacious for correcting and maintaining hemoglobin levels compared to epoetin alfa. Roxadustat had an acceptable safety profile.

Using a novel breathable silicone adhesive (Sil2 technology) in stoma appliances to improve peristomal skin health: answering the key questions

2021 ◽  
Vol 30 (Sup8) ◽  
pp. 19-24
Author(s):  
Fiona Le Ber
Keyword(s):  
Skin Damage ◽  
Skin Injury ◽  
Moisture Management ◽  
Silicone Adhesive ◽  
Peristomal Skin ◽  
Medical Adhesive ◽  
Key Questions ◽  
Stoma Care

Fiona Le Ber answers some of the questions that stoma care nurses may have regarding this novel silicone adhesive based technology, which helps to avoid medical adhesive related skin injury (MARSI) and moisture-associated skin damage (MASD). Whereas hydrocolloid stoma appliances absorb moisture, this has a non-absorptive method of moisture management that prevents peristomal skin becoming damp and excoriated.

scholarly journals Lidocaine coinfusion alleviates vascular pain induced by hypertonic saline infusion: a randomized, placebo-controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhiping Song ◽  
Shibiao Chen ◽  
Yang Zhang ◽  
Xiaoyun Shi ◽  
Na Zhao ◽  
...  
Keyword(s):  
Hypertonic Saline ◽  
Saline Solution ◽  
Time Slot ◽  
Controlled Trial ◽  
Saline Infusion ◽  
Clinical Trial Registry ◽  
Hypertonic Saline Solution ◽  
Vas Scores ◽  
Vascular Pain ◽  
Hypertonic Saline Infusion

Abstract Background Hypertonic saline solution has been frequently utilized in clinical practice. However, due to the nonphysiological osmolality, hypertonic saline infusion usually induces local vascular pain. We conducted this study to evaluate the effect of lidocaine coinfusion for alleviating vascular pain induced by hypertonic saline. Methods One hundred and six patients undergoing hypertonic saline volume preloading prior to spinal anesthesia were randomly allocated to two groups of 53 each. Group L received a 1 mg/kg lidocaine bolus followed by infusion of 2 mg/kg/h through the same IV line during hypertonic saline infusion; Group C received a bolus and infusion of normal saline of equivalent volume. Visual analogue scale (VAS) scores of vascular pain were recorded every 4 min. Results The vascular pain severity in Group L was significantly lower than that in Group C for each time slot (P < 0.05). The overall incidence of vascular pain during hypertonic saline infusion in Group L was 48.0%, which was significantly lower than the incidence (79.6%) in Group C (P < 0.05). Conclusion Lidocaine coinfusion could effectively alleviate vascular pain induced by hypertonic saline infusion. Trial registration Chinese Clinical Trial Registry, number: ChiCTR1900023753. Registered on 10 June 2019.

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