Protocol to develop a core outcome set in incisional hernia surgery: the HarMoNY Project.

INTRODUCTION: Incisional hernia has an incidence of up to 20% following laparotomy and is associated with significant morbidity and impairment of quality of life. A variety of surgical strategies including techniques and mesh types are available to manage patients with incisional hernia. Previous works have reported significant heterogeneity in outcome reporting for abdominal wall herniae, including ventral and inguinal hernia. This is coupled with under-reporting of important clinical and patient-reported outcomes. The lack of standardisation in outcome reporting contributes to reporting bias, hinders evidence synthesis and adequate data comparison between studies. This project aims to develop a core outcome set (COS) of clinically important, patient-oriented outcomes to be used to guide reporting of future research in incisional hernia. METHODS: This project has been designed as an international, multicentre, mixed-methods project. Phase I will be a systematic review of current literature to examine the current clinical and patient-reported outcomes for incisional hernia and abdominal wall reconstruction. Phase II will identify the outcomes of importance to all key stakeholders through in depth qualitative interviews. Phase III will achieve consensus on outcomes of most importance and for inclusion into a COS through a Delphi process. Phase IV will achieve consensus on the outcomes that should be included in a final COS. ETHICS AND DISSEMINATION: The adoption of this COS into clinical and academic practice will be endorsed by the American, British and European Hernia Societies. Its utilisation in future clinical research will enable appropriate data synthesis and comparison and will enable better clinical interpretation and application of the current evidence base. This study has been registered with the Core Outcome Measures in Effectiveness Trials initiative. PROSPERO REGISTRATION NUMBER: CRD42018090084.

Oncological outcome of local vs radical resection of low-risk pT1 rectal cancer.

HYPOTHESIS: Despite the noninclusion of locally draining lymph nodes, limited resection of low-risk pT1 rectal cancer can achieve an adequate oncological outcome with lower morbidity and mortality compared with radical resection. DESIGN: Based on the data of a prospective multicenter observational study performed from January 1, 2000, through December 31, 2001, patients with low-risk pT1 rectal cancer underwent analysis with regard to the early postoperative outcome and the oncological long-term results achieved after limited vs radical resection with curative intent. SETTING: Two hundred eighty-two hospitals of all categories. PATIENTS: Four hundred seventy-nine patients with low-risk pT1 rectal cancer treated for cure. INTERVENTIONS: Eighty-five patients (17.7%) underwent limited excision using a conventional transanal approach and 35 (7.3%) using transanal endoscopic microsurgery. The remaining 359 (74.9%) underwent radical resection. MAIN OUTCOME MEASURES: Postoperative morbidity and mortality, local recurrence rate, and tumor-free and overall survival. RESULTS: In comparison with radical resection, limited resection was associated with fewer general (25.1% vs 7.5%; P<.001) and specific (22.8% vs 9.2%; P<.001) postoperative complications. After a mean follow-up of 44 months, patients who underwent limited resection had a significantly higher 5-year local tumor recurrence rate than did those who underwent radical resection (6.0% vs 2.0%; P = .049), but tumor-free survival did not differ. CONCLUSION: Limited resection of pT1 low-risk rectal cancer can result in an oncologically acceptable outcome but must nevertheless be considered an oncological compromise compared with radical resection.

Surgical strategies in the laparoscopic therapy of cholecystolithiasis and common duct stones.

BACKGROUND: The purpose of the present study was to examine the current approach and different strategies adopted for laparoscopic cholecystectomy in Germany. METHODS: A retrospective survey was conducted at 859 (n = 1200; 67.6%) hospitals in Germany. Data from 123 090 patients who had undergone cholecystectomy were analysed. RESULTS: 71.9% of the operations were finished laparoscopically (n = 88 537) whereas 22.5% were carried out using the open technique. Conversion to open surgery was required in 7.1% of the laparoscopically started operations. When common bile duct stones were diagnosed preoperatively, 74.4% of the participants favoured the primary endoscopic extraction, following laparoscopic cholecystectomy. In cases of intraoperative diagnoses, laparoscopic cholecystectomy was finished and postoperative primary endoscopic extraction was carried out in more than half of the hospitals (58.4%). Sixteen per cent converted to an open operation with simultaneous exploration of the common duct. Laparoscopic desobstruction of the common bile duct was extremely rare (4.4%). Compared with open cholecystectomy, the results show a lower incidence of postoperative reinterventions (0.9 vs 1.8%) and fatal outcomes (0.04 vs 0.53%) for laparoscopic cholecystectomy. In contrast, common bile duct injuries were more frequent in the laparoscopic cholecystectomy group (0.32 vs 0.12%). The median duration of hospitalization was 6.1 days (range: 2.8-12) in the laparoscopic cholecystectomy group compared with 10.4 days (range: 3-28) in the open cholecystectomy group. CONCLUSIONS: Laparoscopic cholecystectomy is the standard procedure for the treatment of uncomplicated gallstone disease. There are reasonable differences between the hospitals in type of cholecystectomy for acute cholecystitis, management of common duct stones and intraoperative diagnostics in laparoscopic cholecystectomy, even after adjustment for differences in patient comorbidities.