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.

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.

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.