| 1. |
- Analatos, Apostolos, et al.
(författare)
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Clinical Outcomes of a Laparoscopic Total vs a 270 degrees Posterior Partial Fundoplication in Chronic Gastroesophageal Reflux Disease : A Randomized Clinical Trial
- 2022
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Ingår i: JAMA Surgery. - : American Medical Association (AMA). - 2168-6254 .- 2168-6262. ; 157:6, s. 473-480
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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.
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| 2. |
- Analatos, Apostolos, et al.
(författare)
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Evaluation of resection of the gastroesophageal junction and jejunal interposition (Merendino procedure) as a rescue procedure in patients with a failed redo antireflux procedure. A single-center experience
- 2018
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Ingår i: BMC Surgery. - : Springer Science and Business Media LLC. - 1471-2482. ; 18
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Tidskriftsartikel (refereegranskat)abstract
- Background: Primary antireflux surgery has high success rates but 5 to 20% of patients undergoing antireflux operations can experience recurrent reflux and dysphagia, requiring reoperation. Different surgical approaches after failed fundoplication have been described in the literature. The aim of this study was to evaluate resection of the gastroesophageal junction with jejunal interposition (Merendino procedure) as a rescue procedure after failed fundoplication.Methods: All patients who underwent a Merendino procedure at the Karolinska University Hospital between 2004 and 2012 after a failed antireflux fundoplication were identified. Data regarding previous surgical history, preoperative workup, postoperative complications, subsequent investigations and re-interventions were collected retrospectively. The follow-up also included questionnaires regarding quality of life, gastrointestinal function and the dumping syndrome.Results: Twelve patients had a Merendino reconstruction. Ten patients had undergone at least two previous fundoplications, of which one patient had four such procedures. The main indication for surgery was epigastric and radiating back pain, with or without dysphagia. Postoperative complications occurred in 8/12 patients (67%). During a median follow-up of 35 months (range 20-61), four (25%) patients had an additional redo procedure with conversion to a Roux-en-Y esophagojejunostomy within 12 months, mainly due to obstructive symptoms that could not be managed conservatively or with endoscopic techniques. Questionnaires scores were generally poor in all dimensions.Conclusions: In our experience, the Merendino procedure seems to be an unsuitable surgical option for patients who require an alternative surgical reconstruction due to a failed fundoplication. However, the small number of patients included in this study as well as the small number of participants who completed the postoperative workout limits this study.
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| 3. |
- Analatos, Apostolos, et al.
(författare)
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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
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Ingår i: JAMA Surgery. - : American Medical Association (AMA). - 2168-6254 .- 2168-6262. ; 159:1, s. 11-18
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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
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| 4. |
- Analatos, Apostolos
(författare)
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Surgical reconstruction of functional and anatomical defects in the diaphragmatic hiatus
- 2022
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Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
- Gastroesophageal reflux disease (GERD) is characterized mainly by heartburn and acid regurgitation but in the more severe forms even organic manifestations can occur. Proton pump inhibitors (PPIs) is the main medical treatment of GERD but antireflux surgery should be looked upon as an effective long-term therapeutic option. The hiatus hernia (HH) is an important factor in the pathogenesis of GERD since it may disrupt both the anatomy and physiology of the antireflux barrier. The overall aim of this thesis was to critically assess important components in the surgical repair confined to the diaphragmatic hiatus, in patients with HH and with or without GERD. Study I was a double-blind randomized clinical trial in which 159 patients with GERD and HH > 2cm allocated to closure of the hiatal defect with simple crural sutures or with nonabsorbable mesh. The aim of the study was to assess the anatomical and functional outcomes of the use of a mesh for the repair of HH in patients with GERD. Similar anatomical recurrence rates of the HH were noted in the two study groups at 1 year (mesh; 9%, sutures; 3%) and at 3 years (mesh; 13%, sutures; 10%) after the surgery. Both procedures controlled reflux equally well and quality of life scores were comparable. However, more patients had dysphagia for solid food after mesh closure. Study II contained long-term follow up observations of the study I, and assessed the risk for recurrence of HH as well as differences in functional results between the two procedures when assessed more than 10 years later. The mean (SD) follow up of the study was 13 (1.1) years. The radiological recurrence of the HH was 46% in the mesh and 28% in the suture group (p=0.175) but most of the recurrences were small. No differences emerged over time in quality of life between the two procedures but we observed a maintained higher dysphagia scores for solid food items in the mesh group (p=0.011). Study III was a long-term follow up of a randomized double-blind clinical trial of patients with GERD allocated to a total (3600) or partial posterior (2700) fundoplication. The aim of the study was to assess the long-term functional outcomes of these two procedures (>15 years after the operation). The mean (SD) follow up of this study was 16 (1.3) years. The study found that both procedures controlled GERD and quality of life equally well at the time of the follow up with only minor differences in mechanical side effects. Study IV was a double-blind randomized clinical trial conducted in two centers. The aim of the study was to identify any differences between two different types of fundoplication (1800 or 3600) in patients with paraesophageal hernia in terms of early postoperative functional outcomes. In total, 70 patients were included in the study and the follow up was 6 months. Dysphagia was assessed by the Ogilvie and the Dakkak dysphagia scores. The study found that during the follow-up, Ogilvie dysphagia scores were stable in the total fundoplication group but significantly improved in the Toupet group at 3 and 6 months after the operation ( p=0.003 and 0.001, respectively). Moreover, at 6 months, Dakkak dysphagia scores were significantly higher in the total fundoplication group (p=0.003). Finally, there was no difference in reflux control or HH recurrence between the two procedures at the time of the follow-up. In conclusion, tension-free crural repair with non-absorbable mesh in patients with GERD undergoing a Nissen fundoplication does not reduce the risk for radiological recurrence of the HH in the short- or the long-term. In addition, the finding of maintained higher dysphagia scores at 13 years postoperatively in the mesh group, implies that PTFE mesh closure cannot be recommended for routine use in HH repair associated with antireflux surgery. Both the total and the partial posterior fundoplication control GERD and quality of life well when assessed as long as 15 years after surgery. The addition of a total fundoplication in patients with paraesophageal hernia undergoing surgery, may be burdened by higher risk for postoperative dysphagia.
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| 5. |
- Analatos, Apostolos, et al.
(författare)
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Tension-free mesh versus suture-alone cruroplasty in antireflux surgery : a randomized, double-blind clinical trial
- 2020
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Ingår i: British Journal of Surgery. - : John Wiley & Sons. - 0007-1323 .- 1365-2168. ; 107:13, s. 1731-1740
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundAntireflux surgery is effective for the treatment of gastro-oesophageal reflux disease (GORD) but recurrence of hiatal hernia remains a challenge. In other types of hernia repair, use of mesh is associated with reduced recurrence rates. The aim of this study was to compare the use of mesh versus sutures alone for the repair of hiatal hernia in laparoscopic antireflux surgery.MethodsPatients undergoing laparoscopic Nissen fundoplication for GORD between January 2006 and December 2010 were allocated randomly to closure of the diaphragmatic hiatus with crural sutures or non-absorbable polytetrafluoroethylene mesh (CruraSoft®). The primary outcome was recurrence of hiatal hernia, as determined by barium swallow study 12 months after surgery. Secondary outcomes were: intraoperative and postoperative complications, use of antireflux medication, postoperative oesophageal acid exposure, quality of life, dysphagia and duration of hospital stay.ResultsSome 77 patients were randomized to the suture technique and 82 patients underwent mesh repair. At 1 year, the hiatal hernia had recurred in six of 64 patients (9 per cent) in the mesh group and two of 64 (3 per cent) in the suture group (P = 0·144). Reflux symptoms, use of proton pump inhibitors and oesophageal acid exposure did not differ between the groups. At 3 years, recurrence rates were 13 and 10 per cent in the mesh and suture groups respectively (P = 0·692). Dysphagia scores decreased in both groups, but more patients had dysphagia for solid food after mesh closure (P = 0·013). Quality-of-life scores were comparable between the groups.ConclusionTension-free crural repair with non-absorbable mesh does not reduce the incidence of recurrent hiatal hernia compared with use of sutures alone in patients undergoing laparoscopic fundoplication. NCT03730233 (http://www.clinicaltrials.gov).
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| 6. |
- Analatos, Apostolos, et al.
(författare)
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Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias : randomized clinical trial
- 2022
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Ingår i: BJS Open. - : Oxford University Press (OUP). - 2474-9842. ; 6:3
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Tidskriftsartikel (refereegranskat)abstract
- Background: Fundoplication is an essential step in para-oesophageal hernia (POH) repair, but which type minimizes postoperative mechanical complications is controversial.Methods: This was a randomized, double-blind clinical trial conducted between May 2009 and October 2018. Patients with symptomatic POH were allocated to either a total (Nissen) or a posterior partial (Toupet) fundoplication after hernia reduction and crural repair. The primary outcome was dysphagia (Ogilvie dysphagia scores) at 6 months postoperatively. Secondary outcomes were peri- and postoperative complications, swallowing difficulties assessed by the Dakkak dysphagia score, gastro-oesophageal reflux, quality of life (QoL), and radiologically confirmed hernia recurrence.Results: A total of 70 patients were randomized to a Nissen (n = 32) or a Toupet (n = 38) fundoplication. Compared with baseline, Ogilvie dysphagia scores were stable at the 3- and 6-month follow-up in the Nissen group (P = 0.075 and 0.084 respectively) but significantly improved in the Toupet group (from baseline mean (s.d.): 1.4 (1.1) to 0.5 (0.8) at 3 months, and 0.5 (0.6) at 6 months; P= 0.003 and P = 0.001 respectively). At 6 months, Dakkak dysphagia scores were significantly higher in the Nissen group than in the Toupet group (mean (s.d.): 10.4 (7.9) versus 5.1(7.2); P = 0.003). QoL scores improved throughout the follow-up. However, at 3 and 6 months postoperatively, the absolute median improvement (A) from preoperative values in the mental component scores of the Short Form-36 QoL questionnaire was significantly higher in the Toupet group (median (i.q.r.): 7.1 (-0.6 to 15.2) versus 1.0 (-5.4 to 3.3) at 3 months, and 11.2 (1.4 to 18.3) versus 0.4 (-9.4 to 7.5) at 6 months; (P =0.010 and 0.003 respectively)). At 6 months, radiologically confirmed POH recurrence occurred in 11 of 24 patients (46 per cent) of the Nissen group and in 15 of 32 patients (47 per cent) of the Toupet group (P = 1.001).Conclusions: A partial posterior wrap (Toupet fundoplication) showed reduced obstructive complications and improved QoL compared with a total (Nissen) fundoplication following POH repair.
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