| 1. |
- Lagergren, Jesper, et al.
(författare)
-
Extent of lymphadenectomy and prognosis after esophageal cancer surgery
- 2015
-
Ingår i: JAMA Surgery. - Stockholm : Karolinska Institutet, Dept of Molecular Medicine and Surgery. - 2168-6254 .- 2168-6262.
-
Tidskriftsartikel (refereegranskat)abstract
- Importance: The prognostic role of the extent of lymphadenectomy during surgery for esophageal cancer is uncertain and requires clarification. Objective: To clarify whether the number of removed lymph nodes influences mortality following surgery for esophageal cancer. Design, Setting, and Participants: Conducted from January 1, 2000, to January 31, 2014, this was a cohort study of patients who underwent esophagectomy for cancer in 2000-2012 at a high-volume hospital for esophageal cancer surgery, with follow-up until 2014. Exposures: The main exposure was the number of resected lymph nodes. Secondary exposures were the number of metastatic lymph nodes and positive to negative lymph node ratio. Main Outcomes and Measures: The independent role of the extent of lymphadenectomy in relation to all-cause and disease-specific 5-year mortality was analyzed using Cox proportional hazard regression models, providing hazard ratios (HRs) with 95% CIs. The HRs were adjusted for age, pathological T category, tumor differentiation, margin status, calendar period of surgery, and response to preoperative chemotherapy. Results: Among 606 included patients, 506 (83.5%) had adenocarcinoma of the esophagus, 323 (53%) died within 5 years of surgery, and 235 (39%) died of tumor recurrence. The extent of lymphadenectomy was not statistically significantly associated with all-cause or disease-specific mortality, independent of the categorization of lymphadenectomy or stratification for T category, calendar period, or chemotherapy. Patients in the fourth quartile of the number of removed nodes (21-52 nodes) did not demonstrate a statistically significant reduction in all-cause 5-year mortality compared with those in the lowest quartile (0-10 nodes) (HR, 0.86; 95% CI, 0.63-1.17), particularly not in the most recent calendar period (HR, 0.98; 95% CI, 0.57-1.66 for years 2007-2012). A greater number of metastatic nodes and a higher positive to negative node ratio was associated with increased mortality rates, and these associations showed dose-response associations. Conclusions and Relevance: This study indicated that the extent of lymphadenectomy during surgery for esophageal cancer might not influence 5-year all-cause or disease-specific survival. These results challenge current clinical guidelines. This cohort study indicates that the extent of lymphadenectomy during surgery for esophageal cancer might not influence the 5-year all-cause or disease-specific survival. These results challenge current clinical guidelines.
|
|
| 2. |
- Analatos, Apostolos, et al.
(författare)
-
Clinical Outcomes of a Laparoscopic Total vs a 270 degrees Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease : A Randomized Clinical Trial
- 2022
-
Ingår i: JAMA Surgery. - : American Medical Association (AMA). - 2168-6254 .- 2168-6262. ; 157:6, s. 473-480
-
Tidskriftsartikel (refereegranskat)abstract
- Importance The efficacy of fundoplication operations in the management of gastroesophageal reflux disease (GERD) has been documented. However, few prospective, controlled series report long-term (>10 years) efficacy and postfundoplication concerns, particularly when comparing various types of fundoplication.Objective To compare long-term (>15 years) results regarding mechanical complications, reflux control, and quality of life between patients undergoing posterior partial fundoplication (PF) or total fundoplication (TF) (270 degrees vs 360 degrees) in surgical treatment for GERD.Design, setting and participants A double-blind randomized clinical trial was performed at a single center (Ersta Hospital, Stockholm, Sweden) from November 19, 2001, to January 24, 2006. A total of 456 patients were recruited and randomized. Data for this analysis were collected from August 1, 2019, to January 31, 2021.Interventions Laparoscopic 270 degrees posterior PF vs 360 degrees TF.Main Outcomes and Measures The main outcome was dysphagia scores for solid and liquid food items after more than 15 years. Generic (36-Item Short-Form Health Survey) and disease-specific (Gastrointestinal Symptom Rating Scale) quality of life and proton pump inhibitor consumption were also assessed.Results Among 407 available patients, relevant data were obtained from 310 (response rate, 76%; mean [SD] age, 66 [11.2] years; 184 [59%] men). A total of 159 were allocated to a PF and 151 to a TF. The mean (SD) follow-up time was 16 (1.3) years. At 15 years after surgery, mean (SD) dysphagia scores were low for both liquids (PF, 1.2 [0.5]; TF, 1.2 [0.5]; P = .58) and solids (PF, 1.3 [0.6]; TF, 1.3 [0.5]; P = .97), without statistically significant differences between the groups. Reflux symptoms were equally well controlled by the 2 types of fundoplications as were the improvements of quality-of-life scores.Conclusions and Relevance The long-term findings of this randomized clinical trial indicate that PF and TF are equally effective for controlling GERD and quality of life in the long term. Although PF was superior in the first years after surgery in terms of less dysphagia recorded, this difference did not prevail when assessed a decade later.
|
|
| 3. |
|
|
| 4. |
- Analatos, Apostolos, et al.
(författare)
-
Hiatal Hernia Repair With Tension-Free Mesh or Crural Sutures Alone in Antireflux Surgery A 13-Year Follow-Up of a Randomized Clinical Trial
- 2024
-
Ingår i: JAMA Surgery. - : American Medical Association (AMA). - 2168-6254 .- 2168-6262. ; 159:1, s. 11-18
-
Tidskriftsartikel (refereegranskat)abstract
- Importance Antireflux surgery is an effective treatment of gastroesophageal reflux disease (GERD), but the durability of concomitant hiatal hernia repair remains challenging. Previous research reported that the use of a mesh-reinforced, tension-free technique was associated with more dysphagia for solid foods after 3 years without reducing hiatal hernia recurrence rates compared with crural sutures alone, but the long-term effects of this technique have not been assessed.Objective To assess the long-term anatomical and functional outcomes of using a mesh for hiatal hernia repair in patients with GERD.Design, Setting, and Participants A double-blind, randomized clinical trial was performed at a single center (Ersta Hospital, Stockholm, Sweden) from January 11, 2006, to December 1, 2010. A total of 159 patients were recruited and randomly assigned. Data for the current analysis were collected from September 1, 2021, to March 31, 2022. All analyses were conducted with the intention-to-treat population.Interventions Closure of the diaphragmatic hiatus with crural sutures alone vs a tension-free technique using a nonabsorbable polytetrafluoroethylene mesh (Bard CruraSoft).Main Outcomes and Measures The primary outcome was radiologically verified recurrent hiatal hernia after more than 10 years. Secondary outcomes were dysphagia scores (ranging from 1 to 4, with 1 indicating no episodes of dysphagia and 4 indicating more than 3 episodes of dysphagia per day) for solid and liquid foods, generic 36-Item Short Form Health Survey and disease-specific Gastrointestinal Symptom Rating Scale symptom assessment scores, proton pump inhibitor consumption, and reoperation rates. Intergroup comparisons of parametric data were performed using t tests; for nonparametric data, Mann-Whitney U, chi(2), or Fisher exact tests were used. For intragroup comparisons vs the baseline at follow-up times, the Friedman test was used, and post hoc analysis was performed using Wilcoxon matched pairs.Results Of 145 available patients, follow-up data were obtained from 103 (response rate 71%; mean [SD] age at follow-up, 65 [11.3] years; 55 [53%] female), with 53 initially randomly assigned to mesh reinforcement, and 50 to crural suture alone. The mean (SD) follow-up time was 13 (1.1) years. The verified radiologic hiatal hernia recurrence rates were 11 of 29 (38%) in the mesh group vs 11 of 35 (31%) in the suture group (P = .61). However, 13 years postoperatively, mean (SD) dysphagia scores for solids remained significantly higher in the mesh group (mean [SD], 1.9 [0.7] vs 1.6 [0.9]; P = .01).Conclusions and Relevance Findings from this long-term follow-up of a randomized clinical trial suggest that tension-free crural repair with nonabsorbable mesh does not reduce the incidence of hiatal hernia recurrence 13 years postoperatively. This finding combined with maintained higher dysphagia scores does not support the routine use of tension-free polytetrafluoroethylene mesh closure in laparoscopic hiatal hernia repair for treatment of GERD.Trial Registration ClinicalTrials.gov Identifier: NCT05069493
|
|
| 5. |
- Azhar, Najia, et al.
(författare)
-
Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: Long-term Outcomes From the Scandinavian Diverticulitis (SCANDIV) Randomized Clinical Trial
- 2021
-
Ingår i: JAMA Surgery. - Chicago, IL, United States : American Medical Association. - 2168-6254 .- 2168-6262. ; 156:2, s. 121-127
-
Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE Perforated colonic diverticulitis usually requires surgical resection, with significant morbidity. Short-term results from randomized clinical trials have indicated that laparoscopic lavage is a feasible alternative to resection. However, it appears that no long-term results are available.OBJECTIVE To compare long-term (5-year) outcomes of laparoscopic peritoneal lavage and primary resection as treatments of perforated purulent diverticulitis.DESIGN, SETTING, AND PARTICIPANTS This international multicenter randomized clinical trial was conducted in 21 hospitals in Sweden and Norway, which enrolled patients between February 2010 and June 2014. Long-term follow-upwas conducted between March 2018 and November 2019. Patients with symptoms of left-sided acute perforated diverticulitis, indicating urgent surgical need and computed tomography-verified free air, were eligible. Those available for trial intervention (Hinchey stagesINTERVENTIONS Patients were assigned to undergo laparoscopic peritoneal lavage or colon resection based on computer-generated, center-stratified block randomization.MAIN OUTCOMES AND MEASURES The primary outcome was severe complications within 5 years. Secondary outcomes included mortality, secondary operations, recurrences, stomas, functional outcomes, and quality of life.RESULTS Of 199 randomized patients, 101were assigned to undergo laparoscopic peritoneal lavage and 98were assigned to colon resection. At the time of surgery, perforated purulent diverticulitiswas confirmed in 145 patients randomized to lavage (n = 74) and resection (n = 71). The median follow-upwas 59 (interquartile range, 51-78; full range, 0-110) months, and 3 patientswere lost to follow-up, leaving a final analysis of 73 patients who had had laparoscopic lavage (mean [SD] age, 66.4 [13] years; 39 men [53%]) and 69 who had received a resection (mean [SD] age, 63.5 [14] years; 36 men [52%]). Severe complications occurred in 36%(n = 26) in the laparoscopic lavage group and 35%(n = 24) in the resection group (P = .92). Overall mortalitywas 32%(n = 23) in the laparoscopic lavage group and 25%(n = 17) in the resection group (P = .36). The stoma prevalencewas 8%(n = 4) in the laparoscopic lavage group vs 33% (n = 17; P =.002) in the resection group among patients who remained alive, and secondary operations, including stoma reversal, were performed in 36%(n = 26) vs 35%(n = 24; P = .92), respectively. Recurrence of diverticulitiswas higher following laparoscopic lavage (21% [n = 15] vs 4%[n = 3]; P = .004). In the laparoscopic lavage group, 30%(n = 21) underwent a sigmoid resection. Therewere no significant differences in the EuroQoL-5Dquestionnaire or Cleveland Global Quality of Life scores between the groups.CONCLUSIONS AND RELEVANCE Long-term follow-up showed no differences in severe complications. Recurrence of diverticulitis after laparoscopic lavage was more common, often leading to sigmoid resection. This must be weighed against the lower stoma prevalence in this group. Shared decision-making considering both short-term and long-term consequences is encouraged.
|
|
| 6. |
- Bagge, Roger Olofsson, et al.
(författare)
-
Population-Based Validation of the MIA and MSKCC Tools for Predicting Sentinel Lymph Node Status
- 2024
-
Ingår i: JAMA Surgery. - : AMER MEDICAL ASSOC. - 2168-6254 .- 2168-6262.
-
Tidskriftsartikel (refereegranskat)abstract
- Importance Patients with melanoma are selected for sentinel lymph node biopsy (SLNB) based on their risk of a positive SLN. To improve selection, the Memorial Sloan Kettering Cancer Center (MSKCC) and Melanoma Institute Australia (MIA) developed predictive models, but the utility of these models remains to be tested.Objective To determine the clinical utility of the MIA and MSKCC models.Design, Setting, and Participants This was a population-based comparative effectiveness research study including 10 089 consecutive patients with cutaneous melanoma undergoing SLNB from the Swedish Melanoma Registry from January 2007 to December 2021. Data were analyzed from May to August 2023.Main Outcomes and Measures, The predicted probability of SLN positivity was calculated using the MSKCC model and a limited MIA model (using mitotic rate as absent/present instead of count/mm(2) and excluding the optional variable lymphovascular invasion) for each patient. The operating characteristics of the models were assessed and compared. The clinical utility of each model was assessed using decision curve analysis and compared with a strategy of performing SLNB on all patients.Results Among 10 089 included patients, the median (IQR) age was 64.0 (52.0-73.0) years, and 5340 (52.9%) were male. The median Breslow thickness was 1.8 mm, and 1802 patients (17.9%) had a positive SLN. Both models were well calibrated across the full range of predicted probabilities and had similar external area under the receiver operating characteristic curves (AUC; MSKCC: 70.8%; 95% CI, 69.5-72.1 and limited MIA: 69.7%; 95% CI, 68.4-71.1). At a risk threshold of 5%, decision curve analysis indicated no added net benefit for either model compared to performing SLNB for all patients. At risk thresholds of 10% or higher, both models added net benefit compared to SLNB for all patients. The greatest benefit was observed in patients with T2 melanomas using a threshold of 10%; in that setting, the use of the nomograms led to a net reduction of 8 avoidable SLNBs per 100 patients for the MSKCC nomogram and 7 per 100 patients for the limited MIA nomogram compared to a strategy of SLNB for all.Conclusions and Relevance This study confirmed the statistical performance of both the MSKCC and limited MIA models in a large, nationally representative data set. However, decision curve analysis demonstrated that using the models only improved selection for SLNB compared to biopsy in all patients when a risk threshold of at least 7% was used, with the greatest benefit seen for T2 melanomas at a threshold of 10%. Care should be taken when using these nomograms to guide selection for SLNB at the lowest thresholds.
|
|
| 7. |
|
|
| 8. |
- Beard, Jessica H., et al.
(författare)
-
Outcomes After Inguinal Hernia Repair With Mesh Performed by Medical Doctors and Surgeons in Ghana
- 2019
-
Ingår i: JAMA Surgery. - : AMER MEDICAL ASSOC. - 2168-6254 .- 2168-6262. ; 154:9, s. 853-859
-
Tidskriftsartikel (refereegranskat)abstract
- Key PointsQuestionWhat are the outcomes after mesh inguinal hernia repair performed by medical doctors compared with surgeons in Ghana? FindingsIn this cohort study of 242 men with primary reducible inguinal hernia, there was no significant difference in hernia recurrence at 1 year after inguinal hernia repair with mesh performed by medical doctors compared with surgeons (0.9% vs 2.8%). MeaningThis study shows that medical doctors can be trained to perform inguinal hernia repair with mesh in men with good results in a low-resource setting and appears to support surgical task sharing to combat the global burden of hernia disease. ImportanceInguinal hernia is the most common general surgical condition in the world. Although task sharing of surgical care with nonsurgeons represents one method to increase access to essential surgery, the safety and outcomes of this strategy are not well described for hernia repair. ObjectiveTo compare outcomes after inguinal hernia repair with mesh performed by medical doctors and surgeons in Ghana. Design, Setting, and ParticipantsThis prospective cohort study was conducted from February 15, 2017, to September 17, 2018, at the Volta Regional Hospital in Ho, Ghana. Following successful completion of a training course, 3 medical doctors and 2 surgeons performed inguinal hernia repair with mesh according to the Lichtenstein technique on 242 men with primary, reducible inguinal hernia. Main Outcomes and MeasuresThe primary end point was hernia recurrence at 1 year. The noninferiority limit was set at 5 percentage points. Secondary end points included postoperative complications at 2 weeks and patient satisfaction, pain, and self-assessed health status at 1 year. ResultsTwo-hundred forty-two patients were included; 119 men underwent operations performed by medical doctors and 123 men underwent operations performed by surgeons. Preoperative patient characteristics were similar in both groups. Two-hundred thirty-seven patients (97.9%) were seen at follow-up at 2 weeks, and 223 patients (92.1%) were seen at follow-up at 1 year. The absolute difference in recurrence rate between the medical doctor group (1 [0.9%]) and the surgeon group (3 [2.8%]) was -1.9 (1-tailed 95% CI, -4.8; Pamp;lt;.001), demonstrating noninferiority of the medical doctors. There were no statistically significant differences in postoperative complications (34 [29.1%] vs 29 [24.2%]), patient satisfaction (112 [98.2%] vs 108 [99.1%]), severe chronic pain (1 [0.9%] vs 4 [3.7%]), or self-assessed health (85.9 vs 83.7 of 100) for medical doctors and surgeons. Conclusions and RelevanceThis study shows that medical doctors can be trained to perform elective inguinal hernia repair with mesh in men with good results and high patient satisfaction in a low-resource setting. This finding supports surgical task sharing to combat the global burden of hernia disease. This cohort study compares the outcomes associated with inguinal hernia repair performed by medical doctors vs surgeons in Ghana.
|
|
| 9. |
- Beard, J, et al.
(författare)
-
Hernia Mesh Repair and Global Surgery
- 2016
-
Ingår i: JAMA surgery. - : American Medical Association (AMA). - 2168-6262 .- 2168-6254. ; 151:12, s. 1191-1191
-
Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
|
|
| 10. |
|
|
