Quality of life in patients with a perineal hernia

Introduction: Patients who develop a perineal hernia after abdominoperineal resection may experience discomfort during daily activities and urogenital dysfunction, but the impact on quality of life has never been formally assessed. Materials and methods: Patients who underwent abdominoperineal resection for rectal cancer between 2014 and 2022 in two prospective multicenter trials were included. Primary outcome was defined as median overall scores or scores on functional and symptom scales of the following quality of life questionnaires: 5-level version of the 5-dimensional EuroQol, Short Form-36, and European Organization for Research and Treatment of Cancer QoL Questionnaire Colorectal cancer 29 and 30, Urogenital Distress Inventory-6, Incontinence Impact Questionnaire-7. Results: Questionnaires were available in 27 patients with a perineal hernia and 62 patients without a perineal hernia. The 5-dimensional EuroQol score was significantly lower in patients with a perineal hernia (83 vs 87, p = 0.048), which implies a reduced level of functioning. The median scores of pain-specific domains were significantly worse in patients with a perineal hernia as measured by the SF-36 (78 vs. 90, p = 0.006), the EORTC-CR29 (17 vs. 11, p=&lt;0.001) and EORTC-C30 (17 vs. 0, p = 0.019). Also, significantly worse physical (73 vs. 100, p = 0.049) and emotional (83 vs. 100, p = 0.048) functioning based on EORTC-C30 was observed among those patients. Minimally important differences were found for role, physical and social functioning of the SF-36 and EORTC-C30. The urological function did not differ between the groups. Conclusion: A symptomatic perineal hernia can significantly worsen quality of life on several domains, indicating the severity of this complication.</p

Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial

Background: The peritoneum is the second most common site of recurrence in colorectal cancer. Early detection of peritoneal carcinomatosis (PC) by imaging is difficult. Patients eventually presenting with clinically apparent PC have a poor prognosis. Median survival is only about five months if untreated and the benefit of palliative systemic chemotherapy is limited. Only a quarter of patients are eligible for curative treatment, consisting of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CR/HIPEC). However, the effectiveness depends highly on the extent of disease and the treatment is associated with a considerable complication rate. Methods/Design: The aim of this study is to determine the effectiveness of adjuvant HIPEC in preventing the development of PC in patients with colon cancer at high risk of peritoneal recurrence. This study will be performed in the nine Dutch HIPEC centres, starting in April 2015. Eligible for inclusion are patients who underwent curative resection for T4 or intra-abdominally perforated cM0 stage colon cancer. After resection of the primary tumour, 176 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously or shortly after the primary resection. Oxaliplatin will be used as chemotherapeutic agent, for 30 min at 42-43 °C. Just before HIPEC, 5-fluorouracil and leucovorin will be administered intravenously. Primary endpoint is peritoneal disease-free survival at 18 months. Diagnostic laparoscopy will be performed routinely after 18 months postoperatively in both arms of the study in patients without evidence of disease based on routine follow-up using CT imaging and CEA. Discussion: Adjuvant HIPEC is assumed to reduce the expected 25 % absolute risk of PC in patients with T4 or perforated colon cancer to a risk of 10 %. This reduction is likely to translate into a prolonged overall survival. Trial registration number: NCT02231086 (Clinicaltrials.gov)

Insurance Firms in Process of Industrialization

Background: Primary perineal wound closure after conventional abdominoperineal resection (cAPR) for rectal cancer has been the standard of care for many years. Since the introduction of neo-adjuvant radiotherapy and the extralevator APR (eAPR), oncological outcome has been improved, but at the cost of increased rates of perineal wound healing problems and perineal hernia. This has progressively increased the use of biological meshes, although not supported by sufficient evidence. The aim of this study is to determine the effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo) radiotherapy compared to primary perineal wound closure. Methods/Design: In this multicentre randomized controlled trial, patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo) radiotherapy will be considered eligible. Exclusion criteria are prior radiotherapy, sacral resection above S4/S5, allergy to pig products or polysorbate, collagen disorders, and severe systemic diseases affecting wound healing, except for diabetes. After informed consent, 104 patients will be randomized between standard care using primary wound closure of the perineum and the experimental arm consisting of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm. Patients will be followed for one year after the intervention and outcome assessors and patients will be blinded for the study treatment. The primary endpoint is the percentage of uncomplicated perineal wound healing, defined as a Southampton wound score of less than II on day 30. Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs. Discussion: The BIOPEX-study is the first randomized controlled multicentre study to determine the additive value of using a biological mesh for perineal wound closure after eAPR with neo-adjuvant radiotherapy compared to primary perineal wound closure with regard to perineal wound healing and the occurrence of perineal hernia

Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with colon cancer at high risk of peritoneal carcinomatosis; the COLOPEC randomized multicentre trial

Background: The peritoneum is the second most common site of recurrence in colorectal cancer. Early detection of peritoneal carcinomatosis (PC) by imaging is difficult. Patients eventually presenting with clinically apparent PC have a poor prognosis. Median survival is only about five months if untreated and the benefit of palliative systemic chemotherapy is limited. Only a quarter of patients are eligible for curative treatment, consisting of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CR/HIPEC). However, the effectiveness depends highly on the extent of disease and the treatment is associated with a considerable complication rate. These clinical problems underline the need for effective adjuvant therapy in high-risk patients to minimize the risk of outgrowth of peritoneal micro metastases. Adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) seems to be suitable for this purpose. Without the need for cytoreductive surgery, adjuvant HIPEC can be performed with a low complication rate and short hospital stay. Methods/Design: The aim of this study is to determine the effectiveness of adjuvant HIPEC in preventing the development of PC in patients with colon cancer at high risk of peritoneal recurrence. This study will be performed in the nine Dutch HIPEC centres, starting in April 2015. Eligible for inclusion are patients who underwent curative resection for T4 or intra-abdominally perforated cM0 stage colon cancer. After resection of the primary tumour, 176 patients will be randomized to adjuvant HIPEC followed by routine adjuvant systemic chemotherapy in the experimental arm, or to systemic chemotherapy only in the control arm. Adjuvant HIPEC will be performed simultaneously or shortly after the primary resection. Oxaliplatin will be used as chemotherapeutic agent, for 30 min at 42-43 degrees C. Just before HIPEC, 5-fluorouracil and leucovorin will be administered intravenously. Primary endpoint is peritoneal disease-free survival at 18 months. Diagnostic laparoscopy will be performed routinely after 18 months postoperatively in both arms of the study in patients without evidence of disease based on routine follow-up using CT imaging and CEA. Discussion: Adjuvant HIPEC is assumed to reduce the expected 25 % absolute risk of PC in patients with T4 or perforated colon cancer to a risk of 10 %. This reduction is likely to translate into a prolonged overall survival

Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study)

BACKGROUND: Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose, and with the advantage of not having a donor site scar. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer. METHODS: Patients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function. DISCUSSION: The uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place. TRIAL REGISTRATION: The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019

Perineal wound healing after abdominoperineal resection for rectal cancer: a systematic review and meta-analysis

Impaired perineal wound healing has become a significant clinical problem after abdominoperineal resection for rectal cancer. The increased use of neoadjuvant radiotherapy and wider excisions might have contributed to this problem. The primary aim of this systematic review with meta-analysis was to determine the impact of radiotherapy and an extralevator approach on perineal wound healing after abdominoperineal resection for rectal cancer. In March 2014, electronic databases were searched. Studies describing any outcome measure on perineal wound healing after abdominoperineal resection for rectal cancer were included. The primary end point was overall perineal wound problems within 30 days after conventional or extralevator abdominoperineal resection with or without neoadjuvant radiotherapy. Secondary end points were primary wound healing, perineal hernia rate, and the effect of biological mesh closure on perineal wound problems. A total of 32 studies were included. The pooled percentage of perineal wound problems after primary perineal wound closure in patients who did not undergo neoadjuvant radiotherapy was 15.3% (95% CI, 12.1-19.2) after conventional abdominoperineal resection and 14.8% (95% CI, 9.5-22.4) after extralevator abdominoperineal resection. After neoadjuvant radiotherapy, perineal wound problems occurred in 30.2% (95% CI, 19.2-44.0) after conventional abdominoperineal resection and in 37.6% (95% CI, 18.6-61.4) after extralevator abdominoperineal resection. Radiotherapy significantly increased perineal wound problems after abdominoperineal resection (OR, 2.22; 95% CI, 1.45-3.40; p < 0.001). After biological mesh closure of the pelvic floor following extralevator abdominoperineal resection with neoadjuvant radiotherapy, the percentage of perineal wound problems was 7.3% (95% CI, 1.5-29.3). Heterogeneity was high for some analyses. Neoadjuvant radiotherapy significantly increases perineal wound problems after abdominoperineal resection for rectal cancer, whereas the extralevator approach seems not to be of significant importanc