O05 1-YEAR RESULTS OF AN INTERNATIONAL RANDOMIZED CONTROLLED TRIAL (ESTOIH STUDY) COMPARING THE “SHORT STITCH” VERSUS “LONG STITCH” TECHNIQUE USING AN ULTRA-LONG ABSORBABLE ELASTIC SUTURE MATERIAL

Abstract Aim The aim of this multicenter, randomized, double blinded study was to compare the short stitch technique for elective, primary, median laparotomy closure with the long stitch closure using the ultra-long absorbable, elastic monofilament suture made of poly 4-hydroxybutyrate (MonoMax®). Material and Methods Eligible patients were randomly allocated to receive either the short or the long stitch suture technique in a 1:1 ratio in 9 centers in Austria and Germany after elective midline laparotomy. Results 425 patients were randomized to receive either the short stitch (n = 215) or long stitch technique (n = 210). In a cox proportional hazards model, the risk for burst abdomen was reduced by 7-fold (HR 0.183 (0.0427 - 0.7435), p = 0.0179) for the short stitch group. Complications such as seroma, hematoma and other wound healing disorders occurred without significant differences between groups. After one year, the incisional hernia rate was 3.65% in the short stitch group compared to 8.80% in the long stitch group (p = 0.055). The combination of burst abdomen and incisional hernia rate had a significantly lower rate of 5.38% for the short stitch technique compared to 13.17% for the long stitch technique (p = 0.0142). Conclusions Both in the short-term results, the short-stitch technique showed substantial advantages in burst abdomen rate, as well as in the 1-year follow-up regarding the incidence of incisional hernias. The low incidence of incisional hernia in the short stitch technique with MonoMax® is promising in comparison to previously published data and should be confirmed in the 3-year follow-up.

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Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽

10.1177/17085381211010022 ◽

2021 ◽

pp. 170853812110100

Author(s):

Mohamed Shukri Abdelgawad ◽

Amr M El-Shafei ◽

Hesham A Sharaf El-Din ◽

Ehab M Saad ◽

Tamer A Khafagy ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Radiofrequency Ablation ◽

Controlled Trial ◽

Compression Therapy ◽

Randomized Controlled ◽

Venous Ulcers ◽

Group A ◽

Group B ◽

To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

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Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression

Scientific Reports ◽

10.1038/s41598-021-87198-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Mona Dietrichkeit ◽

Marion Hagemann-Goebel ◽

Yvonne Nestoriuc ◽

Steffen Moritz ◽

Lena Jelinek

Keyword(s):

Side Effects ◽

Side Effect ◽

Statistical Power ◽

Controlled Trial ◽

Treatment Options ◽

Cognitive Remediation ◽

Negative Effects ◽

Metacognitive Training ◽

To Receive

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.

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A randomized controlled study to compare the efficacy of hughes abdominal repair with conventional abdominal closure-to reduce the incidence of incisional hernias in Indian population

International Surgery Journal ◽

10.18203/2349-2902.isj20172783 ◽

2017 ◽

Vol 4 (7) ◽

pp. 2291

Author(s):

Rajasekaran C. ◽

Vijaykumar K. ◽

Arulkumaran M. ◽

Meera S. S.

Keyword(s):

Randomized Controlled Trial ◽

Incisional Hernia ◽

Abdominal Wall ◽

Controlled Trial ◽

Secondary Outcome ◽

Midline Laparotomy ◽

Incisional Hernias ◽

Abdominal Closure ◽

Randomized Controlled ◽

Abdominal Repair

Background: Incisional hernia forms the most common delayed morbidity following midline laparotomy surgeries- causing mental trauma to the patient impairing their quality of life and scars the name and fame of the surgeon. So, the need for possible attributes on surgeon’s aspect to prevent the incisional hernia is the need of the hour. We planned a randomized controlled trial to compare two different abdominal closure techniques to reduce the incidence of Incisional hernia following midline laparotomy incisions. We advocated Hughes abdominal repair which includes a series of two horizontal and two vertical mattresses within single suture whereby the tension load of suture is distributed both along and across the suture line.Methods: 1:1 Randomized controlled trial in which the patient is blinded and obviously operating surgeon is non-blinded. Evaluating examiner and radiologist are blinded.100 patients who underwent emergency and elective midline laparotomies were enrolled in the study and intra-operatively randomized into two groups in 1:1 pattern. Ethical clearance obtained from the Institutional ethical committee. The primary outcome measure is the incidence of burst abdomen at the end of 15 days by the evaluating surgeon (non-operated surgeon who is blinded). The secondary outcome is the incidence of incisional hernia at the end of one year-evaluated by detailed clinical examination with radiological proof using CT abdomen.Results: The incidence of incisional hernia is significantly low in Hughes abdominal repair than conventional abdominal closure.Conclusions: Hughes abdominal wall closure is superior to conventional closure in both emergency and elective laparotomy cases, in prevention of wound dehiscence and Incisional hernias later. Present study encourages us that Hughes abdominal wall repair is comparable to mesh repairs. This study needs to be continued further to a vast sample size to perfectly assess the statistical significance.

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PREEMER trial: Study protocol for a randomized controlled trial

10.21203/rs.3.rs-18884/v1 ◽

2020 ◽

Author(s):

Elisa Mäkäräinen-Uhlbäck ◽

Matti Tolonen ◽

Ville Sallinen ◽

Panu Mentula ◽

Ari Leppäniemi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Incisional Hernia ◽

Controlled Trial ◽

Control Group ◽

Emergency Setting ◽

University Hospitals ◽

Comprehensive Complication Index ◽

Midline Laparotomy ◽

Randomized Controlled ◽

Hernia Prevention

Abstract Background: Despite the fact that, in itself, emergency midline laparotomy is a factor risk for an incisional hernia, active research on hernia prevention in emergency settings is lacking. Different kinds of meshes and mesh positions have been studied in elective abdominal surgery, but no randomized controlled trials in emergency settings have been published.Methods: The PREEMER trial is a multicenter, double-blinded, randomized controlled trial to be conducted in seven hospitals in Finland (Oulu, Helsinki, Tampere, and Turku university hospitals and Jyväskylä, Lahti, and Seinäjoki non-university hospitals). A total of 244 patients will be randomized at a 1:1 ratio to either the retrorectus mesh group, featuring a self-gripping prophylactic mesh, or to the no mesh (control) group, both closed by small stitch 4:1 closure with continuous slowly absorbable monofilament suturing. The primary outcome of the PREEMER trial is the incisional hernia incidence two years after surgery, which will be detected clinically and/or radiologically. Secondary outcomes are the Comprehensive Complication Index score, incidence of surgical site infections and fascial dehiscence within 30 days of surgery; the incisional hernia repair rate and mesh- or hernia-related re-operations within the two- and five-year follow-ups; the incidence of incisional hernia within the five-year follow-up; and quality of life measured by RAND-36, the Activities Assessment Scale (AAS), and the PROMIS-questionnaire within 30 days and two and five years from surgery. Additionally, medico-economic explorative measures are analyzed.Discussion: The PREEMER Trial will provide level 1 evidence on incisional hernia prevention in an emergency setting.Trial registration: Clinical Trials NCT04311788https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009MXF&selectaction=Edit&uid=U0003YIA&ts=2&cx=7ef75k. Registered March 7th, 2020

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Digital versus Analog Procedures for the Prosthetic Restoration of Single Implants: A Randomized Controlled Trial with 1 Year of Follow-Up

BioMed Research International ◽

10.1155/2018/5325032 ◽

2018 ◽

Vol 2018 ◽

pp. 1-20 ◽

Cited By ~ 16

Author(s):

Francesco Mangano ◽

Giovanni Veronesi

Keyword(s):

Treatment Time ◽

Controlled Trial ◽

Marginal Bone Loss ◽

Digital Workflow ◽

Digital Impressions ◽

Monolithic Zirconia ◽

Ceramic Crown ◽

To Receive ◽

Single Implant

Aim. To compare the outcome of digital versus analog procedures for the restoration of single implants. Methods. Over a two-year period (2014-2016), all patients who had been treated in a dental center with a single implant were randomly assigned to receive either a monolithic zirconia crown, fabricated with digital workflow (test group), or a metal-ceramic crown, fabricated with analog workflow (control group). All patients were followed for 1 year after the delivery of the final crown. The outcomes were success, complications, peri-implant marginal bone loss (PIMBL), patient satisfaction, and time and cost of the treatment. Results. 50 patients (22 males, 28 females; mean age 52.6±13.4 years) were randomly assigned to one of the groups (25 per group). Both workflows showed high success (92%) and low complication rate (8%). No significant differences were found in the mean PIMBL between test (0.39±0.29mm) and control (0.54±0.32mm) groups. Patients preferred digital impressions. Taking the impression took half the time in the test group (20±5min) than in the control (50±7min) group. When calculating active working time, workflow in the test group was more time-efficient than in the control group, for provisional (70±15min versus 340±37min) and final crowns (29±9min versus 260±26min). The digital procedure presented lower costs than the analog (€277.3 versus €392.2). Conclusions. No significant clinical or radiographic differences were found between digital and analog procedures; however, the digital workflow was preferred by patients; it reduced active treatment time and costs. The present study is registered in the ISRCTN (http://www.isrctn.com/ISRCTN36259164) with number 36259164.

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Manganese and Lipoflavonoid Plus® to Treat Tinnitus: A Randomized Controlled Trial

Journal of the American Academy of Audiology ◽

10.3766/jaaa.15106 ◽

2016 ◽

Vol 27 (08) ◽

pp. 661-668 ◽

Cited By ~ 2

Author(s):

Eveling Rojas-Roncancio ◽

Richard Tyler ◽

Hyung-Jin Jun ◽

Tang-Chuan Wang ◽

Haihong Ji ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Data Collection And Analysis ◽

Loudness Match ◽

Minimal Masking Level ◽

Lost To Follow Up ◽

To Receive

Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus. Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus® to treat their tinnitus. Research Design: Randomized controlled trial. Study Sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus® for 6 months, or Lipoflavonoid Plus® only (as the control). Data Collection and Analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level. Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement. Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus® is an effective treatment for tinnitus.

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DHA supplementation in infants born preterm and the effect on attention at 18 months’ corrected age: follow-up of a subset of the N3RO randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114520002500 ◽

2020 ◽

pp. 1-12 ◽

Cited By ~ 2

Author(s):

Erandi Hewawasam ◽

Carmel T. Collins ◽

Beverly S. Muhlhausler ◽

Lisa N. Yelland ◽

Lisa G. Smithers ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

High Dose ◽

Peak Period ◽

Soya Oil ◽

Randomised Controlled ◽

To Receive ◽

The Brain

Abstract Infants born preterm miss out on the peak period of in utero DHA accretion to the brain during the last trimester of pregnancy which is hypothesised to contribute to the increased prevalence of neurodevelopmental deficits in this population. This study aimed to determine whether DHA supplementation in infants born preterm improves attention at 18 months’ corrected age. This is a follow-up of a subset of infants who participated in the N3RO randomised controlled trial. Infants were randomised to receive an enteral emulsion of high-dose DHA (60 mg/kg per d) or no DHA (soya oil – control) from within the first days of birth until 36 weeks’ post-menstrual age. The assessment of attention involved three tasks requiring the child to maintain attention on toy/s in either the presence or absence of competition or a distractor. The primary outcome was the child’s latency of distractibility when attention was focused on a toy. The primary outcome was available for seventy-three of the 120 infants that were eligible to participate. There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0·08 s, 95 % CI –0·81, 0·97; P = 0·86). Enteral DHA supplementation did not result in improved attention in infants born preterm at 18 months’ corrected age.

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Leucocyte-Rich Platelet-Rich Plasma Treatment of Gluteus Medius and Minimus Tendinopathy: A Double-Blind Randomized Controlled Trial With 2-Year Follow-up

The American Journal of Sports Medicine ◽

10.1177/0363546519826969 ◽

2019 ◽

Vol 47 (5) ◽

pp. 1130-1137 ◽

Cited By ~ 17

Author(s):

Jane Fitzpatrick ◽

Max K. Bulsara ◽

John O’Donnell ◽

Ming Hao Zheng

Keyword(s):

Randomized Controlled Trial ◽

Ultrasound Guidance ◽

Platelet Rich Plasma ◽

Corticosteroid Injection ◽

Controlled Trial ◽

Harris Hip Score ◽

Randomized Controlled ◽

Gluteal Tendinopathy ◽

To Receive

Background: A previously published trial showed that patients with chronic gluteal tendinopathy achieved greater clinical improvement at 12 weeks when treated with a single platelet-rich plasma (PRP) injection than those treated with a single corticosteroid injection (CSI). Purpose: This follow-up study was conducted to determine whether there would be a sustained long-term difference in the modified Harris Hip Score (mHHS) at 2 years for a leucocyte-rich PRP (LR-PRP) injection in the treatment of chronic gluteal tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This trial included 80 patients randomized 1:1 to receive LR-PRP or CSI intratendinously under ultrasound guidance. Patients had a mean age of 60 years, a 9:1 ratio of women to men, a mean body mass index of 27, and a mean length of symptoms >15 months. No patients had full-thickness tears of the gluteal tendons. An open-labeled extension allowed patients to receive crossover treatment after 3 months. The main outcome measure was the mHHS. Results: The mean mHHS improved significantly at 12 weeks in the PRP group (74.05; SD, 13.92) as compared with the CSI group (67.13; SD, 16.04) ( P = .048). At 24 weeks, the LR-PRP group (77.60; SD, 11.88) improved further than the CSI group (65.72; SD, 15.28; P = .0003). Twenty-seven patients were deemed to have failed the CSI treatment at 16 to 24 weeks, with an exit score of 59.22 (SD, 11.54), and then had treatment with LR-PRP. The crossover group improved with the LR-PRP: from 59.22 (SD, 11.22) at baseline to 75.55 (SD, 16.05) at 12 weeks, 77.69 (SD, 15.30) at 24 weeks, and 77.53 (SD, 14.54) at 104 weeks. The LR-PRP group retained 38 of 39 patients to 52 weeks and continued to improve. Their baseline scores of 53.77 (SD, 12.08) improved to 82.59 (SD, 9.71) at 104 weeks ( P < .0001). Conclusion: Among patients with chronic gluteal tendinopathy and a length of symptoms >15 months, a single intratendinous LR-PRP injection performed under ultrasound guidance results in greater improvement in pain and function than a single CSI. The improvement after LR-PRP injection is sustained at 2 years, whereas the improvement from a CSI is maximal at 6 weeks and not maintained beyond 24 weeks. Registration: ACTRN12613000677707 (Australian New Zealand Clinical Trials identifier).

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Long-term Follow-up of a Randomized Controlled Trial of Suture Versus Mesh Repair of Incisional Hernia

Transactions of the Meeting of the American Surgical Association ◽

10.1097/01.sla.0000141193.08524.e7 ◽

2004 ◽

Vol CXXII (&NA;) ◽

pp. 176-183 ◽

Cited By ~ 83

Author(s):

Jacobus W.A. Burger ◽

Roland W. Luijendijk ◽

Wim C.J. Hop ◽

Jens A. Halm ◽

Emiel G.G. Verdaasdonk ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Incisional Hernia ◽

Mesh Repair ◽

Controlled Trial ◽

Randomized Controlled ◽

Long Term Follow Up

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EMDR Individual Protocol for Paraprofessional Use: A Randomized Controlled Trial With First Responders

Journal of EMDR Practice and Research ◽

10.1891/1933-3196.7.2.55 ◽

2013 ◽

Vol 7 (2) ◽

pp. 55-64 ◽

Cited By ~ 16

Author(s):

Ignacio Jarero ◽

Carolina Amaya ◽

Martha Givaudan ◽

Alaide Miranda

Keyword(s):

Controlled Trial ◽

First Responders ◽

Global Improvement ◽

Randomized Controlled ◽

Posttraumatic Symptoms ◽

Significant Difference ◽

To Receive ◽

Nonsignificant Decrease ◽

Supportive Counseling

The eye movement desensitization and reprocessing (EMDR) individual protocol for paraprofessional use in acute trauma situations (EMDR-PROPARA) is part of a project developed at the initiative of Dr. Francine Shapiro. This randomized clinical trial examined the effectiveness of the protocol administered by experienced EMDR therapists. There were 39 traumatized first responders on active duty randomly assigned to receive two 90-min sessions of either EMDR-PROPARA or of supportive counseling. Participants in the EMDR-PROPARA group showed benefits immediately after treatment, with their scores on the Short PTSD Rating Interview (SPRINT) showing further decreases at 3-month follow-up. In comparison, supportive counseling participants experienced a nonsignificant decrease after treatment and an increase in the SPRINT scores at the second follow-up. The significant difference between the two treatments provides preliminary support for EMDR-PROPARA’s effectiveness in reducing severity of posttraumatic symptoms and subjective global improvement. More controlled research is recommended to evaluate further the efficacy of this intervention.

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