Five-Year Follow-Up of a Slowly Resorbable Biosynthetic P4HB Mesh (Phasix) in VHWG Grade 3 Incisional Hernia Repair.

Objective: To assess the 5-year recurrence rate of incisional hernia repair in Ventral Hernia Working Group (VHWG) 3 hernia with a slowly resorbable mesh. Summary Background Data: Incisional hernia recurs frequently after initial repair. In potentially contaminated hernia, recurrences rise to 40%. Recently, the biosynthetic Phasix mesh has been developed that is resorbed in 12-18 months. Resorbable meshes might be a solution for incisional hernia repair to decrease short- and long-term (mesh) complications. However, long-term outcomes after resorption are scarce. Methods: Patients with VHWG grade 3 incisional midline hernia, who participated in the Phasix trial (Clinilcaltrials.gov: NCT02720042) were included by means of physical examination and computed tomography (CT). Primary outcome was hernia recurrence; secondary outcomes comprised of long-term mesh complications, reoperations, and abdominal wall pain [visual analogue score (VAS): 0-10]. Results: In total, 61/84 (72.6%) patients were seen. Median follow-up time was 60.0 [interquartile range (IQR): 55-64] months. CT scan was made in 39 patients (68.4%). A recurrence rate of 15.9% (95% confidence interval: 6.9-24.8) was calculated after 5 years. Four new recurrences (6.6%) were found between 2 and 5 years. Two were asymptomatic. In total, 13/84 recurrences were found. No long-term mesh complications and/or interventions occurred. VAS scores were 0 (IQR: 0-2). Conclusions: Hernia repair with Phasix mesh in high-risk patients (VHWG 3, body mass index >28) demonstrated a recurrence rate of 15.9%, low pain scores, no mesh-related complications or reoperations for chronic pain between the 2- and 5-year follow-up. Four new recurrences occurred, 2 were asymptomatic. The poly-4-hydroxybutyrate mesh is a safe mesh for hernia repair in VHWG 3 patients, which avoids long-term mesh complications like pain and mesh infection.

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.

INTRODUCTION: Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. METHODS: A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. RESULTS: Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. CONCLUSION: After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. TRIAL REGISTRATION: Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol.

BACKGROUND: Incisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients. METHODS: A total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site Occurrence (SSO) including hematoma, seroma, infection, dehiscence and fistula formation (requiring intervention) through 3 months. Secondary outcomes include recurrence, infection and quality of life related outcomes after 24 months. Follow-up visits will be at drain removal (if drains were not placed, then on discharge or staple removal instead) and in the 1st, 3rd, 6th, 12th, 18th and 24th month after surgery. CONCLUSION: Based on evidence from this clinical study Depending on the results this clinical study will yield, Phasix™ Mesh may become a preferred treatment option in VHWG Grade 3 patients. TRIAL REGISTRATION: The trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042 .

Transanal endoscopic microsurgery is superior to transanal excision of rectal adenomas.

AIM: Comparison of transanal excision (TE) and transanal endoscopic microsurgery (TEM) of rectal adenomas (RA) has rarely been performed. METHOD: From 1990 to 2007, the results of TE (43 RA) and TEM (216 RA) were compared. Rectal adenomas were matched for diameter and distance from the anal verge. RESULTS: Operation time was 47.5 min for TE and 35 min for TEM (P < 0.001). Morbidity was 10% after TE and 5.3% after TEM (P < 0.001). Negative resection margins were observed in 50% after TE and 88% after TEM (P < 0.001). Fragmentation of the excised specimen was observed in 23.8% after TE and 1.4% after TEM (P < 0.001). In cases of fragmentation, positive resection margins were observed more frequently. Recurrence was 28.7% after TE and 6.1% after TEM (P < 0.001). After TE, RA with a negative resection margin had a local recurrence rate of 0%, compared with 59.6% with a positive margin (P < 0.001), and after TEM these rates were 3.2 and 7.7% (P = 0.3), respectively. CONCLUSION: Transanal endoscopic microsurgery is superior to transanal excision of RA.

Introduction of preoperative radiotherapy in the treatment of operable rectal cancer in the Southwest region of the Netherlands.

INTRODUCTION: After publication of the results of the Dutch TME-trial preoperative radiotherapy followed by TME-surgery was introduced in July 2001 in the region of the comprehensive cancer centre Rotterdam as standard treatment for rectal cancer. The aim of this study is to identify the compliance to a new standardized treatment protocol i.e. the introduction of preoperative radiotherapy and to analyze the results of rectal cancer treatment in the Cancer Centre Rotterdam Region. PATIENTS AND METHODS: A total of 521 patients with adenocarcinoma of the rectum were included in the period from 2001 to 2003. All patients were treated with curative intent. RESULTS: There was a significant increase of preoperative radiotherapy for patients with a tumour in the lower two-third of the rectum (21% versus 69%, p<0.001). Peri-operative mortality rate was 2.7% and overall anastomotic leakage rate was 10.3%. There was a significant increase in the occurrence of anastomotic leakage in end-to-end anastomoses (p<0.0001). Most anastomotic leakages occurred when patients were operated in between 4 and 8 days after the end of radiotherapy. Several aspects such as continence for urine and faeces and sexual functions were poorly registered. The total number of lymph nodes registered in pathology reports was low. The rate of reported circumferential margins increased from 37% to 70% after feedback to the regional pathology working group. CONCLUSION: The regional quality of rectal cancer surgery is conform preset quality-demands. There was a significant increase in the percentage preoperative radiotherapy, but still about 25% of patients who qualified for radiotherapy did not receive radiation. Pathology reports improved during registration, which illustrates the importance of registration to assess and improve quality of rectal cancer treatment.

Ultracision Harmonic Scalpel and multifunctional tem400 instrument complement in transanal endoscopic microsurgery: a prospective study.

BACKGROUND: For transanal endoscopic microsurgery, the ultracision Harmonic Scalpel (UC) and the multifunctional TEM400 instrument (T400) seem advantageous. This study investigated their clinical use. METHODS: Prospective analysis of tumor, patient, and operation characteristics was performed for 196 tumor resections per instrument intended for application. RESULTS: The T400 instrument was applied in 162 operations, and the UC in 34 operations. Tumor and patient characteristics were similar except for tumor area (respectively, 7.5 and 17 cm(2); p = 0.003). Operative time was proportionate to the tumor area (p < 0.001) and inversely proportionate to its distance from the dentate line to the lower margin of the tumor of the UC (p = 0.002). Application reduced operative time by 26% (p = 0.02, corrected for area). Whereas, T400 was always singly sufficient for excision, the UC required T400 application in 50% of operations, especially for larger tumors (p = 0.026), with the result that more rectal wall circumference was captured (p = 0.043). Both groups had similar safety parameters. CONCLUSIONS: The UC substantially reduced operative time compared with the T400, but frequently required the T400 for procedure completion. The T400 is always singly sufficient.

Use of head-mounted display in transanal endoscopic microsurgery.

BACKGROUND: Head-mounted display (HMD) decreases the forced adjustments of position and eyes in endoscopic surgery. During transanal endoscopic microsurgery (TEM), these adjustments might even be greater because of the direct viewing technique. We investigated the feasibility of HMD in TEM. METHODS: Head-mounted display is a helmet with two built-in displays. The stereoscopic endoscope (with two separate lens systems) provides separate images at each display. During TEM, standard stereoscopic optic and HMD were alternated. RESULTS: Use of HMD was possible after construction of a special device. The helmet was comfortable to wear, and the peripheral view was adequate. The operator's position was upright and relaxed. The range and depth of vision seemed comparable with those of the standard stereoscopic optic. The quality of the displays in the helmet is limited. CONCLUSIONS: Head-mounted display is feasible in TEM. It enables a more relaxed position and view on the operative field. The quality of the display in the helmet requires improvement.

Local formalin instillation: an effective treatment for uncontrolled radiation-induced hemorrhagic proctitis.

AIM: The aim of this study was to evaluate the efficacy of local instillation of 4% formalin in the management of uncontrolled radiation-induced and ischemic hemorrhagic proctitis. PATIENTS AND METHODS: Eight patients were reviewed. Operation characteristics, morbidity and long-term results were analyzed. RESULTS: All patients were followed for a median of 18 months. In 5 patients the bleeding stopped after a single treatment and in 3 after a second one. During follow-up no recurrent rectal bleeding occurred, no further medical treatment was needed and in all patients the complaints had disappeared. CONCLUSION: Local instillation of 4% formalin is an effective treatment for uncontrolled radiation-induced and ischemic hemorrhagic proctitis.

Transanal endoscopic microsurgery for rectal cancer.

If curation is intended for rectal cancer, total mesorectal excision with autonomic nerve preservation (TME) is the gold standard. Transanal resection is tempting because of low mortality and morbidity rates. However, inferior tumour control, provoked by the limitations of the technique, resulted in its cautious application and use mainly for palliation. Transanal endoscopic microsurgery (TEM) is a minimal invasive technique for the local resection of rectal tumours. It is a one-port system, introduced transanally. An optical system with a 3D-view, 6-fold magnification and resolution as the human eye, together with the creation of a stabile pneumorectum, and specially designed instruments allow full-thickness excision under excellent view and a proper histological examination. The technique can also be applied for larger and more proximal tumours. Mortality, morbidity as well as incomplete excision rates are minimal. Local recurrence and survival rates seem comparable to TME in early rectal cancer. TEM is the method of choice when local resection of rectal cancer is indicated. Results justify a re-evaluation of the indications for the local excision of rectal cancer with a curative intent.

[Transanal endoscopic microsurgery: a good choice for local resection of rectal tumors]. / Transanale endoscopische microchirurgie: een goede mogelijkheid voor de lokale verwijdering van rectumtumoren.

OBJECTIVE: To investigate the feasibility of transanal endoscopic microsurgery (TEM), a minimal access technique for the local resection of rectal tumours. DESIGN: Prospective. SETTING: IJsselland Hospital, Capelle a/d IJssel, the Netherlands. PATIENTS AND METHOD: TEM was performed in all patients between January 1996 and December 1997 with a rectal adenoma that could not be removed endoscopically, or with a rectal carcinoma and poor general condition which allowed no transabdominal surgery. TEM involves air insufflation and endosurgical resection of the tumour under direct vision. RESULTS: In all 11 tumours within approximately 4 cm from the linea anorectalis conversion was necessary due to technical problems and 1 tumour could not be visualized because of a stenosis. In all 23 other tumours TEM was performed. Mean distance from the linea anorectalis was 6.9 cm (4-12), with a mean surface of the base of the tumour of 7.7 cm2 (1-30). Mean operating time was 76 minutes (10-180). In one tumour the defect could not be completely closed, and conversion was necessary. Postoperatively one suture dehiscence and one urinary tract infection occurred. None of the patients had functional disorders. Every specimen contained all bowel layers, and in all but one, the margins were free of tumour. In 13 tumours an adenoma was diagnosed and in 10, a carcinoma. In 2 patients with carcinoma additional resection was performed. Mean follow-up was 9 months (1-23), and concerned 21 tumours. No recurrence has been observed. CONCLUSION: TEM is a good method for the local resection of rectal tumours, when located more than 4 cm from the linea anorectalis. Radical resection, containing all bowel layers, is possible, and has, as it appears, a low recurrence rate.

A patient with gastric fundal varices and colonic varices due to splenic vein thrombosis.

We report a patient presenting with melena. Endoscopic examination showed gastric fundal varices as well as colonic varices. The latter is rarely encountered and is usually associated with portal hypertension. On angiography there appeared to be a splenic vein thrombosis which is only reported once earlier as a cause of colonic varices. A short review of the literature concerning colonic varices is added.

Bacteriology of selective decontamination: efficacy and rebound colonization.

In earlier studies concerning the use of selective decontamination (SD) we recognized some patients to have an incomplete or failed decontamination which had negative consequences for their outcome. We also experienced patients to have a rebound colonization with potentially pathogenic microorganisms (PPM) after the withdrawal of SD medication, thereby endangering the hospital environment as sources of possibly resistant microorganisms. In a prospective observational cohort-study, we have studied 135 patients on a surgical ICU in a University hospital. On admission 51% of all patients harboured PPM, of which 64% and 79% were eliminated form the oropharynx and gut, respectively. A total of 49 episodes of SD (32%) had to be defined as ineffective, partly due to late or inadequate administration of medication. Rebound colonization with nosocomial aerobic PPM was seen in 20 of 90 successfully decontaminated episodes, but there were no infections. Eighty-four of 123 surveillance cultures (68%) revealed a complete recolonization with flora in a composition not different from the pre-admission flora. Withdrawal of SD medication 5 days after extubation proved satisfactory because no infections ensued. Surveillance cultures are obligatory to determine whether SD is effective as one third of patients receiving SD experienced bacterial colonization with PPM and therefore had no benefit from this prophylaxis. In addition, these results indicate that an intact and functional colonization resistance develops in patients after cessation of effective SD medication, but only when physiological defence mechanisms are presumably restored. In the seven years of experience with SD, increasing antibiotic resistance has not been in the study hospital.

Decreased mortality rate and length of hospital stay in surgical intensive care unit patients with successful selective decontamination of the gut.

OBJECTIVE: Current studies concerning selective decontamination of the digestive tract have failed to demonstrate a decrease in the length of hospital stay and mortality rate, despite the finding of a significantly lower number of infections. To evaluate this issue in more detail, the relationship between the mortality rate and length of stay with respect to colonization and infections was studied within a group of patients receiving selective decontamination. Special attention was given to the efficacy of decontamination within each patient. The main question addressed was whether an effect on mortality rate was present, and if so, why this effect was not apparent until now. DESIGN: Prospective observational cohort study. SETTING: Surgical intensive care unit (ICU) in a university hospital. PATIENTS: Ninety-seven patients primarily admitted into the surgical ICU who received selective decontamination. Transferred patients were excluded. The majority of the surgeries were elective, and all patients completed the follow-up. INTERVENTIONS: All patients received polymyxin E, amphotericin B, and norfloxacin four times a day in a 2% solution of Orabase orally and enterally as suspensions of 200, 500, and 50 mg, respectively. Assessment of the efficacy of selective decontamination was done by identification of Gram-negative microorganisms in surveillance cultures from the oropharynx and rectum. Predicted mortality rates for each patient were calculated with a logistic regression formula. MEASUREMENTS AND MAIN RESULTS: A possible benefit of selective decontamination of the digestive tract would be expressed by lower actual mortality rates compared to predicted mortality rates. Since we expected the efficacy of decontamination to have an influence on infection and mortality rates, we evaluated these rates in terms of successful or unsuccessful decontamination. Most patients (n = 72) were successfully decontaminated. Actual death rates in these patients were significantly lower than the expected rates (as calculated by the Acute Physiology and Chronic Health Evaluation [APACHE] II scoring system) (18% vs. 40%, p = .006), whereas no difference was found in those patients with failed decontamination (n = 25, death rate 44%). The patients with unsuccessful selective decontamination had significantly longer hospital (52 vs. 34 days) and ICU lengths of stays (23 vs. 9 days; p = .002) and higher mortality rates (44% vs. 18%, p = .020) when compared with those patients who were successfully decontaminated. CONCLUSIONS: These results indicate that selective decontamination is beneficial in terms of mortality rate and length of stay in surgical patients only when successful decontamination has been achieved. The subgroup of patients for whom decontamination is not successful might be responsible for the obscurity in mortality effects of selective decontamination in studies until now. It is expected that identification and subsequent elimination of possible risk factors that cause a failure of selective decontamination can result in lower morbidity and mortality rates in critically ill, surgical patients admitted to the ICU.

Role of selective decontamination in surgery.

Aspects of selective decontamination as an antibiotic prophylaxis in general surgery are discussed with respect to the respiratory tract and wound infection. The high rate of nosocomial infection encountered in surgical patients, who experience up to 71 per cent of all such infection, is considered. The infection rate increases to 70-80 per cent after 1 week in the surgical intensive care unit, while the infection-related mortality rate rises to up to 60 per cent. The endogenous origin of nosocomial infection suggests the importance of maintaining colonization resistance to prevent colonization with Gram-negative micro-organisms, especially using selective decontamination which eliminates potentially pathogenic micro-organisms while leaving colonization resistance intact. Selective decontamination has proved effective in decreasing infection rates by 50-80 per cent, and is especially successful in respiratory tract infection. Possible adverse effects and future indications for selective decontamination are discussed.

Selective decontamination to reduce gram-negative colonisation and infections after oesophageal resection.

181 patients undergoing resection of the oesophagus for carcinoma were randomised to receive selective decontamination (test group) or conventional perioperative antibiotic prophylaxis (controls). 114 patients were finally included in the study: 12 of 56 test patients had 18 infections, whereas 32 of 58 controls acquired 51 infections. Colonisation with aerobic gram-negative microorganisms, and the number of postoperative respiratory tract infections were significantly lower in the test patients. The postoperative therapeutic use of antibiotics was significantly lower in the test group. No endogenous infections were caused by gram-negative bacilli in the test group. Selective decontamination reduces colonisation with gram-negative bacilli and postoperative infections after resection of the oesophagus.

Effects of selective decontamination on gram-negative colonisation, infections and development of bacterial resistance in esophageal resection.

Patients undergoing an esophageal resection because of carcinoma are at risk of developing postoperative respiratory tract infections. These patients were studied with respect to preceding colonisation with gram-negative bacilli and the effect of selective decontamination (SD) in decreasing this phenomenon, thereby reducing gram-negative infections. We randomised prospectively 114 patients into a test group receiving SD-medication (n = 56) and a control group receiving conventional prophylaxis. Postoperatively, all patients were admitted to the intensive care unit and mechanically ventilated. The preoperative administration of SD-medication resulted in adequate decontamination within 3-4 days in most patients, and SD could prevent gram-negative colonisation and infections effectively. Discontinuation of SD showed gram-negative (re-)colonisation, and resulted in 12 infections in 4 patients having late complications. This indicates that prolonged use in these patients might be beneficial. This new antibiotic prophylaxis proved effective, without causing an increase in bacterial resistance.

Operative treatment of median cervical cysts.

Median cervical cysts are congenital anomalies arising from remaining thyroglossal duct epithelium. A major problem in the surgical treatment of these cysts is the high frequency of recurrence. Embryonic considerations indicate an important causal role for the hyoid bone in these recurrences. We studied the relationship between operative techniques and the number of recurrences in 36 patients treated in our hospital. Fourteen patients sent from other hospitals had a recurrent fistula; in thirteen cases the hyoid bone was still in place. All patients who had the central part of the hyoid bone excised were cured. In 14 patients without adequate excisions of the hyoid bone we found four recurrences. To prevent recurrence a total excision of thyroglossal duct epithelium is necessary.