Research transparency promotion by surgical journals publishing randomised controlled trials: a survey.

OBJECTIVE: To describe surgical journals' position statements on data-sharing policies (primary objective) and to describe key features of their research transparency promotion. METHODS: Only "SURGICAL" journals with an impact factor higher than 2 (Web of Science) were eligible for the study. They were included, if there were explicit instructions for clinical trial publication in the official instructions for authors (OIA) or if they had published randomised controlled trial (RCT) between 1 January 2016 and 31 December 2018. The primary outcome was the existence of a data-sharing policy included in the instructions for authors. Data-sharing policies were grouped into 3 categories, inclusion of data-sharing policy mandatory, optional, or not available. Details on research transparency promotion were also collected, namely the existence of a "prospective registration of clinical trials requirement policy", a conflict of interests (COIs) disclosure requirement, and a specific reference to reporting guidelines, such as CONSORT for RCT. RESULTS: Among the 87 surgical journals identified, 82 were included in the study: 67 (82%) had explicit instructions for RCT and the remaining 15 (18%) had published at least one RCT. The median impact factor was 2.98 [IQR = 2.48-3.77], and in 2016 and 2017, the journals published a median of 11.5 RCT [IQR = 5-20.75]. The OIA of four journals (5%) stated that the inclusion of a data-sharing statement was mandatory, optional in 45% (n = 37), and not included in 50% (n = 41). No association was found between journal characteristics and the existence of data-sharing policies (mandatory or optional). A "prospective registration of clinical trials requirement" was associated with International Committee of Medical Journal Editors (ICMJE) allusion or affiliation and higher impact factors. Journals with specific RCT instructions in their OIA and journals referenced on the ICMJE website more frequently mandated the use of CONSORT guidelines. CONCLUSION: Research transparency promotion is still limited in surgical journals. Standardisation of journal requirements according to ICMJE guidelines could be a first step forward for research transparency promotion in surgery.

Peri-operative pain and its consequences.

Recent advances in the management of peri-operative pain principally concern the recognition of the risk of developing pain chronicity. The best identified risk factors for pain chronicity are the presence of pain pre-operatively, pre-operative opioid use, and the intensity of post-operative pain. Ideal management of peri-operative pain in 2015 aims to optimize post-operative pain management, to detect the risk of pain chronicity begins pre-operatively with early detection of risk factors for chronicity. In terms of treatment, the systematic and generous use of morphine has shown its limitations, particularly due to reduced efficacy for movement-related pain. Meanwhile, opioid side effects can be very debilitating for the patient, leading to delay in post-operative rehabilitation, a dose-dependent hyperalgesic effect resulting in both acute and chronic pain, immune modulation that may have a deleterious impact on infectious complications or cancer [1], and, finally, some question of possible neurotoxicity. Therefore, modern analgesia depends on both intra-operative and post-operative morphine sparing. The goal at the present time is to obtain optimal analgesia that allows rapid rehabilitation without sequelae or chronicity through the use of drugs and/or techniques to avoid the need for opioid medications.

Effect of appendicectomy on colonic inflammation and neoplasia in experimental ulcerative colitis.

BACKGROUND: Ulcerative colitis (UC) promotes cancer, and can be ameliorated by early appendicectomy for appendicitis. The aim of the study was to explore the effect of appendicectomy on colitis and colonic neoplasia in an animal model of colitis and a cohort of patients with UC. METHODS: Five-week old IL10/Nox1(DKO) mice with nascent colitis and 8-week-old IL10/Nox1(DKO) mice with established colitis underwent appendicectomy (for experimental appendicitis or no appendicitis) or sham laparotomy. The severity and extent of colitis was assessed by histopathological examination, and a clinical disease activity score was given. From a cohort of consecutive patients with UC who underwent colectomy, the prevalence of appendicectomy and pathological findings were collected from two institutional databases. RESULTS: Appendicectomy for appendicitis ameliorated experimental colitis in the mice; the effect was more pronounced in the 5-week-old animals. Appendicectomy in the no-appendicitis group was associated with an increased rate of colonic high-grade dysplasia (HGD) or cancer compared with rates in sham and appendicitis groups (13 of 20 versus 0 of 20 and 0 of 20 respectively; P < 0·001). Fifteen of 232 patients who underwent colectomy for UC had previously had an appendicectomy, and nine of these had colonic cancer or HGD. Thirty (13·8 per cent) of 217 patients with the appendix in situ had colonic neoplastic lesions. Multivariable analysis showed that previous appendicectomy was associated with colorectal neoplasia (odds ratio 16·88, 95 per cent c.i. 3·32 to 112·69). CONCLUSION: Appendicectomy for experimental appendicitis ameliorated colitis. The risk of colorectal neoplasia appeared to increase following appendicectomy without induced appendicitis in a mouse model of colitis, and in patients with UC who had undergone appendicectomy. Surgical relevance Appendicectomy for appendicitis protects against UC. In this murine model of colitis, appendicectomy for experimental appendicitis protected against colitis, but appendicectomy without appendicitis promoted colorectal carcinogenesis. In patients with ulcerative colitis who underwent colectomy, absence of the appendix (proof of previous appendicectomy) in the resection specimen was independently associated with colorectal neoplasia. Although patients with UC and a history of appendicectomy represent a small subset, they may need closer monitoring for colorectal neoplasia.

French intensive training course in laparoscopic surgery (HUGOFirst) on live porcine models: Validation of a performance assessment scale and residents' satisfaction in a prospective study.

INTRODUCTION: Simulation as a method for practical teaching of surgical residents requires objective evaluation in order to measure the student's acquisition of knowledge and skills. The objectives of this article are to publish our evaluation and validation grids and also the measure of student satisfaction. METHOD: A teaching platform based on practical exercises with a porcine model was created in 2009 at seven French University Hospitals. Three times a year, 31 Diplôme d'Études Spécialisées Complémentaires (DESC) surgical residents underwent timed assessment of the performance of five surgical tasks: trocar insertion (trocars) testing the convergence of instruments (convergence), intra-corporeal knot tying (knots), running of the small intestine to find a lesion (exploration), and performance of a running suture closure of the peritoneum (closure). Two experts evaluated performances prospectively on grid score sheets specifically designed and validated for these exercises. We measured time, scores on a rating scale, and the interest and satisfaction of the residents. RESULTS: Data for 31 residents between May 2011 and March 2012 were analyzed. Rating scales were statistically validated and correlated (Kappa correlation coefficient K>0.69) for each task. The performance times of the most experienced residents decreased significantly for all tasks except for small bowel exploration (P=0.2). After four sessions, times were significantly improved with better quality (fewer errors and higher average scores [>88%]), regardless of the residents' experience. Of the participants, 92% were satisfied, 86% thought that the sessions improved their technical skills and 74% thought it had a favorable impact on their clinical practice. CONCLUSION: This study shows that the performance of surgical techniques can be improved through simulation, that HUFEG grids are valid, and that this teaching program is popular with surgical residents.

Leiomyosarcoma of the inferior vena cava.

BACKGROUND: Leiomyosarcoma (LMS) of the inferior vena cava (IVC) is a rare tumor with poor prognosis. Optimal treatment includes complete resection of the malignant lesion. METHODS: From 1997 to 2013, eight patients underwent surgery in our department for IVC LMS. LMS was considered to arise from the IVC if the tumor presented intraluminal development or if complete resection (R0) required removal of part of the IVC with an extraluminal mass. RESULTS: There were two grade 1 tumors (25%), four grade 2 (50%) and two grade 3 (25%). The median length of stay was 16 days and there were no peri-operative deaths. Median of follow-up was 56 months and mean overall survival was 120 months. Mean 3-year survival rate was 87.5%. Six patients (75%) developed a local recurrence. Four patients died from disease progression. Two patients underwent to surgery for recurrence. CONCLUSION: IVC LMS have a poor prognosis if surgical resection cannot be achieved. Long-term survival is related to an extensive surgery, in the event of recurrence, surgery should again be proposed and may be effective for controlling disease progression, possibly improving survival.

Intra-arterial yttrium-90 radioembolization combined with systemic chemotherapy is a promising method for downstaging unresectable huge intrahepatic cholangiocarcinoma to surgical treatment.

PURPOSE: To evaluate the downstaging efficacy of yttrium-90 radioembolization (Ytt-90)-associated with chemotherapy and the results of surgery for initially unresectable huge intrahepatic cholangiocarcinoma (ICC). METHODS: Between January 2008 and October 2013, unresectable ICC were treated with chemotherapy and Ytt-90. Patients with unique tumors localized to noncirrhotic livers and without extrahepatic metastasis were considered to be potentially resectable and were evaluated every 2 months for possible secondary resection. RESULTS: Forty-five patients were treated for unresectable ICCs; ten had potentially resectable tumors, and eight underwent surgery. Initial unresectability was due to the involvement of the hepatic veins or portal vein of the future liver remnant in seven and one cases, respectively. Preoperative treatment induced significant decreases in tumor volume (295 vs. 168 ml, p = 0.02) and allowed for R0 resection in all cases. Three patients (37.5 %) had Clavien-Dindo grade three or higher complications, including two postoperative deaths. The median follow-ups were 15.6 [range 4-40.7] months after medical treatment initiation and 7.2 [0.13-36.4] months after surgery. At the end of the study period, five patients were still alive, with one patient still alive 40 months after medical treatment initiation (36.4 months after surgery); two patients experienced recurrences. CONCLUSIONS: For initially unresectable huge ICCs, chemotherapy with Ytt-90 radioembolization is an effective downstaging method that allows for secondary resectability.

Inguinal lymphadenectomy for stage III melanoma: a comparative study of two surgical approaches at the onset of lymphoedema.

INTRODUCTION: When sentinel lymph node is positive for metastasis (exclusion for micro-metastasis) and in cases of palpable adenopathy, a lymphadenectomy should be performed. Many incisional surgical approach have been described in literature. We perform two type of incision (vertical with skin excision and transversal) for inguinal lymphadenectomy. The aim of this study was to compare post-operative morbidity between these two approach in cases of Stage III Melanoma. We analysed chronic lymphoedeme, skin necrosis, wound dehiscence, wound infection and seroma rates between the two techniques. METHODS: From April 2000 to February 2012 fifty-three patients underwent to inguinal lymphadenectomy for Stage III melanoma at CHU of Rennes. Patients were stratified in 2 groups according to the surgical approach, group 1 with a vertical incision with skin excision and group 2 with a transverse incision. RESULTS: Chronic lymphoedema rate for group 1 was 37.04% and for group 2 rate was 26.92%, this complication was lower un group 2 but no significant difference was observed (p = 0.558). Skin necrosis (p = 0.235), wound dehiscence (p = 1.000), wound infection (p = 0.236) and seroma (p = 0.757) were not significantly different. Two cases of skin necrosis were observed in group 2 (7.69%) and none in group 1. CONCLUSION: We do not found significant difference for chronic lymphoedema between these two approach. However, we had less lymphoedema with the transversal technique which has the advantage to reduce the skin suffering when external iliac lymphadenectomy dissection is necessary in addition to the inguinal lymphadenectomy.

Biliary cirrhosis and sepsis are two risk factors of failure after surgical repair of major bile duct injury post-laparoscopic cholecystectomy.

BACKGROUND: Major bile duct injury (MBDI) remains frequent after laparoscopic cholecystectomy (LC) reaching 0.3 to 0.6 % and is associated with a significant mortality rate. The aim of this study was to retrospectively analyze the factors likely to influence the long-term results of surgical repair for MBDI occurring after LC. METHODS: Medical records of patients referred to our referral center from January 1992 to January 2010 for management of bile duct injury following LC were retrospectively analyzed, and patients with MBDI were identified. Clinicopathological factors likely to influence long-term results after surgical repair were assessed by univariate and multivariable analysis. RESULTS: During the study period, 38 patients were treated for MBDI. These 38 patients underwent Roux-en-Y hepaticojejunostomy (HJ) or HJ revision in 25 (66 %) and 13 (34 %) cases, respectively. The median follow-up period was 93 (26-204) months. A Clavien-Dindo post-operative morbidity class >3 occurred in 10 (26 %) cases and was independently associated with a surgical repair performed during a sepsis period (OR = 102.5; IC 95 % [7.12; 11,352], p < 0.007). Long-term results showed that biliary strictures occurred in 5 (13 %) cases and were associated with sepsis (p < 0.006), liver cirrhosis (p < 0.002) and post-operative complications (p < 0.012). Multivariate analysis revealed that only liver cirrhosis remained predictive of stricture (OR = 26.4, 95 % CI [2; 1,018], p < 0.026). CONCLUSION: When MBDI occurs following LC, HJ seems to be the optimal treatment but should not be performed during a sepsis period. Long-term results are significantly altered by the presence of a biliary cirrhosis at time of repair.

Boosted selective internal radiation therapy with 90Y-loaded glass microspheres (B-SIRT) for hepatocellular carcinoma patients: a new personalized promising concept.

PURPOSE: To evaluate the impact of dosimetry based on MAA SPECT/CT for the prediction of response, toxicity and survival, and for treatment planning in patients with hepatocellular carcinoma (HCC) treated with (90)Y-loaded glass microspheres (TheraSphere®). METHODS: TheraSphere® was administered to 71 patients with inoperable HCC. MAA SPECT/CT quantitative analysis was used for the calculation of the tumour dose (TD), healthy injected liver dose (HILD), and total injected liver dose. Response was evaluated at 3 months using EASL criteria. Time to progression (TTP) and overall survival (OS) were evaluated using the Kaplan-Meier method. Factors potentially associated with liver toxicity were combined to construct a liver toxicity score (LTS). RESULTS: The response rate was 78.8%. Median TD were 342 Gy for responding lesions and 191 Gy for nonresponding lesions (p < 0.001). With a threshold TD of 205 Gy, MAA SPECT/CT predicted response with a sensitivity of 100% and overall accuracy of 90%. Based on TD and HILD, 17 patients underwent treatment intensification resulting in a good response rate (76.4%), without increased grade III liver toxicity. The median TTP and OS were 5.5 months (2-9.5 months) and 11.5 months (2-31 months), respectively, in patients with TD <205 Gy and 13 months (10-16 months) and 23.2 months (17.5-28.5 months), respectively, in those with TD >205 Gy (p = 0.0015 and not significant). Among patients with portal vein thrombosis (PVT) (n = 33), the median TTP and OS were 4.5 months (2-7 months) and 5 months (2-8 months), respectively, in patients with TD <205 Gy and 10 months (6-15.2 months) and 21.5 months (12-28.5 months), respectively, in those with TD >205 Gy (p = 0.039 and 0.005). The median OS was 24.5 months (18-28.5 months) in PVT patients with TD >205 Gy and good PVT targeting on MAA SPECT/CT. The LTS was able to detect severe liver toxicity (n = 6) with a sensitivity of 83% and overall accuracy of 97%. CONCLUSION: Dosimetry based on MAA SPECT/CT was able to accurately predict response and survival in patients treated with glass microspheres. This method can be used to adapt the injected activity without increasing liver toxicity, thus defining a new concept of boosted selective internal radiation therapy (B-SIRT). This new concept and LTS enable fully personalized treatment planning with glass microspheres to be achieved.

Surgical treatment of esophageal perforations: the importance of a primary repair.

PURPOSE: The aim of the current study was to evaluate the outcome after primary repair in comparison to other surgical treatments and the advantage of reinforcing the sutures with an absorbable polyglactin 910 prosthesis. METHODS: All esophageal perforations surgically managed in this institution from January 1985 through April 2009 (n = 40) were retrospectively analyzed. Patients that underwent surgery with primary sutures (group A, n = 24) were compared with patients that received other surgical procedures (group B, n = 16). The time to initiate treatment (within or after the first 24 h) and if the suture was reinforced with a polyglactin 910 mesh were also analyzed in group A patients. RESULTS: The outcome was more favorable in group A than group B in terms of time in the intensive care unit (p = 0.005), and rate of reoperation (p = 0.005). There was no difference in the outcome after the primary suture with or without mesh reinforcement, although the rate of fistulization was lower in patients with a mesh (17 vs. 50 %, p = 0.19). CONCLUSIONS: Primary repair has a better outcome than other surgical treatment, even when performed more than 24 h after symptom onset, but not later than 48 h. Reinforcing the sutures with an absorbable polyglactin 910 mesh therefore seems to improve the outcome.

Conservative surgical management of Boerhaave's syndrome: experience of two tertiary referral centers.

BACKGROUND: Surgery is generally proposed for Boerhaave's syndrome, spontaneous rupture of the esophagus. But diagnosis can be difficult, delaying appropriate management. The purpose of the present study was to evaluate outcome of conservative surgery for primary or T-tube repair performed in two tertiary referral centers. METHODS: From June 1985 to November 2010, among 53 patients presenting with Boerhaave's syndrome treated surgically, 39 underwent a conservative procedure. These patients were retrospectively divided into two groups by type of repair: primary suture (group 1, n = 25) or suture on a T-tube (group 2, n = 14). Patients in group 1 were further stratified into two subgroups depending on whether the primary suture was made with reinforcement (subgroup rS) or not (subgroup S). RESULTS: Length of stays in hospital and intensive care were shorter in patients in group 1 (p = 0.037), but after a shorter delay before therapeutic management (p = 0.003) compared with group 2. For the other variables studied, outcome was more favorable in group 1, but the differences were not significant. Comparing subgroups rS and S showed that the rate of persistent leakage was significantly lower after reinforced suture (p = 0.021). CONCLUSIONS: These findings from the largest reported cohort of Boerhaave's syndrome patients undergoing conservative surgery showed that primary and T-tube repair provide at least equivalent results. Reinforced sutures appear to provide better outcomes by reducing postoperative leakage.

Treatment of recurrent intrahepatic cholangiocarcinoma.

BACKGROUND: The aims of this study were to evaluate risk factors for recurrence following hepatectomy with curative intent for intrahepatic cholangiocarcinoma (ICC), and predictors of survival after intrahepatic recurrence. METHODS: All patients with ICC who underwent liver resection between January 1997 and August 2011 in a single centre were analysed retrospectively. Clinicopathological factors likely to influence recurrence and postrecurrence survival were assessed by univariable and multivariable analysis. RESULTS: A total of 87 patients were analysed. R0 resection was achieved in 65 patients (75 per cent). Eighty-three patients survived more than 1 month after resection. Median survival was 33 months, with 1-, 3- and 5-year actuarial survival rates of 79, 47 and 31 per cent respectively. Recurrence occurred in 45 (54 per cent) of the 83 patients, most frequently in the liver (25 patients). Satellite nodules (odds ratio (OR) 8·17, 95 per cent confidence interval 1·38 to 48·53; P = 0·021), hilar lymph node metastases (OR 5·24, 1·07 to 25·75; P = 0·041) and perineural invasion (OR 9·68, 1·07 to 87·54; P = 0·043) were identified as independent risk factors for recurrence. Repeat hepatectomy (P = 0·003) and intra-arterial yttrium-90 radiotherapy (P = 0·048) were associated with longer survival after intrahepatic recurrence. CONCLUSION: Satellite nodules, hilar lymph node metastases and perineural invasion are risk factors for recurrence following resection with curative intent for ICC. Repeat hepatectomy and labelled yttrium-90 radiotherapy may improve survival after intrahepatic recurrence.

Esophageal perforations.

The incidence of esophageal perforation (EP) has risen with the increasing use of endoscopic procedures, which are currently the most frequent causes of EP. Despite decades of clinical experience, innovations in surgical technique and advances in intensive care management, EP still represents a diagnostic and therapeutic challenge. EP is a devastating event and mortality hovers close to 20%. Ambiguous presentations leading to misdiagnosis and delayed treatment and the difficulties in management are responsible for the high morbidity and mortality rates. A high variety of treatment options are available ranging from observational medical therapy to radical esophagectomy. The potential role of interventional endoscopy and the use of stents for the treatment of EP seem interesting but remain to be evaluated. Surgical primary repair, with or without reinforcement, is the preferred approach in patients with EP. Prognosis is mainly determined by the cause, the location of the injury and the delay between perforation and initiation of therapy.