Scandinavian Journal of Surgery最新文献

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Challenges to preserve vascular access functioning after surgical correction for arteriovenous access ischemic steal in hemodialysis patients: A single-center study.
IF 2.5 3区 医学
Scandinavian Journal of Surgery Pub Date : 2025-02-26 DOI: 10.1177/14574969251319854
Eeva-Maija Weselius, Maria Söderström, Maarit Venermo
{"title":"Challenges to preserve vascular access functioning after surgical correction for arteriovenous access ischemic steal in hemodialysis patients: A single-center study.","authors":"Eeva-Maija Weselius, Maria Söderström, Maarit Venermo","doi":"10.1177/14574969251319854","DOIUrl":"https://doi.org/10.1177/14574969251319854","url":null,"abstract":"<p><strong>Background and aims: </strong>Arteriovenous access ischemic steal (AVAIS) is a rare complication that causes morbidity and threatens hemodialysis access usability in patients with end-stage kidney disease (ESKD). This study aimed to determine the incidence of AVAIS over a 15-year period and assess the access usability after surgical correction.</p><p><strong>Methods: </strong>Access operations between January 2007 and August 2022 at Helsinki University Hospital were reviewed. Demographics, clinical, duplex, and contrast examinations with brachial artery volume flows, finger pressures, and delays to surgery were evaluated. Symptom relief, complications, access closures/re-interventions, primary, secondary, and functional patencies were assessed. Endpoints were permanent cessation of access use due to complication(s), transplantation, closure, definitive occlusion, or death.</p><p><strong>Results: </strong>Among 2914 access-related operations, the overall incidence of AVAIS was 2.2%. At the first vascular consultation 52% had ulcer(s) or gangrene(s) resulting in 28 direct closures, and 30 corrections as follows: 20 proximalization of arterial inflow (PAI), 6 flow reduction procedures, 2 distal revascularization with interval ligation (DRIL), 1 distal radial artery ligation (DRAL), and 1 venous bypass. The median time from consultation to surgery was 18 days (range: 0-348 days) for direct closures and 43 days (0-170 days) for corrective surgery. The functional patencies after correction were 60% at 1 year and 55% at 2 years; the primary patencies were 45% and 28% and secondary patencies 61% and 57%, respectively. The functional patencies after PAI were 41% and 31%, respectively.</p><p><strong>Conclusion: </strong>In AVAIS, access preservation is challenging in ESKD patients with multiple diseases. Attention should be paid to the original choice of vascular access by considering each patient's risks. Delay to vascular consultation and intervention should be minimized. PAI should be reserved for selected patients when no other option is preferable.</p>","PeriodicalId":49566,"journal":{"name":"Scandinavian Journal of Surgery","volume":" ","pages":"14574969251319854"},"PeriodicalIF":2.5,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143517058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical prediction model for gangrenous appendicitis: A retrospective single-center study.
IF 2.5 3区 医学
Scandinavian Journal of Surgery Pub Date : 2025-02-20 DOI: 10.1177/14574969251319853
Toshiyuki Suzuki, Akiyo Matsumoto, Daisuke Sugiki, Takahiko Akao, Hiroshi Matsumoto
{"title":"Clinical prediction model for gangrenous appendicitis: A retrospective single-center study.","authors":"Toshiyuki Suzuki, Akiyo Matsumoto, Daisuke Sugiki, Takahiko Akao, Hiroshi Matsumoto","doi":"10.1177/14574969251319853","DOIUrl":"https://doi.org/10.1177/14574969251319853","url":null,"abstract":"<p><strong>Background and aims: </strong>Gangrenous appendicitis, a type of complicated appendicitis, is an indication of emergency surgery due to a high risk of perforation. However, it can be challenging to diagnose preoperatively. This study aimed to validate the predictive factors of patients with gangrenous appendicitis and develop a novel scoring model based on objective parameters.</p><p><strong>Methods: </strong>This retrospective single-center study included 171 of 302 consecutive patients undergoing appendectomy between April 2014 and December 2023. Patients with perforation, chronic appendicitis, and appendicitis presenting with an abscess were excluded from the analysis. In other words, the study targeted Grades 1 and 2 on the American Association for the Surgery of Trauma (AAST) severity assessment scale. Computed tomography (CT) scan value was defined as the average value of fluid in the appendix lumen on plain CT scan. Univariate and multivariate analyses were performed to identify the independent objective predictors of gangrenous appendicitis. A new scoring model was developed based on the logistic regression coefficients of the independent predictors. The scores were then classified into three categories, and the probability of gangrenous appendicitis for each category was evaluated.</p><p><strong>Results: </strong>Overall, 46 (27%) and 125 (73%) patients presented with gangrenous appendicitis (=AAST Grade 2) and non-gangrenous (uncomplicated) appendicitis (=AAST Grade 1), respectively. The independent predictive factors of gangrenous appendicitis included a CT value of ≥24 HU, an appendiceal diameter of ≥12 mm, the presence of cecal mucosal edema, and a C-reactive protein level of ≥5.4 mg/dL. The scoring model, based on these four independent predictors, ranged from 0 to 4. The probability values of gangrenous appendicitis were 0%, 15%, and 97% in the low (0)-, moderate (1, 2)-, and high (3, 4)-risk categories, respectively.</p><p><strong>Conclusion: </strong>Our scoring model may assist in decision-making concerning emergency surgery and appendicitis management.</p>","PeriodicalId":49566,"journal":{"name":"Scandinavian Journal of Surgery","volume":" ","pages":"14574969251319853"},"PeriodicalIF":2.5,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143469782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reduced length of stay and less systemic complications, implementation of the optimized DIEP recovery pathway.
IF 2.5 3区 医学
Scandinavian Journal of Surgery Pub Date : 2025-02-19 DOI: 10.1177/14574969241312286
Ina Korpiola, Päivi Merkkola-von Schantz, Elena Surcel, Susanna Kauhanen, Maiju Härmä
{"title":"Reduced length of stay and less systemic complications, implementation of the optimized DIEP recovery pathway.","authors":"Ina Korpiola, Päivi Merkkola-von Schantz, Elena Surcel, Susanna Kauhanen, Maiju Härmä","doi":"10.1177/14574969241312286","DOIUrl":"https://doi.org/10.1177/14574969241312286","url":null,"abstract":"<p><strong>Background and aims: </strong>The present study aimed to compare patients who underwent deep inferior epigastric perforator (DIEP) flap reconstruction with and without the implementation of the new optimized surgical recovery pathway. The new protocol aims to standardize and optimize perioperative management, shorten hospital stays, and lower complication rates for patients undergoing major surgical procedures.</p><p><strong>Methods: </strong>Consecutive patients who underwent immediate or delayed DIEP flap breast reconstruction were included in this study. Data regarding patient demographics, timing, laterality of reconstruction, hospital length of stay (LOS), and drain management were collected and compared for the pre-protocol group and the post-protocol group.</p><p><strong>Results: </strong>The pre-protocol group consisted of 65 patients, while the post-protocol group consisted of 68 patients. The two groups had similar total complication rates (pre-protocol 43.1% versus post-protocol 32.4%, <i>p</i> = 0.20). Between the two groups, there was a significantly lower rate of major surgical complications in the post-protocol group (pre-protocol 32.3% versus post-protocol 14.7%, <i>p</i> = 0.016). There were no significant differences between the groups regarding minor surgical complications (pre-protocol 7.7% versus post-protocol 17.6%, <i>p</i> = 0.086). In the pre-protocol group, the mean LOS was 6.1 days (range = 4-10, median = 6); in the post-protocol group, the mean LOS was 3.6 days (range = 3-10, median = 3; <i>p</i> < 0.00001). Majority of the post-protocol patients were discharged on postoperative day 3 (<i>n</i> = 47, 69.1%).</p><p><strong>Conclusion: </strong>Patients undergoing DIEP flap reconstruction can be discharged earlier without risking their safety by following the new protocol.</p>","PeriodicalId":49566,"journal":{"name":"Scandinavian Journal of Surgery","volume":" ","pages":"14574969241312286"},"PeriodicalIF":2.5,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143450711","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of oncological outcomes of T1-3 N1 rectal cancer patients treated with neoadjuvant radiotherapy versus no radiotherapy: A retrospective cohort study.
IF 2.5 3区 医学
Scandinavian Journal of Surgery Pub Date : 2025-02-13 DOI: 10.1177/14574969251319201
Suvi Marjasuo, Laura Koskenvuo, Anna Lepistö
{"title":"Comparison of oncological outcomes of T1-3 N1 rectal cancer patients treated with neoadjuvant radiotherapy versus no radiotherapy: A retrospective cohort study.","authors":"Suvi Marjasuo, Laura Koskenvuo, Anna Lepistö","doi":"10.1177/14574969251319201","DOIUrl":"https://doi.org/10.1177/14574969251319201","url":null,"abstract":"<p><strong>Background and aims: </strong>Neoadjuvant short-course radiotherapy (SCRT) prior to surgery has been used to reduce local recurrences in moderately advanced rectal cancer (RC). Total mesorectal excision (TME) surgery by itself can reduce the local recurrence rate in these patients. The objective was to assess whether discontinuing neoadjuvant SCRT had a negative impact on survival and local recurrence rates of moderately advanced RC.</p><p><strong>Methods: </strong>This retrospective study examined 137 consecutive patients (67 neoadjuvant SCRT, 70 TME without neoadjuvant therapy) treated for rT1-3N1M0 RC without extramural venous invasion (EMVI) or a threatened surgical margin between January 2016 and March 2020 in a tertiary rectal surgery referral center. The primary objective was the impact of neoadjuvant therapy on overall, cancer-specific, and disease-free survival, and local recurrence rate. Secondary outcomes were risk factors affecting survival. The analyses were conducted on the total study cohort as well as a propensity score matched cohort of the same patient group, with the matching predicated upon age, gender, and histological T score.</p><p><strong>Results: </strong>The oncological outcomes were similar between the two different treatment groups. The 5-year cumulative overall survival rate, calculated using the Kaplan-Meier method, was 89.6% in the neoadjuvant SCRT group and 83.5% in the surgery-only group (<i>p</i> = 0.570), with the corresponding cancer-specific survival rates at 97.0% and 98.4% (<i>p</i> = 0.219) and disease-free survival rates at 97.0% and 91.9% (<i>p</i> = 0.438). No local recurrencies were detected in either group during the 5-year follow-up period.</p><p><strong>Conclusion: </strong>The omission of neoadjuvant SCRT in rT1-3N1M0 RC with no EMVI and no threatened resection margin caused no adverse effects on the survival of the patients. Based on this series, it appears that avoiding SCRT does not compromise the oncological outcome in these patients.</p>","PeriodicalId":49566,"journal":{"name":"Scandinavian Journal of Surgery","volume":" ","pages":"14574969251319201"},"PeriodicalIF":2.5,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143416018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of surgical specialization on long-term survival after emergent colon cancer resections.
IF 2.5 3区 医学
Scandinavian Journal of Surgery Pub Date : 2025-01-23 DOI: 10.1177/14574969241312290
Jenny Engdahl, Astrid Öberg, Sandra Bech-Larsen, Stefan Öberg
{"title":"Impact of surgical specialization on long-term survival after emergent colon cancer resections.","authors":"Jenny Engdahl, Astrid Öberg, Sandra Bech-Larsen, Stefan Öberg","doi":"10.1177/14574969241312290","DOIUrl":"https://doi.org/10.1177/14574969241312290","url":null,"abstract":"<p><strong>Background: </strong>The impact of surgical specialization on long-term survival in patients undergoing emergent colon cancer resections remains unclear.</p><p><strong>Method: </strong>A retrospective analysis was conducted on all patients who underwent emergent colon cancer resections at a secondary care hospital between 2010 and 2020. The most senior surgeon performing the procedures was classified as colorectal surgeon (CS) or non-colorectal surgeon (NCS). NCS was further divided into acute care surgeons (ACSs) or general surgeons (GSs). Overall survival (OS) and cancer-free survival (CFS) were compared in patients operated by surgeons with different specializations.</p><p><strong>Results: </strong>A total of 235 emergent resections were performed during the study period, of which 99 (42%) were performed by CS and 136 (58%) by NCS. In adjusted Cox regression analyses, OS and CFS were similar in patients operated on by CS and NCS (hazard ratio (HR) for OS: 1.02 (0.72-1.496), <i>p</i> = 0.899 and HR for CFS: 0.91 (0.61-1.397), <i>p</i> = 0.660). Similarly, OS and CFS were equivalent in patients operated by ACS and CS (HR for OS: 1.10 (0.75-1.62), <i>p</i> = 0.629 and HR for CFS: 1.24 (0.80-1.92), <i>p</i> = 0.343). However, patients operated by GS had significantly shorter OS and CFS (HR for OS: 1.78 (1.05-3.00), <i>p</i> = 0.031 and HR for CFS: 1.83 (1.02-3.26), <i>p</i> = 0.041) compared with those operated by ACS and CS.</p><p><strong>Conclusion: </strong>Long-term survival after emergent colon cancer resections was similar in patients operated on by CS and NCS, and the subgroup of ACS, indicating equivalent comparable surgical quality. The less favorable poorer survival observed for patients operated on by GS may possibly be due to less frequent exposure to colorectal and emergent surgery.</p>","PeriodicalId":49566,"journal":{"name":"Scandinavian Journal of Surgery","volume":" ","pages":"14574969241312290"},"PeriodicalIF":2.5,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143025438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparison of reconstruction techniques after pancreatoduodenectomy: A single-center retrospective cohort study. 胰十二指肠切除术后重建技术的比较:单中心回顾性队列研究。
IF 2.5 3区 医学
Scandinavian Journal of Surgery Pub Date : 2025-01-10 DOI: 10.1177/14574969241312287
Iago Justo Alonso, Paola Peralta Fernández-Revuelta, Alberto Marcacuzco Quinto, Oscar Caso Maestro, Laura Alonso Murillo, Carlos Jiménez-Romero
{"title":"Comparison of reconstruction techniques after pancreatoduodenectomy: A single-center retrospective cohort study.","authors":"Iago Justo Alonso, Paola Peralta Fernández-Revuelta, Alberto Marcacuzco Quinto, Oscar Caso Maestro, Laura Alonso Murillo, Carlos Jiménez-Romero","doi":"10.1177/14574969241312287","DOIUrl":"https://doi.org/10.1177/14574969241312287","url":null,"abstract":"<p><strong>Background: </strong>There is controversy regarding which is the best reconstruction technique after the pancreatoduodenectomy. Currently, there are no studies comparing the three most frequent reconstruction techniques: Whipple + Roux-en-Y gastrojejunostomy (WRYGJ), pyloric-preserving + Billroth II (PPBII), and Whipple + BII (WBII).</p><p><strong>Methods: </strong>Between 2012 and March 2023, 246 patients underwent pancreaticoduodenectomy with the following type of reconstruction techniques: (1) WRYGJ: 40 patients; (2) PPBII: 118 patients; and (3) WBII: 88 patients. A retrospective comparative study among these groups was performed.</p><p><strong>Results: </strong>No significant differences were found among the groups regarding duration of the surgery, the blood volume transfused, or caliber of the Wirsung duct. The size and types of tumors, the degree of differentiation and tumor invasion of the peripancreatic tissue, vascular and neural structures, and lymph nodes were similar among the groups. The rate of R0 resection was lower in WBII (62.5% [55/88]) than in WRYGJ (75% [30/40]) and PPBII (72% [85/118]), but statistically insignificant among the groups (p = 0.232). The incidences of relevant B/C postoperative pancreatic fistula (POPF) were similar among the groups: 7.5% (7/40) in WRYGJ, 17% (20/118) in PPBI, and 26.2% (23/88) in WBII (p = 0.292). In addition, the incidence of B/C delayed gastric emptying (DGE) was higher in WBII (27.3% [24/88]) than in WRYGJ (20% [8/40]) and PPBII (19.5% [23/118]) but statistically insignificance among the groups (p = 0.381). The incidence of medical and surgical complications, intensive care unit and hospital stays, morbimortality at 90 days, and 5-year survival were similar among the groups. Multivariate analysis revealed that POPF grade B/C was a risk factor for DGE grade B/C (odds ratio (OR) = 9.903, 95% confidence interval (CI) = 4.829-20.310; p < 0.001), and a <3-mm Wirsung duct was a risk factor for POPF (OR = 3.604, 95% CI = 1.791-7.254; p < 0.001).</p><p><strong>Conclusion: </strong>No technique was superior to the others. Only relevant POPF B/C was a risk factor for DGE B/C, and <3 mm Wirsung for a POPF.</p>","PeriodicalId":49566,"journal":{"name":"Scandinavian Journal of Surgery","volume":" ","pages":"14574969241312287"},"PeriodicalIF":2.5,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Stent stoma: Endoscopic stent insertion for refractory small intestine fistulas. 支架造瘘:内镜下支架置入治疗难治性小肠瘘。
IF 2.5 3区 医学
Scandinavian Journal of Surgery Pub Date : 2025-01-10 DOI: 10.1177/14574969241310051
Marcus Kantowski, Peter Sauer, Michael Ardelt, Nathaniel Melling, Thomas Roesch, Chengcheng Christine Zhang
{"title":"Stent stoma: Endoscopic stent insertion for refractory small intestine fistulas.","authors":"Marcus Kantowski, Peter Sauer, Michael Ardelt, Nathaniel Melling, Thomas Roesch, Chengcheng Christine Zhang","doi":"10.1177/14574969241310051","DOIUrl":"https://doi.org/10.1177/14574969241310051","url":null,"abstract":"<p><strong>Background and aims: </strong>The therapeutic management of fistulas presents significant challenges, often involving both conservative and surgical approaches. Despite these interventions, recurrence and postoperative mortality rates remain high. Endoscopic stent insertion into the fistula, along with the creation of a stent stoma, may offer a promising alternative for patients who fail surgical or conservative therapies. This study aimed to evaluate the feasibility, effectiveness, and safety of endoscopic stent insertion in the treatment of refractory small intestinal fistulas.</p><p><strong>Methods: </strong>Patients with refractory small intestine fistulas who underwent endoscopic stent insertion were included. The primary endpoint was defined as successful fistula treatment, which included an improvement in clinical symptoms related to the fistula, successful bridging to subsequent surgical revision, and the restoration of enteral nutrition. Secondary endpoints comprised the feasibility of the endoscopic procedure, complications, procedure-related complications, and in-hospital mortality.</p><p><strong>Results: </strong>Eight patients were included, with a median follow-up period of 2.7 months. The implantation of a self-expanding metal stent was successfully performed in all patients (technical success rate, 100%; <i>n</i> = 8/8). The clinical success rate was 87.5% (<i>n</i> = 7/8), indicating clinical improvement in fistula-related symptoms, wound care, and enteral nutrition. Procedure-related complications occurred in one patient (12.5%; <i>n</i> = 1/8), involving stent dislocation leading to small intestine perforation, which was managed endoscopically. No procedure-related mortality was observed.</p><p><strong>Conclusions: </strong>Endoscopic stent insertion is a feasible, effective, and safe option for the management of therapy-refractory small intestinal fistulas. The creation of a stent stoma improves patient quality of life.</p>","PeriodicalId":49566,"journal":{"name":"Scandinavian Journal of Surgery","volume":" ","pages":"14574969241310051"},"PeriodicalIF":2.5,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142957824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Letter to the Editor: Emergency surgery influences oncological outcome in small intestinal neuroendocrine tumors. 致编辑的信:急诊手术影响小肠神经内分泌肿瘤的预后。
IF 2.5 3区 医学
Scandinavian Journal of Surgery Pub Date : 2024-12-22 DOI: 10.1177/14574969241310047
Waleed Ahmad, Abdur Rehman
{"title":"Letter to the Editor: Emergency surgery influences oncological outcome in small intestinal neuroendocrine tumors.","authors":"Waleed Ahmad, Abdur Rehman","doi":"10.1177/14574969241310047","DOIUrl":"https://doi.org/10.1177/14574969241310047","url":null,"abstract":"","PeriodicalId":49566,"journal":{"name":"Scandinavian Journal of Surgery","volume":" ","pages":"14574969241310047"},"PeriodicalIF":2.5,"publicationDate":"2024-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142878442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A randomized double-blind noninferiority clinical multicenter trial on oral moxifloxacin versus placebo in the outpatient treatment of uncomplicated acute appendicitis: APPAC IV study protocol. 口服莫西沙星与安慰剂在门诊治疗无并发症急性阑尾炎的随机双盲非劣效性临床多中心试验:APPAC IV研究方案。
IF 2.5 3区 医学
Scandinavian Journal of Surgery Pub Date : 2024-12-05 DOI: 10.1177/14574969241293018
Heidi Lund, Jussi Haijanen, Saku Suominen, Saija Hurme, Suvi Sippola, Tuomo Rantanen, Tero Rautio, Anne Mattila, Tarja Pinta, Pia Nordström, Jyrki Kössi, Imre Ilves, Paulina Salminen
{"title":"A randomized double-blind noninferiority clinical multicenter trial on oral moxifloxacin versus placebo in the outpatient treatment of uncomplicated acute appendicitis: APPAC IV study protocol.","authors":"Heidi Lund, Jussi Haijanen, Saku Suominen, Saija Hurme, Suvi Sippola, Tuomo Rantanen, Tero Rautio, Anne Mattila, Tarja Pinta, Pia Nordström, Jyrki Kössi, Imre Ilves, Paulina Salminen","doi":"10.1177/14574969241293018","DOIUrl":"https://doi.org/10.1177/14574969241293018","url":null,"abstract":"<p><strong>Background: </strong>Antibiotic therapy is currently considered a safe and effective treatment alternative for computed tomography (CT)-confirmed uncomplicated acute appendicitis with recent studies reporting good results on both oral antibiotics only and outpatient management. Furthermore, there are promising pilot results on uncomplicated acute appendicitis management with symptomatic treatment (placebo). This trial aims to assess whether both antibiotics and hospitalization can be safely omitted from the treatment of uncomplicated acute appendicitis.</p><p><strong>Methods: </strong>The APPAC IV (APPendicitis Acuta IV) trial is a randomized, double-blind, multicenter noninferiority clinical trial comparing oral moxifloxacin with oral placebo in an outpatient setting with a discharge directly from the emergency room (ER). Adult patients (18-60 years) with CT-confirmed uncomplicated acute appendicitis (absence of appendicolith, abscess, perforation, tumor, appendiceal diameter ⩾15 mm on CT, or body temperature >38 °C) will be enrolled in nine Finnish hospitals. Primary outcome is treatment success at 30 days, that is, the resolution of acute appendicitis resulting in discharge from the hospital without appendectomy during the 30-day follow-up evaluated using a noninferiority design with a noninferiority margin of 6 percentage points. Noninferiority will be evaluated using one-sided 95% confidence interval of proportion difference between groups. Secondary endpoints include postintervention complications, recurrent appendicitis after the 30-day follow-up, duration of hospital stay, admission to hospital and reason for admission, readmissions to emergency department or hospitalization, VAS pain scores, quality of life, sick leave, and treatment costs. The follow-up after discharge from the ER includes a phone call at day 1, and at 3-4 days, 30 days, and 1, 3, 5, 10, and 20 years. Those eligible patients, who decline to undergo randomization, will be invited to participate in a concurrent observational cohort study with follow-up at 30 days, and 1 and 5 years.</p><p><strong>Discussion: </strong>To our knowledge, APPAC IV trial is the first large randomized, double-blind, noninferiority multicenter clinical trial aiming to compare oral antibiotics and placebo for CT-diagnosed uncomplicated acute appendicitis in an outpatient setting. The study aims to bridge the major knowledge gap on whether antibiotics and hospitalization or both can be omitted in the treatment of uncomplicated acute appendicitis.</p><p><strong>Trial registration: </strong>The study protocol has been approved by the Clinical Trials Information System (CTIS) of the European Medicines Agency (EMA), study number: 2023-506213-21-00 and the trial has been registered in ClinicalTrials.gov, NCT06210269.</p>","PeriodicalId":49566,"journal":{"name":"Scandinavian Journal of Surgery","volume":" ","pages":"14574969241293018"},"PeriodicalIF":2.5,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786564","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Modern surgical treatments for lymphedema. 淋巴水肿的现代外科治疗。
IF 2.5 3区 医学
Scandinavian Journal of Surgery Pub Date : 2024-12-04 DOI: 10.1177/14574969241300101
Marie Kearns, Susanna Kauhanen, Maria Mani
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