International Journal of Surgery Protocols最新文献

Some genetic factors may influence body composition, such as PPARγ and UCP2. PPARγ plays an important role in body fat distribution. The objective of the present study is to determine the effects of omega3 fatty acids on the gene expression of PPARγ and UCP2, levels of blood lipid profile, fat mass, and fat-free mass, and appetite. Elite male athlete volunteers of up to 36 subjects were invited to participate in this RCT. Following a public announcement, volunteers were recruited from gyms, teams, and sports medicine boards in Tabriz, Iran. Gene's expression of PPARγ and UCP2, serum levels of blood lipid profile, fat mass, and fat-free mass was collected. Data collection time points include baseline in addition to 3 weeks follow up. The study was approved by the Ethics Committee of the Tabriz University Medical of Sciences (IR.TBZMED.REC.1398.782) in October 2019 and was registered with the Iranian Registry of Clinical Trials: 20190625044008N1 on December 19, 2019. Recruitment began in July and concluded in December 2019. As of August 19, 2019, we have screened 373 volunteers. 36 were enrolled. Baseline measurements of participants were collected. After three-week of intervention, end study measurements of participants were collected. The results are expected to be released in 2021. Participants have a median age of 21.86 (±3.15). The finding of this study showed Results showed PPARγ mRNA levels, and UCP2 mRNA and protein levels increased in the omega3 group (p < 0.05), as did REE (p < 0.05). Also, differences in the sensation of hunger or satiety were significant (p < 0.05). This study could result in the effects of omega-3 fatty acids on PPARγ, and UCP2 expressions, blood lipid profiles and body composition. In addition, the results of this trial can be used as baseline information for conducting further clinical and sport nutrition studies.

Trial registration: The trial was registered at the Iranian registry of the clinical trial website (www.irct.ir) as IRCT20190625044008N1 (https://en.irct.ir/trial/43332), registered at (19/12/2019).

Highlights: Omega3 fatty acids as a ligand of metabolic-related genes, have a role in energy expenditure.Omega3 supplements effect on PPARγ and UCP2 mRNA expression as regulators of energy metabolismOmega3 supplements increased REE.Omega-3 supplementation could change the changes in body composition.For athletes, omega-3 simultaneously decreased fat mass and increased fat-mass.HDL-C increased after short-term supplementation with omega-3.Increased intake of omega-3, caused increased intake of energy and protein.

Background: Exposure to inhaled allergens in patients with allergic rhinitis results in IgE mediated hypersensitivity of nasal mucosa. The mainstay of management is allergen identification and avoidance, pharmacotherapy with antihistamines, corticosteroids and nasal douching and immunotherapy. Patients refractory to medical management can be offered surgical interventions aimed at providing symptom relief. The objective of this review is to evaluate the effectiveness of surgical intervention on functional and symptomatic outcomes in patients with allergic rhinitis that have failed medical management.

Methods: Prospective and retrospective studies that assess the effectiveness of intranasal surgery to include inferior turbinate surgery, posterior nerve resection, vidian neurectomy, septoplasty and endoscopic sinus surgery (ESS) in patients that have failed medical treatment for proven allergic rhinitis. Medline, Web of Science and Embase will be searched for studies published in English from 1990. Two authors will independently screen the search results and assess the full text of potentially relevant studies. Studies that meet the inclusion criteria will be critically appraised and the data will be extracted and synthesised by two authors.

Ethics and dissemination: Ethical approval was not required for this study as secondary data will be collected. The results will be disseminated through peer-reviewed medical journal.

Systematic review registration: This protocol has been registered on the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42020223773).

Highlights: Allergic rhinitis (AR) is a chronic immune-mediated inflammatory nasal condition with hallmark symptoms of sneezing, nasal obstruction, mucus discharge and anosmia in adverse cases.A plethora of interventions are at the hands of otolaryngologists in order to relieve symptoms of AR, however literature is yet to determine which method is best for patient outcome and quality of life.The primary objective of this study is to convey a systematic qualitative analysis of all the surgical interventions used in AR management.

Background: Esophageal atresia (EA) is a congenital malformation affecting 1:3000-4500 newborns. Approximately 15% have a long-gap EA (LGEA), in which case a primary anastomosis is often impossible to achieve. To create continuity of the esophagus patients instead have to undergo lengthening procedures or organ interpositions; methods associated with high morbidity and poor functional outcomes. Esophageal injections of Botulinum Toxin Type A (BTX-A) could enable primary anastomosis and mitigate stricture formation through decreased tissue tension.

Methods and analysis: In this randomized controlled blinded animal trial, 24 pigs are divided into a long- or short-gap EA group (LGEA and SGEA, respectively) and randomized to receive BTX-A or isotonic saline injections. In the LGEA group, injections are given endoscopically in the esophageal musculature. After seven days, a 3 cm esophageal resection and primary anastomosis is performed. In the SGEA group, a 1 cm esophageal resection and primary anastomosis is performed, followed by intraoperative injections of BTX-A or isotonic saline. After 14 days, stricture formation, presence of leakage, and esophageal compliance is assessed using endoscopic and manometric techniques, and in vivo and ex vivo contrast radiography. Tissue elongation is evaluated in a stretch-tension test, and the esophagus is assessed histologically to evaluate anastomotic healing.

Ethics and dissemination: The study complies with the ARRIVE guidelines for animal studies and has been approved by the Danish Animal Experimentation Council. Results will be published in peer-reviewed journals and presented at national and international conferences.

Highlights: The optimal management of long-gap esophageal atresia remains controversialPrimary anastomosis could improve functional outcomes and reduce complicationsBotulinum Toxin Type A decreases tissue tension and could facilitate anastomosisReduced tension could further abate the risk for anastomotic stricture and leakageWe present a model to evaluate the method in long- and short-gap esophageal atresia.

Introduction: Postoperative ileus (poi) is defined as a temporary cessation of bowel movement after a surgical procedure. Cessation of bowel movement not only leads to disturbing constipation but also may lead to nausea, loss of appetite, and food intolerance. Literature reports "sham feeding" (gum-chewing) effect as an increase in chewing and saliva which enhances the gastric emptying and overall motility of gut as a cephalic phase of digestion. Therefore, we aim to assess the effect of adding gum-chewing to the conventional postoperative feeding regimen on restoring postoperative bowel function and length of stay in hospital of patients undergoing elective hip arthroplasty.

Methods and analysis: This is a single-center, open-label, parallel design, superiority randomized-controlled trial with 2 treatment arms. The primary and secondary outcomes will be the time interval in hours from the end of surgery until the passage of flatus and the time interval in hours from the end of surgery until the passage of stool. Statistical analysis will be done using STATA software. Length of stay will be calculated by Kaplan-Meier analysis, with unadjusted comparison of groups by Mantel-Cox log rank test. Risk ratios for the time-to-become ileus free and time-to-discharge from hospital will be calculated by Cox regression modeling. P value as 0.05 or less will be taken as significant.

Ethics and dissemination: This protocol is exempted from Ethical review at this stage however all the required approvals will be taken from the ethical review committee before starting the study. Informed consent will be taken form the patient to enroll him/her in the study. Results of the study will be disseminated to the study participants, public health, and clinical professionals. The results would also be published in a reputable international journal.

Trial registration: This trial is registered on clinicaltrials.gov with ID: NCT04489875.

Highlights: Cessation of bowel movement not only leads to disturbing constipation but also may lead to nausea, loss of appetite, and food intolerance.These patients tend to have more pain scores and dissatisfaction with the surgical management and team.The "sham feeding" (gum-chewing) effect causes an increase in chewing and saliva formation and therefore enhances the gastric emptying and overall motility of gut as a cephalic phase of digestion even in non-gastro or colorectal surgeries.We hypothesize that there is an association between gum chewing and the relief from postoperative ileus in hip arthroplasty patients.

Introduction: Perioperative complications, especially intraoperative adverse events (iAEs), carry significant potential for long-term sequelae in a patient's postoperative course. These events represent a substantial gap in contemporary surgical literature, with only a fraction of publications reporting intraoperative complications as outcomes of interest. To date, there is no universal standard for comprehensively reporting intraoperative complications in surgical practice and literature beyond the systems developed for grading individual events. We aim to establish a set of best-practice criteria for iAE reporting known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) Guidelines.

Methods and analysis: We will generate the ICARUS reporting guidelines using the EQUATOR Network development framework and the SQUIRE Guidelines. The initial step involves an umbrella review and meta-analysis of systemic reviews (SRs) assessing the perioperative adverse events of common surgeries. Measures for assessing, collecting, grading, and reporting the iAEs will be merged into a comprehensive list of criteria. Using a modified Delphi methodology, a team of expert surgeons (≥ 200 inpatient procedures/years) will contribute to and evaluate the proposed reporting guidelines. The panel will evaluate both the clinical usefulness and quality assessment and improvement utility of each criterion using a 5-point Likert. We expect multiple survey rounds until consensus regarding the utility of the guidelines is reached.

Dissemination: We plan to share then validate the newly developed guidelines within each surgical field. Dissemination will involve publicly shared guidelines, simultaneous journal publications, conference presentations, encouragement for journal endorsement, and application for inclusion in the Equator Network database. The study team plans to continue collecting feedback for future extension of the intraoperative reporting guidelines.

Highlights: Intraoperative adverse events are underreported and lack homogeneity in surgical literatureWe aim to use a modified Delphi methodology to develop the consensus-based, intraoperative complications assessment and reporting with universal standards (ICARUS) guidelinesWe will disseminate the ICARUS guidelines through journal publications and presentations at national and international meetings; journals and professional organizations will be encouraged to endorse the ICARUS guidelines.

Introduction: Knee arthroplasty also known as the total knee replacement is an orthopedic surgical procedure done to resurface the knee that has been severely damaged by arthritis. After the completion of the surgical procedure, the skin closure is done. The optimal goal of skin closure after the procedure is to promote rapid healing and an acceptable cosmetic result while minimizing the risk of infection. Skin closure after knee arthroplasty is done by using either of the two widely used sutures i.e., polypropylene (Prolene) sutures or the skin staple sutures. There are no standard guidelines as which type of the suture should be used. The present study aims to compare the incidence of surgical site infections (superficial and deep) for Prolene vs staple sutures in the bilateral knee arthroplasty patients within 6 weeks for superficial and within 90 days for deep infection.

Methods: This study will be conducted as an open blinded, parallel design, equivalence randomized controlled trial. The patients would be selected and randomized in 1:1 ratio to receive either of the two interventions i.e., Prolene or Staples. Patients undergoing unilateral or staged total knee replacement (TKR) were excluded.

Analysis: The normality assessment will be done using Shapiro Wilk test. Cox proportional hazard regression will be used to check the univariate and multi-variable associations of independent variables with the outcome. Both intention to treat analysis and per protocol analysis would be performed.

Ethics and dissemination: All the required approvals will be taken from the ethical review committee. Informed consent will be taken form the patient to enroll him/her in the study. Results of the study will be disseminated to the study participants, public health and clinical professionals and would also be published in a reputable international journal.The trial is registered at clinicaltrials.gov and UIN of the registry is NCT04492852.

Highlights: Post-operative surgical site infections and complications are a major concern nowadays.Skin staples are not widely used as compared to Prolene because they are expensive and not easily available in every hospital.There are no standard guidelines as which type of the suture should be used.The type of sutures is being selected on the orders and wishes of the surgeon at the time of skin closure.

Introduction: Surgical treatment of rotator cuff tears commonly entails reattachment of the ruptured tendon to its bony insertion using suture anchors. Suture anchor design has evolved from solid metal anchors to vented biocomposite anchors with potentially biologic consequences. Few studies have investigated the differences between different modern anchor design and materials, making it difficult to justify their use or cost.

Objective: To compare the rate of bony ingrowth and implant resorption between a coil-type open-architecture biocomposite suture anchor and a vented screw-type biocomposite suture anchor, used for arthroscopic double-row rotator cuff repair.

Methods and analysis: In this retrospective comparative study, a consecutive series of patients who undergo a double row rotator cuff repair using a coil-type open architecture biocomposite suture anchor in the medial row and a vented screw-type biocomposite suture anchor in the lateral row will be included. A sample size calculation demonstrated that 16 participants are required in each group. Primary outcome measures will be bony ingrowth and reabsorption of the suture anchor as measured on computed tomography (CT). Secondary outcomes will include patient reported outcome measures (The American Shoulder and Elbow Surgeons score and The Western Ontario Rotator Cuff questionnaire), range of motion, postoperative tendon integrity, and cyst formation.

Highlights: Open-architecture suture anchors facilitate the release of marrow constituents.The rate of bony ingrowth for coil- and screw-type anchors will be assessed.The difference in functional outcome between the two anchors will be assessed.

Introduction: Postoperative biliary complications in living donor liver transplantation are often difficult to treat, and if treatment is not successful, the patient's QOL is significantly reduced. The frequency of postoperative biliary complications is reported to be higher than that of deceased donor transplantation. In 2013, Lin et al. reported that while biliary reconstruction has traditionally used a surgical surgical loupe (2.5x-4.5x), biliary reconstruction using a surgical microscope (5x-15x) can reduce the incidence of complications. The objective of this study is to clarify the efficacy of biliary reconstruction using surgical microscope in living donor liver transplantation by a multi-facility, randomized comparative study.

Methods and analysis: It is an open-label randomized controlled study in which target patients who meet the registration requirements are randomly allocated to a surgical loupe group and a microscopy group after obtaining their consent (Ratio 1:1). The primary endpoint is an incidence of biliary complications (bile leakage and anastomotic biliary stricture) with Clavien-Dindo class III or higher within 52 weeks following surgery. The secondary endpoint is length of time required for biliary reconstruction using a surgical microscope.

Ethics and dissemination: This study protocol was approved by the institutional review board of Nagasaki University Hospital (No. 20122102-2). The study is registered in UMIN-CTR as UMIN000042011. Written informed consent will be obtained from all participants. The results will be published in a peer-reviewed journal and will be presented at medical meetings.

Highlights: Postoperative biliary complications in living donor liver transplantation are often difficult to treat.Lower incidence of biliary complication following biliary reconstruction using a surgical microscope has been reported.Facilities those use a surgical microscope for biliary reconstruction are limited.The first study to investigate the efficacy of surgical microscope for biliary construction in liver transplantation by randomized controlled trial.

Hydatidosis (Echinococcosis) is a disease caused by infestation of hydatid cysts in any organ of body but mainly liver (70% of cases). Hydatidosis of salivary glands is rare and necessitate computerized tomography for diagnosis while fine needle aspiration remains controversial procedure.

Materials and methods: 6 patients diagnosed with hydatid cysts of parotid glands. These cases were admitted and treated at the maxillofacial surgery Clinic of the "AL-Ramadi" Hospital in Iraq. 5 patients were female and 1 male with age group was between 30-50 years. The patients complained of painless unilateral swelling in parotid region and who were diagnosed hydatid cysts using CT. All cases were treated by superficial parotidectomy with cystectomy and preservation of facial nerve.

Results: All hydatid cysts are CE1- type with no recurrences were reported in any of these cases. The postoperative edema was the most common complication. Other complications were not seen.

Conclusion: parotid hydatid cyst should be included in differential diagnosis of persistent parotid swelling especially those with history of hepatic hydatid cysts. Computerized tomography is the gold imaging that aid in diagnosis and classification of hydatid cysts. Most cases are CE1 type and Eosinophilia is a sign of concern in some patients. Surgical treatment remains the "gold standard" in therapy.

Highlights: Hydatidosis of parotid glands is rare but must be included in differential diagnosis of cystic swelling of salivary glands especially those with history of hepatic hydatid cysts.The hydatid cysts are classified according to morphology on imaging into 5 typesTotal serum bilirubin, eosinophilia and leukocytosis are seenSuperficial parotidectomy with removal of hydatid cysts is the treatment of choice in parotid hydatid cysts.

Background: Oro-motor intervention methods were previously adopted to improve the sucking pattern but there is still a lag in the structured protocol for improving sucking behavior in infants with immature sucking. Thus, this study is aimed to develop a structured protocol for the Oro-motor intervention to improve sucking behavior.

Method: Using the prospective observational study design, neonates with poor suck (producing less than 10 sucks per minute), under NG tube feeding, and maintaining oxygen saturation at room air were included. A total of 6 subjects were enrolled in this study and they were treated with Oro-motor intervention protocol. The Sucking rate and LATCH score were taken as the outcome measures and measured at beginning of intervention and after 2 weeks of intervention.

Result: The mean pre-test and post-test values for sucking rate were is (8.66), (32.5) and LATCH were (4.66), (8.16) respectively. The data collected showed that the protocol framed for Oro-motor intervention was significantly effective in improving quality of feeding among infants with immature sucking behavior.

Conclusion: The structured Oro-motor intervention protocol improves the feeding performance in infants with poor sucking behavior and improves the LATCH score. All the infants included in this study where under nasogastric tube feeding, thus the structured protocol can be considered to be helpful in weaning from NG tube feeding.