Mesh Versus Patch Repair for Epigastric and Umbilical Hernia (MORPHEUS Trial); One-Year Results of a Randomized Controlled Trial.

DESIGN: This trial is a randomized controlled, patient-blinded, multicentre, superiority trial. METHODS: All patients ≥18 years with a single, symptomatic and primary umbilical or epigastric hernia (<2 fingers) qualified for participation in the study. Flat polypropylene mesh repair was compared to patch repair (PROCEED® Ventral Patch) (PVP). The objective of this trial was to identify a superior method for umbilical and epigastric hernia repair in terms of complication rates. RESULTS: A total of 352 patients were randomized in this trial; 348 patients received the intervention (n = 177 PVP vs. n = 171 mesh). No peri-operative complications occurred. PVP placement was significantly faster compared to mesh placement (30 min, SD 11 vs. 35 min, SD 11) and was scored as an easier procedure. At 1-month follow-up, 76 patients suffered any kind of complication. There was no significant difference in the proportion of complications (24.9% for PVP and 18.7% for mesh, p = 0.195). A significant difference was seen in re-operation rate within 1 month, significantly less early re-operations in the mesh group (0.0 vs. 2.8%, p = 0.027). After 1-year follow-up, no significant differences are seen in recurrence rates (n = 13, 7.8% PVP vs. n = 5, 3.3% mesh, p = 0.08). CONCLUSIONS: Both mesh and PVP had a comparable amount of reported complications. There was a significantly higher incidence of early re-operations due to early complications in the PVP group. No differences were seen in infection rates and the need for antibiotic treatment. No significant difference was seen in the recurrence rates. REGISTRATION: This trial was registered in the Dutch Trail Registry (NTR) NTR2514NL33995.060.10. [12].

Quality of life after Nissen fundoplication in patients with gastroesophageal reflux disease: Comparison between long- and short-term follow-up.

INTRODUCTION:: Nissen fundoplication is the golden standard for surgical treatment of gastroesophageal reflux disease (GERD). Numerous studies report excellent short-term results. However, data regarding long-term quality of life are lacking. The aim of this study is to investigate the long-term quality of life after Nissen fundoplication in patients with GERD and to compare this with the short-term results. PATIENTS AND METHODS: We retrospectively analysed all patients who underwent laparoscopic Nissen fundoplication for GERD between January 2004 and January 2016. All patients received a validated GERD-Health-Related Quality of Life questionnaire by mail to assess post-operative quality of life. Maximum quality of life is represented by a score of 75. Secondary outcome measures were complications and recurrence rate. RESULTS:: One hundred and seventy-five (77.1%) of the 227 operated patients returned the questionnaire. The median follow-up was 3.7 (0.1-10.3) years. Mean age was 51.6 (range 15-85) and 72 patients were male. We report an excellent quality of life with a median total score of 70 (range 2-75). Re-operation rate was 13.6% (23/169); the re-operation was due to recurrent reflux in 12 patients and due to persistent dysphagia in 11 patients. 91.3% of the re-operations were performed within the first 5 years after surgery. Mortality rate was zero. CONCLUSION:: We report a large series of single-centre, single-surgeon laparoscopic Nissen fundoplication. Despite the re-operation rate of 13.6%, we found excellent long-term symptomatic outcome. There was no difference between short- and long-term results.

A collective review of biological versus synthetic mesh-reinforced cruroplasty during laparoscopic Nissen fundoplication.

BACKGROUND: Laparoscopic cruroplasty and fundoplication have become the gold standard in the treatment of hiatal hernia and gastro-oesophageal reflux disease (GERD). The use of a mesh-reinforcement of the cruroplasty has been proven effective; although, there is a lack of evidence considering which type of mesh is superior. The aim of this study was to compare recurrence rates after mesh reinforced cruroplasty using biological versus synthetic meshes. METHODS: We performed a systematic review of all clinical trials published between January 2004 and September 2015 describing the application of a mesh in the hiatal hernia repair during Nissen fundoplication for both GERD and hiatal hernia. The primary outcome was the recurrence rate, and secondary outcomes were complication rate, mortality and symptomatic outcome. RESULTS: We included 16 studies and extracted data regarding 1089 mesh operated patients of whom 385 received a biological mesh and 704 a synthetic mesh. The mean follow-up was 53.4 months. The recurrence rate in the synthetic mesh group was 6.8% compared to 16.1% in the biological mesh group (P < 0.05). The complication rate was 5.1% and 4.6% (P = 0.694), respectively, and there were 12 mesh-related complications. No mesh-related mortality was reported. CONCLUSION: Mesh reinforcement of hiatal hernia repair seems safe in the short-term follow-up. The available literature suggests no clear advantage of biological over synthetic meshes. Regarding cost-efficiency and short-term results, the use of synthetic nonabsorbable meshes might be advocated.

Randomized clinical trial of extended versus single-dose perioperative antibiotic prophylaxis for acute calculous cholecystitis.

BACKGROUND: Many patients who have surgery for acute cholecystitis receive postoperative antibiotic prophylaxis, with the intent to reduce infectious complications. There is, however, no evidence that extending antibiotics beyond a single perioperative dose is advantageous. This study aimed to determine the effect of extended antibiotic prophylaxis on infectious complications in patients with mild acute cholecystitis undergoing cholecystectomy. METHODS: For this randomized controlled non-inferiority trial, adult patients with mild acute calculous cholecystitis undergoing cholecystectomy at six major teaching hospitals in the Netherlands, between April 2012 and September 2014, were assessed for eligibility. Patients were randomized to either a single preoperative dose of cefazolin (2000 mg), or antibiotic prophylaxis for 3 days after surgery (intravenous cefuroxime 750 mg plus metronidazole 500 mg, three times daily), in addition to the single dose. The primary endpoint was rate of infectious complications within 30 days after operation. RESULTS: In the intention-to-treat analysis, three of 77 patients (4 per cent) in the extended antibiotic group and three of 73 (4 per cent) in the standard prophylaxis group developed postoperative infectious complications (absolute difference 0·2 (95 per cent c.i. -8·2 to 8·9) per cent). Based on a margin of 5 per cent, non-inferiority of standard prophylaxis compared with extended prophylaxis was not proven. Median length of hospital stay was 3 days in the extended antibiotic group and 1 day in the standard prophylaxis group. CONCLUSION: Standard single-dose antibiotic prophylaxis did not lead to an increase in postoperative infectious complications in patients with mild acute cholecystitis undergoing cholecystectomy. Registration number: NTR3089 (www.trialregister.nl).

Subjective outcome after laparoscopic hiatal hernia repair for intrathoracic stomach.

PURPOSE: For decades, an intrathoracic stomach (ITS) has been a definite indication for surgery due to the perceived risk of an acute volvulus with perforation, gangrene, or hemorrhage. At the present time, elective laparoscopic repair is the first choice for treatment of ITS. There is a lack of evidence in the long-term quality of life after a hiatal hernia repair for an intrathoracic stomach. METHODS: A retrospective analysis was performed on all patients undergoing a hiatal hernia repair for an intrathoracic stomach between January 2004 and January 2015. Additionally, to a hiatal closure, the patients received an antireflux procedure. Outcome measures included patient characteristics, operative details, complications, and postoperative morbidity and mortality. All patients were sent a quality of life questionnaire to assess long-term quality of life and patient satisfaction. A higher quality of life score represents a better quality of life. RESULTS: Eighty-six patients underwent laparoscopic repair for ITS, from which, one patient died during surgery. Eighty-five patients were contacted and 81 completed the questionnaire, resulting in a response rate of 95.3 %. At a median follow-up of 2.7 years (range 0.1-9.6), the mean quality of life score was 13.5 (standard deviation 2.8). The mean overall satisfaction was 8.4. There were four recurrences: three in the first 12 days after surgery and one in 2.4 years. CONCLUSIONS: Very good results in patient satisfaction and symptom reduction were achieved after a median follow-up of 2.7 years in this laparoscopic repair of the intrathoracic stomach single center experience study. The symptomatic recurrence rate was very low.

An umbilical surprise: a collective review on umbilical pilonidal sinus : An uncommon alternative diagnosis in common umbilical symptoms.

PURPOSE: Umbilical pilonidal sinus (UPS) has an atypical clinical presentation and is therefore not well recognized. The aim of this case series and review of the literature, is to provide more insight in the underlying pathology and a guidance for the treatment of this condition. METHODS: Three recent clinical cases are described that made us perform a multi-database research was to reveal relevant literature. RESULTS: Three relevant clinical cases from our clinic are described. Thirth three studies, describing 463 patients were included. Most studies were case reports or series; few were case series or cohort studies. UPS develops by loose hairs getting caught in the umbilical pit and subsequently penetrate the umbilical cicatrix by friction. In this way an inflammatory response is triggered, resulting in oedema that further narrows the umbilical orifice, hence forming a sinus. Several risk factors are identified. There is no particular consensus on the treatment of this disease. Although older literature advocates immediate umbilical excision without exception, recent studies provide evidence that supports multiple courses of conservative treatment. Several cases were described in which surgery consisted of excision of the sinus and hair tufts in contrast to excision of the entire umbilicus. CONCLUSIONS: Umbilical pilonidal disease has an atypical presentation and might mimic conditions such as incarcerated hernia, Anterior Cutaneous Nerve Entrapment Syndrome or urachal cyst. Risk factors that can bring physicians closer to a reliable diagnosis are identified. An example of a treatment algorithm is provided, suggesting surgery should only be considered when conservative treatment fails.

A consecutive series of 235 epigastric hernias.

BACKGROUND: Epigastric herniation is a common, though not always symptomatic condition. It is likely, that in accordance to the tension-free principles for other hernias, epigastric hernia repair should be mesh based. METHODS: Patients from two large hospitals were investigated retrospectively if they were operated on an epigastric hernia for the past 6 years. Follow-up was completed with a postal questionnaire. RESULTS: A total of 235 patients (50 % male) were operated. Sixty-eight patients were operated with mesh and 167 patients with suture repair. Forty-six patients were loss-to follow-up (19.6 %). In the mesh operated patients the recurrence rate was 10.9 % (n = 6) compared to 14.9 % (n = 20) in the suture repair group. Cox-regression analysis showed an increased risk for recurrence in the suture repair group (odds ratio 1.43; 95 % CI 0.56-3.57; p = 0.44). Operation time for mesh repair (47 min) was significantly longer compared to suture repair (29 min) (p < 0.0001). Thirty-seven patients had previous or other anterior wall hernias. A total of 51 patients smoked and 14 patients had diabetes mellitus. Fourteen patients used steroids and 22 patients suffered from a chronic lung disease. Subgroup analysis showed a significant difference for pain in patients in which re-operation for a recurrence occurred (p = 0.004). CONCLUSIONS: This is one of the largest reported series on solely epigastric hernias. A recurrence occurred more often after sutured repair compared to mesh repair. No differences in chronic pain was seen between mesh and suture repaired patients. Male:female ratio of 1:1, which is different from the 3:1 ratio found in previous older smaller studies, could be more reliable.

Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks for chronic pain after inguinal hernia repair.

PURPOSE: The aim of this study was to evaluate the outcome of ilioinguinal and iliohypogastric nerve blocks in patients with chronic pain after herniorrhaphy, by comparing nerve stimulator and ultrasound guidance to administer the block. METHODS: A total of 43 patients who received nerve blocks for chronic inguinal post-herniorrhaphy pain received standardized questionnaires. Nerve stimulator-guided blocks were performed prior to January 2009, and thereafter, ultrasound-guided blocks were performed using a local anaesthetic solution and a corticosteroid. RESULTS: The questionnaire was completed by 38 patients (88 %). The inguinal hernia repair was performed for a median 16 months (range 3-219) ahead of the nerve blocks. A median of 2 pain treatments (range 1-7) was calculated. Median follow-up was 21 months (range 3-68). According to the DN4, 21 patients (55.3 %) no longer reported neuropathic pain. Subjectively, 32 % no longer reported moderate-to-severe pain. After ultrasound-guided blocks, a higher VAS score (at rest and during activities), a higher proportion of daily pain and more anxiety and depression are reported compared to blocks performed after nerve stimulator guidance. CONCLUSIONS: Ilioinguinal/iliohypogastric nerve blocks can be effective to treat chronic inguinal pain following surgery of the groin. The use of ultrasound was not superior to nerve stimulator-guided blocks. These blocks could be considered prior to more invasive procedures such as neurectomy.

Pathogenesis of the epigastric hernia.

PURPOSE: Epigastric herniation is a rather common condition with a reported prevalence up to 10 %. Only a minority is symptomatic, presumably the reason for the scarce literature on this subject. Epigastric hernias have specific characteristics for which several anatomical theories have been developed. Whether these descriptions of pathological mechanisms still hold with regard to the characteristics of epigastric hernia is the subject of this review. METHODS: A multi-database research was performed to reveal relevant literature by free text word and subject headings 'epigastric hernia', 'linea alba', 'midline' and 'abdominal wall'. Reviewed were studies on anatomical theories describing the pathological mechanism of epigastric herniation, incidence, prevalence and female-to-male ratio and possible explanatory factors. RESULTS: Three different theories have been described of which two have not been confirmed by other studies. The attachment of the diaphragm causing extra tension in the epigastric region is the one still standing. Around 1.6-3.6 % of all abdominal hernias and 0.5-5 % of all operated abdominal hernias is an epigastric hernia. Epigastric hernias are 2-3 times more common in men, with a higher incidence in patients from 20 to 50 years. Some cadaver studies show an epigastric hernia rate of 0.5-10 %. These specific features of the epigastric hernias (the large asymptomatic proportion, male predominance, only above umbilical level) are discussed with regard to the general theories. CONCLUSIONS: The epigastric hernia is a very common condition, mostly asymptomatic. Together with general factors for hernia formation, the theory of extra tension in the epigastric region by the diaphragm is the most likely theory of epigastric hernia formation.