International Journal of Surgery Protocols最新文献

Introduction: Ageing of the general population has led to an increase in the use of suboptimal kidneys from expanded criteria donation after brain death (ECD-DBD) and donation after circulatory death (DCD) donors. However, these kidneys have inferior graft outcomes and lower rates of immediate function. Normothermic machine perfusion (NMP) may improve outcomes of these suboptimal donor kidneys. Previous non-randomized studies have shown the safety of this technique and suggested its efficacy in improving the proportion of immediate functioning kidneys compared to static cold storage (SCS). However, its additional value to hypothermic machine perfusion (HMP), which has already been proved superior to SCS, has not yet been established.

Methods and analysis: This single-center, open-label, randomized controlled trial aims to assess immediate kidney function after 120 minutes additional, end-ischemic NMP compared to HMP alone. Immediate kidney function is defined as no dialysis treatment in the first week after transplant. Eighty recipients on dialysis at the time of transplant who receive an ECD-DBD or DCD kidney graft are eligible for inclusion. In the NMP group, the donor kidney is taken of HMP upon arrival in the recipient hospital and thereafter put on NMP for 120 minutes at 37 degrees Celsius followed by transplantation. In the control group, donor kidneys stay on HMP until transplantation. The primary outcome is immediate kidney function.

Ethics and dissemination: The protocol has been approved by the Medical Ethical Committee of Erasmus Medical Center (2020-0366). Results of this study will be submitted to peer-reviewed journals.

Registration: registered in clinicaltrials.gov (NCT04882254).

Highlights: This is the first RCT to compare additional NMP to HMP alone.Extensive sampling will offer in-depth analysis of kidney physiology during NMP.This RCT may help identify biomarkers to predict clinical outcomes during NMP.Biomarkers can help develop NMP as assessment tool for declined kidneys.

Background: Various sites are used for specimen extraction in oncological minimally invasive colorectal surgery. The objective is to determine if the choice of extraction site modulates the incidence of incisional hernia (IH).

Methods/design: A systematic review will be performed in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. MEDLINE, Embase and CENTRAL will be searched to look for original studies reporting the incidence of IH after minimally invasive colorectal surgery. Studies will be excluded from the analysis if: 1) they do not report original data, 2) the outcome of interest (incidence of incisional hernia) is not clearly reported and does not allow to extrapolate and/or calculate the required data for network meta-analysis, 3) they include pediatric patients, 4) they include a patients' population with a conversion rate to laparotomy >10%, 5) they do not compare at least two different extraction sites for the operative specimen, 6) they report patients who underwent pure (and not hybrid) natural orifice transluminal endoscopic surgery (NOTES). Network meta-analysis will be performed to determine the incidence of IH per extraction site.

Discussion: By determining which specimen extraction site leads to reduced rate of IH, this systematic review and network meta-analysis will help colorectal surgeons to choose their extraction site and reduce the morbidity and costs associated with IH.

Registration: The systematic review and meta-analysis protocol is registered in the International Prospective Register of Ongoing Systematic Reviews (PROSPERO) with number CRD42021272226.

Highlights: Various sites are used for specimen extraction in oncological minimally invasive colorectal surgery, and the choice of the site may probably modulate the incidence of incisional hernia.The present protocol aims to design a systematic review which will identify original studies comparing two extraction sites during minimally invasive colorectal surgery in terms of incidence of incisional hernia.Network meta-analysis will be performed to determine the incidence of IH per extraction site.

Introduction: Percutaneous thermal ablation is widely adopted as a curative treatment approach for unresectable liver neoplasms. Accurate immediate assessment of therapeutic response post-ablation is critical to achieve favourable outcomes. The conventional technique of side-by-side comparison of pre- and post-ablation scans is challenging and hence there is a need for improved methods, which will accurately evaluate the immediate post-therapeutic response.

Objectives and significance: This review summarizes the findings of studies investigating the feasibility and efficacy of the fusion imaging systems in the immediate post-operative assessment of the therapeutic response to thermal ablation in liver neoplasms. The findings could potentially empower the clinicians with updated knowledge of the state-of-the-art in the assessment of treatment response for unresectable liver neoplasms.

Methods and analysis: A rapid review will be performed on publicly available major electronic databases to identify articles reporting the feasibility and efficacy of the fusion imaging systems in the immediate assessment of the therapeutic response to thermal ablation in liver neoplasms. The risk of bias and quality of articles will be assessed using the Cochrane risk of bias tool 2.0 and Newcastle Ottawa tool.

Ethics and dissemination: Being a review, we do not anticipate the need for any approval from the Institutional Review Board. The outcomes of this study will be published in a peer-reviewed journal.

Highlights: Evaluation of the therapeutic response in liver neoplasms immediately post-ablation is critical to achieve favourable patient outcomes. We will examine the feasibility and technical efficacy of different fusion imaging systems in assessing the immediate treatment response post-ablation. The findings are expected to guide the clinicians with updated knowledge on the state-of-the-art when assessing the immediate treatment response for unresectable liver neoplasms.

Diverticular disease is an increasingly common issue, with a variety of clinical presentations and treatment options. However, very few prospective cohort studies explore outcomes between the different presentations and treatments. The Diverticular Disease Registry (DDR Trial) is a multicenter, prospective, observational cohort study on behalf of the Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network. The DDR Trial aims to investigate the short-term postoperative and long-term quality of life outcomes in patients undergoing surgery or medical treatments for diverticular disease. DDR Trial is open to participation by all tertiary-care hospitals. DDR Trial has been registered at ClinicalTrials.gov (NCT04907383). Data collection will be recorded on Research Electronic Data Capture (REDCap) starting on June 1^st, 2021 and will end after 5 years of recruitment. All adult patients with imaging-proven colonic diverticular disease (i.e., symptomatic colonic diverticulosis including diverticular bleeding, diverticulitis, and Symptomatic Uncomplicated Diverticular Disease) will be included. The primary outcome of DDR Trial is quality of life assessment at 12-month according to the Gastrointestinal Quality of Life Index (GIQLI). The secondary outcome is 30-day postoperative outcomes according to the Clavien-Dindo classification. DDR Trial will significantly advance in identifying the optimal care for patients with diverticular disease by exploring outcomes of different presentations and treatments.

Highlights: Diverticular disease (i.e., diverticulitis, bleeding) has different treatments.This is a clinical protocol for the Diverticular Disease Registry (DDR Trial).DDR Trial is a multicenter, prospective, observational cohort study open to participation.DDR Trial will study short-term postoperative and long-term quality of life outcomes.Medical treatments, interventional radiology and surgery will be explored.

Introduction: Although single-incision laparoscopic appendectomy (SILA) was introduced decades ago, it is still considered a difficult technique to perform compared to conventional laparoscopic appendectomy (CLA). In addition, controversy about the benefits of SILA compared to CLA abound and no definite criteria for choosing SILA over CLA in patients with appendicitis currently exist. Therefore, we have planned a multi-center randomized controlled trial to compare SILA with CLA in terms of cosmetic satisfaction and pain reduction.

Methods and analysis: Patients diagnosed with appendicitis at the participating centers will be recruited and allocated into either a CLA or an SILA groups using a 1:1 randomization. Patients in the CLA group will receive a conventional 3-port laparoscopic appendectomy and patients in the SILA group will receive a laparoscopic appendectomy using a single-incision at the umbilicus. The primary trial endpoint is cosmetic satisfaction assessed using the Patients and Observer Scar Assessment Scale (POSAS) administered 6 weeks post-surgery. Secondary trial endpoints include cosmetic satisfaction assessed via the Body Image Questionnaire, pain levels assessed via the Visual Analog Scale and International Pain Outcomes questionnaire, and the presence of postoperative complications. The target sample size of this superiority trial is 120 patients, as this will provide 80% power at the 2.5% level of significance to detect a 3-point difference in POSAS.

Discussion: The results of this planned multi-center randomized controlled trial will provide substantive evidence to help surgeons choose when to use SILA over CLA in patients with appendicitis.

Ethics and dissemination: This trial was approved by the institutional review board at Daegu joint on February 27, 2020 (No: 19-12-001-001) and registered with the clinical research information service (CRIS) (KCT0005048). The results of the study will be published and presented at appropriate conferences.

Highlights: To investigate the clinical benefits comparing between single incision laparoscopic appendectomy and conventional laparoscopic appendectomyTo assess the pain and cosmetic satisfaction through quantitative scales, Patient-Reported Outcomes Measures (PROMs), International Pain Outcome (IPO) Questionnaire, the Patient and Observer Scar Assessment Scale (POSAS), and the Body Image Questionnaire (BIQ)To help surgeons choose when to use single incision laparoscopic appendectomy in patients with appendicitis.

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.