Impact of Laparoscopic Repair of Large Hiatus Hernia on Quality of Life: Observational Cohort Study.

BACKGROUND: Laparoscopic surgery has proven safe and effective in the treatment of large hiatus hernia. Differences may exist between objectively assessed surgical outcomes, symptomatic scores, and patient-reported outcomes. METHODS: An observational, single-arm cohort study was conducted in patients undergoing primary laparoscopic repair with crura mesh augmentation and Toupet fundoplication for large (> 50% of intrathoracic stomach) type III-IV hiatus hernia. Data were extracted from hospital charts and a prospectively updated research database. The main study outcome was quality of life assessed by the Gastroesophageal reflux disease Health-Related Quality of Life (GERD-HRQL) score and the Short-form 36 (SF-36). RESULTS: Between 2013 and 2016, 37 out of 49 operated patients completed the comprehensive quality-of-life evaluation at the 2-year follow-up. The GERD-HRQL score significantly decreased compared to baseline (p < 0.001). All items of the SF-36 significantly improved compared to baseline (p < 0.05). Both Physical and Mental Component Summary scores were significantly higher than preoperative scores, with a medium Cohen's effect size (-0.77 and 0.56, respectively). At the 2-year follow-up, symptoms had disappeared in the majority of patients. The use of proton-pump inhibitors significantly decreased compared to baseline (13.5 vs. 86.4%, p < 0.001). Also, the use of antidepressants and benzodiazepines significantly decreased after surgery (8.1 vs. 32.4%, p < 0.001). The overall alimentary satisfaction score was > 8 in 92% of patients. There were no safety issues related to the use of the absorbable synthetic mesh. The incidence of anatomical hernia recurrence was 5.4%, but no patient with recurrent hernia required surgical revision. CONCLUSIONS: Laparoscopic repair of large hiatus hernia with mesh and partial fundoplication is associated with symptomatic relief, no side-effects, and a significant improvement in disease-specific and generic quality of life at 2-year follow-up.

Utility of C-reactive protein as predictive biomarker of anastomotic leak after minimally invasive esophagectomy.

BACKGROUND: Early detection of anastomotic leakage after esophagectomy has the potential to reduce morbidity and mortality. Prompt suspicion of leak may help to exclude patients from fast-track protocols, thereby avoiding early oral feeding and early hospital discharge which could aggravate the prognosis of a clinically occult leak. PATIENTS AND METHODS: Observational retrospective cohort study. Patients with diagnosis of esophageal cancer who underwent elective minimally invasive esophagectomy were included. The following data were collected: age, gender, BMI, comorbidities, ASA score, tumor histology, TNM staging, use of neo-adjuvant therapy, type of operation, operative time, morbidity, and 90-day mortality. A panel of biomarkers including C-reactive protein (CRP), procalcitonin (PCT), white blood cells (WBC), and percentage of neutrophils (PN) were measured at baseline and on postoperative days 3, 5, and 7. RESULTS: Two hundred forty-three patients operated between 2012 and 2017 were included in the study. Anastomotic leakage occurred in 29 patients. There was a statistical association over time between anastomotic leakage and CRP (p < 0.001), PCT (p < 0.001), WBC (p = 0.019), and PN (p = 0.007). The cut-off value of CRP on POD 5 was 8.3 mg/dL, AUC = 0.818, negative LR = 0.176. CONCLUSIONS: Increased serum CRP, PCT, WBC, and PN after minimally invasive esophagectomy are associated with anastomotic leakage. A CRP value lower than 8.3 mg/dL, combined with reassuring clinical and radiological signs, may be useful to exclude leakage on postoperative day 5.

Removal of the Magnetic Sphincter Augmentation Device: Surgical Technique and Results of a Single-center Cohort Study.

OBJECTIVE: The aim of this study was to identify patients' characteristics that may predict failure and removal of the Linx sphincter augmentation device, and to report the results of 1-stage laparoscopic removal and fundoplication. BACKGROUND: The Linx device is a long-term magnetic implant that was developed as a less disruptive and more reproducible surgical option for patients with early-stage gastroesophageal reflux disease (GERD). Removal of the device has been shown to be feasible, but no long-term results of this procedure have been reported yet. METHODS: A review of the prospectively collected research database of antireflux surgery was performed to identify all patients who underwent a Linx implant between 2007 and 2015 in our Institution. Demographics, duration of symptoms and proton pump inhibitor (PPI) therapy, GERD-Health Related Quality of Life scores, esophageal acid exposure, lower esophageal sphincter pressure, number of beads (size) of the implanted device, concurrent crura repair, angle of inclination of the device at postoperative chest film, operative time, postoperative complications, and length of stay were recorded. Data of the explanted patients were compared with those with the device in situ in an attempt to identify factors associated with Linx removal. RESULTS: Over the study period, 164 patients underwent a laparoscopic Linx implant and had a median follow-up of 48 months [interquartile range (IQR) 36]. Eleven (6.7%) of these patients were explanted at a later date. The estimated removal-free probability at 80 months was 0.91 [confidence interval (CI) 0.86-0.96]. Supine esophageal acid exposure before the index operation was associated with Linx removal (odds ratio 1.05, CI 1.01-1.11, P = 0.037). The main presenting symptom requiring device removal was recurrence of heartburn or regurgitation in 5 patients (46%), followed by dysphagia (n = 4, 37%) and chest pain (n = 2, 18%). In 2 patients, full-thickness erosion of the esophageal wall with partial endoluminal penetration of the device occurred. The median implant duration was 20 months, with 82% of the patients being explanted between 12 and 24 months after the implant. Device removal was most commonly combined with partial fundoplication. There were no conversions to laparotomy and the postoperative course was uneventful in all patients. At the latest follow-up, ranging from 12 to 58 months, the GERD-HRQL score was within normal limits in all patients. CONCLUSIONS: Laparoscopic removal of the Linx device can be safely performed as a 1-stage procedure and in conjunction with fundoplication even in patients presenting with device erosion.

Laparoscopic management of large hiatus hernia: five-year cohort study and comparison of mesh-augmented versus standard crura repair.

OBJECTIVES: To evaluate objective and subjective outcomes of patients undergoing laparoscopic repair of large hiatal hernia, either with or without resorbable mesh augmentation. The primary outcome of the study was anatomical recurrence rate as measured by endoscopy. Secondary outcomes were safety, efficacy, and long-term quality of life. METHODS: This was an observational cohort study. Patients who underwent laparoscopic repair of large (≥5 cm) type III hiatal hernia were included. Criteria of exclusion were previously failed hiatus hernia repair and emergency procedures. Patients were stratified into mesh group (mesh-augmented crura repair plus fundoplication) and non-mesh group (standard crura repair plus fundoplication). Preoperative and postoperative symptoms were assessed using the GERD-HRQL questionnaire. Upper gastrointestinal endoscopy was routinely performed between 6 and 12 months postoperatively and was repeated over the follow-up every 1-2 years or as needed. Anatomical hernia recurrence was defined as the maximum vertical length of stomach being at least 2 cm above the diaphragm. RESULTS: A total of 84 patients, 41 in the mesh group and 43 in the non-mesh group, operated between October 2009 and October 2014, were included in the study. All surgical procedures were completed laparoscopically. The median follow-up was 24 (IQR 29) months. There were 12 endoscopic recurrences, 4 in the mesh group and 8 in the non-mesh group. The five-year recurrence-free probability was similar in the two groups, but an earlier failure rate was noted in the non-mesh group at 12 months (p = 0.299). Three of the 12 patients with anatomical recurrence were symptomatic but did not require a reoperation. Univariate Cox proportional hazard analysis indicated that Toupet fundoplication may reduce the recurrence rate compared to Nissen fundoplication. No mesh-related complications occurred. CONCLUSIONS: Laparoscopic repair of large hiatal hernia is effective and durable. Crura reinforcement with a resorbable synthetic mesh is safe and may protect from early anatomical recurrence.

Trajectories of Health-Related Quality of Life, Health Literacy, and Self-Efficacy in Curatively-Treated Patients with Esophageal Cancer: A Longitudinal Single-Center Study in Italy.

This prospective longitudinal study aimed to describe the trajectories of HRQoL, health literacy, and self-efficacy in patients with esophageal cancer, which have been thus far poorly described. Data were collected at baseline (preoperative phase) and in the postoperative period (two weeks, and one, two, and three months after esophagectomy). The study hypothesis was that health literacy and self-efficacy might predict better health status and quality of life over time. Forty-five patients were enrolled between 2018 and 2019. HRQoL, health literacy, and self-efficacy were assessed using validated scales. The ability to analyze information to exert greater control over life events critically (critical health literacy) (η2 p = 0.660) and the individual's confidence in dealing with challenging tasks (self-efficacy) (η2 p = 0.501) strongly predicted the scores of general health status over time. Overall, the functional status improved at 3 months after surgery, and this trend paralleled the decline of cancer-specific and surgery-related symptoms. In conclusion, researchers and clinicians should pay greater attention to optimizing baseline health literacy and self-efficacy levels. Future educational and motivational interventions should be further tested and possibly integrated into the prehabilitation programs.

Safety and Efficacy of Crura Augmentation with Phasix ST Mesh for Large Hiatal Hernia: 3-Year Single-Center Experience.

Background: Safety and effectiveness of absorbable meshes for laparoscopic hiatus hernia repair are still debated. This may be due to patient selection, technique of repair, type and shape of mesh, definition of recurrent hernia, and length of follow-up. The aim of this study was to assess safety, short-term efficacy, and quality of life after laparoscopic repair of hiatal hernia reinforced with a biosynthetic absorbable mesh. Materials and Methods: A single-center observational cohort study was conducted in patients with large type III-IV hiatal hernia who underwent laparoscopic crural repair reinforced with Phasix ST®, a monofilament resorbable mesh (poly-4-hydroxybuterate) with a hydrogel barrier on one side. Patient data were extracted from hospital charts and a prospectively updated research database. Both generic Short Form-36 (SF-36) and disease-specific (Gastro-Esophageal Reflux Disease Health-Related Quality of Life [GERD-HRQL]) questionnaires were used to assess preoperative and postoperative quality of life. Results: From January 2017 to July 2019, 73 consecutive patients were implanted with Phasix ST mesh. The median follow-up was 17 (interquartile range 9-24) months. Recurrent hernia was found in 2 of 62 (3.2%) patients followed for more than 6 months after surgery, but none required reoperation. The overall postoperative morbidity rate was 8.2%. No mesh-related complications occurred. Compared to baseline, there was a statistically significant improvement of all items of the SF-36 questionnaire (P < .001) and of the median GERD-HRQL score (P < .001). Conclusion: The use of Phasix ST mesh to reinforce crural repair for large hiatus hernias is safe, is effective in the short-term follow-up, and is associated to improved quality of life.

Computed tomography-derived myocardial extracellular volume: an early biomarker of cardiotoxicity in esophageal cancer patients undergoing radiation therapy.

OBJECTIVES: We aimed to assess extracellular volume (ECV) through non-gated, contrast-enhanced computed tomography (CT) before and after radiation therapy (RT) in patients with esophageal cancer (EC). MATERIALS AND METHODS: EC patients who had undergone CT before and after RT were retrospectively assessed. Patients with preexisting cardiovascular disease or with heavily artifacted CT were excluded. ECV was calculated using density values for the myocardial septum and blood pool. Data were reported as mean and standard deviation or median and interquartile range according to their distribution; t test or Wilcoxon and Pearson r or Spearman ρ were subsequently used. RESULTS: Twenty-one patients with stage ≥ IB EC, aged 64 ± 18 years, were included. Mean and maximum RT doses were 21.2 Gy (16.9-24.1) and 42.5 Gy (41.8-49.2), respectively. At baseline (n = 21), hematocrit was 39% ± 4%, ECV 27.9% ± 3.5%; 35 days (30-38) after RT (n = 20), hematocrit was 36% ± 4%, lower than at baseline (p = 0.002), ECV 30.3% ± 8.3%, higher than at baseline (p = 0.081); at follow-up 420 days (244-624) after RT (n = 13), hematocrit was 36% ± 5%, lower than at baseline (p = 0.030), ECV 31.4% ± 4.5%, higher than at baseline (p = 0.011). No patients showed signs of overt cardiotoxicity. ECV early after RT was moderately positively correlated with maximum RT dose (ρ = 0.50, p = 0.036). CONCLUSIONS: In EC patients, CT-derived myocardial ECV was increased after RT and may thus appear as a potential early biomarker of cardiotoxicity.

[Self-expanding oesophageal stents: comparison of Ultraflex and Choostent]. / Endoprotesi esofagee autoespansibili: studio di confronto tra Ultraflex e Choostent.

Two types of covered self-expanding metal stents were compared in a consecutive series of 57 patients. Stent placement was successful in all patients. No procedure-related deaths were observed. The overall hospital morbidity was 7%. No significant differences in the efficacy of palliation of dysphagia, rate of complications, and survival rates were seen using the two types of stent. An endoscopic reintervention was required in 14% of the patients. Both stents proved to be safely removable in the short term follow-up, and the benefit of temporary insertion was documented in patients with primary oesophageal neoplasms prior to chemotherapy or chemoradiation therapy and in those with anastomotic strictures/leaks. A multidisciplinary strategy, guided by the concept that a stent should not represent the only, definitive treatment modality, may improve the quality of life of patients with advanced oesophageal carcinoma.

Magnetic sphincter augmentation for gastroesophageal reflux disease: review of clinical studies.

Use of the magnetic sphincter augmentation (MSA) device for the laparoscopic treatment of gastroesophageal reflux disease is increasing since the first clinical implant performed a decade ago. The MSA procedure is a minimally invasive and highly standardized surgical option for patients who are partially responders to proton-pump inhibitors, which have troublesome regurgitation or develop progressive symptoms despite continuous medical therapy. The procedure has proven to be highly effective in improving typical reflux symptoms, reducing the use of proton-pump inhibitors, and decreasing esophageal acid exposure. Observational cohort studies have shown that MSA compares well with fundoplication in selected patients and has an acceptable safety profile. The device can be easily removed if necessary, thereby preserving the option of fundoplication in the future. The majority of the removals have occurred within 2 years after implant and have been managed non-emergently, with no complications or long-term consequences. "Expanded" indications to MSA (large hiatal hernia and Barrett's esophagus) need to be tested in further comparative studies with classic fundoplication procedures.

Transhiatal Chest Drainage After Hybrid Ivor Lewis Esophagectomy: Proof of Concept Study.

BACKGROUND: Intercostal pleural drainage is standard practice after transthoracic esophagectomy but has some drawbacks. We hypothesized that a transhiatal pleural drain introduced through the subxyphoid port site incision at laparoscopy can be as effective as the intercostal drainage and may enhance patient recovery. PATIENTS AND METHODS: A proof of concept study was designed to assess a new method of pleural drainage in patients undergoing hybrid Ivor Lewis esophagectomy (laparoscopy and right thoracotomy). The main study aims were safety and efficacy of transhiatal pleural drainage with a 15 Fr Blake tube connected to a portable vacuum system. Pre- and postoperative data, mean duration, and total and daily output of drainage were recorded in an electronic database. Postoperative complications were scored according to the Dindo-Clavien classification. RESULTS: Between June 2015 and December 2016, 50 of 63 consecutive patients met the criteria for inclusion in the study. No conversions from the portable vacuum system to underwater seal and suction occurred. There was no mortality. The overall morbidity rate was 40%. Two patients (4%) required reoperation for hemothorax and chylothorax, respectively. Percutaneous catheter drainage for residual pneumothorax was necessary in 2 patients (4%) on postoperative day 2. The mean duration of drainage was 7 days (interquartile range [IQR] = 2), and the total volume of drain output was 1580 mL (IQR = 880). No pleural effusion on chest X-ray was detected at the 3-month follow-up visit. CONCLUSIONS: Transhiatal pleural drainage is safe and effective after hybrid Ivor Lewis esophagectomy and could replace the intercostal drain in selected patients.

Hybrid and total minimally invasive esophagectomy: how I do it.

Esophagectomy is a major surgical procedure associated with a significant risk of morbidity and mortality. Minimally invasive esophagectomy is becoming the preferred approach because of the potential to limit surgical trauma, reduce respiratory complications, and promote earlier functional recovery. Various hybrid and total minimally invasive surgical techniques have been introduced in clinical practice over the past 20 years, and minimally invasive esophagectomy has been shown equivalent to open surgery concerning the short-term outcomes. Implementation of a minimally invasive esophagectomy program is technically demanding and requires a significant learning curve and the infrastructure of a dedicated multidisciplinary center where optimal staging, individualized therapy, and perioperative care can be provided to the patient. Both hybrid and total minimally invasive techniques of esophagectomy have proven safe and effective in expert centers. The choice of the surgical approach should be driven by preoperative staging, tumor site and histology, comorbidity, patient's anatomy and physiological status, and surgeon's experience.

Health-related quality of life after laparoscopic Heller myotomy and Dor fundoplication for achalasia.

BACKGROUND: In addition to symptom scores, a person's perception of health and quality of life assessment is an important indicator of quality of treatment and can provide an efficient index to compare different therapeutic modalities in chronic disease states. Only a few studies have investigated quality of life comprehensively in patients with achalasia, and therefore the controversy regarding the best treatment algorithm continues. The primary study outcome was pre- and postoperative quality of life in patients with achalasia undergoing laparoscopic Heller myotomy and Dor fundoplication. METHODS: The study is a retrospective, observational cohort. The hospital registry and the updated research database were reviewed to identify all patients who were treated for achalasia between 2010 and 2015. Patients were eligible for the study if they had a minimum 1-year follow-up and had pre-and postoperative Eckardt, Short Form-36, and Gastro-Esophageal Reflux Disease Health-Related Quality of Life scores. Patients with previous operative and/or endoscopic treatments for achalasia were excluded. RESULTS: One-hundred and eighteen patients were identified. The median follow-up was 40 months (interquartile range 27). The proportion of patients with Eckardt stage II-III decreased from 94.9-13% (P < .001). The mean Eckardt score decreased from 6.9 ± 1.9 to 1.7 ± 1.2 (P < .001); the mean Short Form-36 scores significantly increased in all 8 domains; the mean Gastro-Esophageal Reflux Disease Health-Related Quality of Life score decreased from 13.9 ± 5.7 to 5.5 ± 5.4 (P < .001). Finally, 88% (confidence interval 81-93) of patients were satisfied regarding their present condition. CONCLUSION: Quality of life assessed with generic and disease-specific validated instruments significantly improved after laparoscopic Heller myotomy combined with Dor fundoplication.

Open Versus Laparoscopic Management of Incisional Abdominal Hernia: Cohort Study Comparing Quality of Life Outcomes.

BACKGROUND AND AIMS: Incisional hernia is a common complication of laparotomy. The long-term effectiveness of the laparoscopic repair compared to the open approach remains to be proven. We investigated the 1-year impact of open and laparoscopic repair of incisional hernia on quality of life outcomes. METHODS: Single-center cohort study. The clinical data of patients who underwent open or laparoscopic surgery for primary midline incisional hernia were retrieved from hospital records and from a research database. Criteria of exclusion were emergency procedures, associated bowel resection, and recurrent incisional hernia. Complications and recurrence rates were analyzed. The visual analog scale (VAS) and the Short-Form 36 (SF-36) were used to assess pain and quality of life 1 year after surgery in patients free of recurrence. RESULTS: One hundred twenty-four patients were eligible for inclusion in the study. The mean follow-up was 3 ± 2 years (interquartile range [IQR] 2.0). Overall, 9% of patients in the open group and 7% in the laparoscopic group presented with hernia recurrence (P = .685). Sixty-six of the 124 patients, who were operated between 2009 and 2014 by the same surgical team with expertise in advanced laparoscopic surgery, were considered for the study. Nine (14%) of these patients were lost to follow-up and three (5%) had a recurrent hernia, reducing the final sample size to 54 patients of whom 26 operated through an open approach and 28 through laparoscopy. The two groups were comparable according to demographic variables, comorbidity, and postoperative morbidity. The laparoscopic approach required less operative time (<.001) and length of hospital stay (P = .002). The VAS and the SF-36 scores were similar in the 54 patients, 26 in the open group and 28 in the laparoscopic group, who completed the 1-year assessment. CONCLUSIONS: Health-related quality of life at 1 year was similar in patients undergoing open or laparoscopic repair of incisional abdominal hernia.

Light Augmentation Device: A New Surgical Tool for Improved Laparoscopic Visibility and Transillumination: Proof-of-Concept Study.

The light augmentation device (LAD®) is a new disposable tool designed to improve observation by transillumination in laparoscopic surgery. It can be introduced into the abdomen through an 11-12 mm port as a supplementary light source. The miniaturized design allows the surgeon to pick up the device with an endograsper and to place it under direct vision where needed. This proof-of-concept study demonstrated safety and efficacy of the device in the animal model.

Early outcome of thoracoscopic and hybrid esophagectomy: Propensity-matched comparative analysis.

BACKGROUND: Transthoracic esophagectomy remains the current therapeutic standard for localized esophageal carcinoma. Minimally invasive surgery has proven at least equivalent to open surgery regarding the early outcomes, but only 1 randomized study has compared the thoracoscopic with the thoracotomy approach. The primary objective of this study was to assess the early outcome of the thoracoscopic prone esophagectomy (TPE) and the hybrid Ivor Lewis (HIL) esophagectomy in 2 concurrent patient cohorts. METHODS: We compared the 1-year outcome of 3-stage TPE and 2-stage HIL done over the same time period in a single center. The propensity score matching method was used to reduce selection bias by creating 2 groups of patients similarly likely to receive a treatment on the basis of measured baseline characteristics. After generating propensity scores using the covariates of age, sex, body mass index, forced expiration volume at 1 second, Charlson comorbidity index, American Society of Anesthesiologists score, histologic tumor type, tumor site, pTNM stage, and neoadjuvant therapy, 93 TPE patients were matched with 197 HIL patients using a 1:1 ratio and the nearest-neighbor score matching. Main outcome measure was the incidence of postoperative complications. RESULTS: Operative time was longer in TPE patients (P < .01). All postoperative outcomes, including morbidity, mortality, nodal harvest, R0 resection rate, and 1-year survival rates were similar in the 2 matched groups. CONCLUSION: Both operative approaches are safe and effective; using 1 or the other depends on the tumor site, surgeon experience and preference, and patient expectations.

Toothpick ingestion complicated by cecal perforation: case report and literature review.

BACKGROUND: Diverticulitis and carcinoma represent the most common causes of colon perforation, but other causes, like ingestion of foreign bodies, should be taken into account. CASE PRESENTATION: We report the case of a 64-year old man presenting in our Emergency Department with a 2 days history of right lower abdominal pain, nausea, vomiting and low grade fever. Physical examination evocated mild pain with positive rebound tenderness in the right lower abdominal quadrant, and positive right costovertebral angle tenderness. Routine blood tests, abdominal X-rays and CT scan were inconclusive for perforation. At explorative laparoscopy a cecal perforation with localized peritonitis was found, and a right colectomy was performed due to the suspicion of cancer. Histological examination confirmed the presence of a perforation caused by a piece of wood (toothpick) of 6 cm in length. CONCLUSIONS: Foreign body ingestion should be taken into account in the evaluation of acute abdominal pain. A detailed patient's history may be crucial for a correct diagnosis and treatment.

One hundred consecutive patients treated with magnetic sphincter augmentation for gastroesophageal reflux disease: 6 years of clinical experience from a single center.

BACKGROUND: This study was undertaken to evaluate our clinical experience during a 6-year period with an implantable device that augments the lower esophageal sphincter for gastroesophageal reflux disease (GERD). The device uses magnetic sphincter augmentation (MSA) to strengthen the antireflux barrier. STUDY DESIGN: In a single-center, prospective case series, 100 consecutive patients underwent laparoscopic MSA for GERD between March 2007 and February 2012. Clinical outcomes for each patient were tracked post implantation and compared with presurgical data for esophageal pH measurements, symptom scores, and proton pump inhibitor (PPI) use. RESULTS: Median implant duration was 3 years (range 378 days to 6 years). Median total acid exposure time was reduced from 8.0% before implant to 3.2% post implant (p < 0.001). The median GERD Health Related Quality of Life score at baseline was 16 on PPIs and 24 off PPIs and improved to a score of 2 (p < 0.001). Freedom from daily dependence on PPIs was achieved in 85% of patients. There have been no long-term complications, such as device migrations or erosions. Three patients had the device laparoscopically removed for persistent GERD, odynophagia, or dysphagia, with subsequent resolution of symptoms. CONCLUSIONS: Magnetic sphincter augmentation for GERD in clinical practice provides safe and long-term reduction of esophageal acid exposure, substantial symptom improvement, and elimination of daily PPI use. For candidates of antireflux surgery who have been carefully evaluated before surgery to confirm indication for MSA, MSA has become a standard treatment at our institution because control of reflux symptoms and pH normalization can be achieved with minimal side effects and preservation of gastric anatomy.