Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial.

Cancer and/or major surgery are two factors that predispose to post-operative thrombosis. The annual incidence of venous thromboembolic disease (VTED) in cancer patients was estimated at 0.5%-20%. Surgery increases the risk of VTED by 29% in the absence of thromboprophylaxis. Enoxaparin is a low molecular weight heparin that is safe and effective. Branded Enoxaparin and biosimilar Enoxaparin are two enoxaparin treatments. This study aimed to compare Branded Enoxaparin with biosimilar Enoxaparin in patients operated on for digestive cancer regarding the prevention of postoperative thrombosis event, to compare the tolerance of the two treatments and to identify independent predictive factors of thromboembolic incident. A randomized controlled trial conducted in a single-centre, surgical department B of Charles Nicolle Hospital, over a 5-year period from October 12th, 2015, to July 08th, 2020. We included all patients over 18 who had cancer of the digestive tract newly diagnosed, operable and whatever its nature, site, or stage, operated on in emergency or elective surgery. The primary endpoint was any asymptomatic thromboembolic event, demonstrated by systematic US Doppler of the lower limbs on postoperative day 7 to day 10. The sonographer was unaware of the prescribed treatment (Branded Enoxaparin [BE] or biosimilar Enoxaparin [BSE]). Of one hundred sixty-eight enrolled patients, six patients (4.1%) had subclinical venous thrombosis. Among those who had subclinical thrombosis, four patients (5.6%) were in the Branded Enoxaparin group and two patients (2.7%) in the Biosimilar Enoxaparin group without statistically significant difference (p = 0.435). Analysis of the difference in means using Student's t test demonstrated the equivalence of the two treatments. Our study allowed us to conclude that there was no statistically significant difference between Branded Enoxaparin and Biosimilar Enoxaparin regarding the occurrence of thromboembolic accidents postoperatively. BE and BSE are equivalent. Trial registration. Trial registration: The trial was registered on CLINICALTRIALS.GOV under the number NCT02444572.

Predictive factor of recurrence after curative resection for stage I-II colon cancer.

BACKGROUND: Colon cancer has become a common malignant neoplasm in Tunisia. Patients with negative lymph node have a 5 years recurrence rate of 21.1%. Studies reporting the prognostic factors of recurrence for patients with stage I-II colon cancer are limited. AIM: This study aimed to determine factors predicting recurrence for patients with stage I-II colon cancer after curative resection. METHODS: This was a retrospective cohort study. Were included patients who underwent curative surgery for stage I or II colon cancer. Enrolled variables were subdivided into: Pre-operative, Intraoperative and Post-operative variables. Main outcome measures were local recurrence and distant metastasis detected during follow-up. RESULTS: Eighteen men and 17 women with median age of 61 years, ranging from 33 to 89, were enrolled in this study. Twenty-eight patients out of 35 were classified T3 and T4 colon cancer. The mean number of lymph nodes harvested was 16.23 (median= 17; range: 4-44). Ten patients (28%) had colloid component in the tumor. At a median follow-up of 23 months (range: 6-56 months), recurrence was observed in five cases (14%). Variables associated to recurrence were Carcinoembryonic antigen level (p= 0.03), serum albumin level (p=0.029) and the presence of colloid component (0.02). Multivariate logistic regression retained colloid component as the only predictive factor of recurrence (OR=1.2, 95%CI [1.019-1.412], p=0.028). CONCLUSIONS: This study showed that the percentage of mucinous component equal or greater than 25% was the only predictive factor of recurrence for curatively resected, stages I and II, colon cancer.

Self-directed learning digital tool versus tutorials under the guidance of an educator: Randomized trial.

INTRODUCTION: Self-directed learning digital tool aims to enable students to acquire skills in an autonomous way. The aim of this work was to compare a self-directed learning digital tool in non-traumatic abdominal emergencies with tutorials under the guidance of the educator in two parallel groups of second-year of second-cycle of medical students selected by means of a draw. METHODS: We performed a controlled trial with draw comparing the self-directed learning digital tool and tutorials under the guidance of a teacher. Second-year of second-cycle medical students under training in general surgery from February, 20, 2017 to May, 7, 017 were included. Main judgment criterion was the assessment of the skills gained by students by means of the total score got at the objective structured clinical examination. We have carried out a descriptive survey, kappa statistics to study agreement between examiners, followed by an ANOVA test. We have compared the total score for the self-directed learning digital tool group with the total score of the tutorials group by using the « t ¼ test of Student and the « U ¼ test of Mann-Whitney. We performed a ROC curve for the total score. We have also achieved a satisfaction survey. RESULTS: Twenty seven students were enrolled: 14 in the « self-directed learning digital tool ¼ group and 13 in the « tutorials ¼ group. The average total score for all the students was 230 ± 52 points [extremes: 71,5 - 318,5]. There was no difference between examiners (kappa test and ANOVA test). The univariate analysis showed a total score and a score by examiner higher in a statistically significant way for the « self-directed learning digital teaching tool ¼ group. The ROC curve allowed us to conclude that the self-directed learning digital tool had an important discriminating power[an area under the curve equal to 0,791, (CI95%: 0,616-0,966) with p=0,010]. CONCLUSION: Self-directed learning digital tool has allowed second-year of second-cycle medical students to acquire skills in matters of interpretation of medical imaging in non-traumatic abdominal emergency with a higher rate compared with tutorials.

Endogenous hyperinsulinism: diagnostic and therapeutic difficulties.

Endogenous hyperinsulinism is an abnormal clinical condition that involves excessive insulin secretion, related in 55% of cases to insulinoma. Other causes are possible such as islet cell hyperplasia, nesidioblastosis or antibodies to insulin or to the insulin receptor. Differentiation between these diseases may be difficult despite the use of several morphological examinations. We report six patients operated on for endogenous hyperinsulinism from 1st January 2000 to 31st December 2015. Endogenous hyperinsulinism was caused by insulinoma in three cases, endocrine cells hyperplasia in two cases and no pathological lesions were found in the last case. All patients typically presented with adrenergic and neuroglycopenic symptoms with a low blood glucose level concomitant with high insulin and C-peptide levels. Computed tomography showed insulinoma in one case out of two. MRI was carried out four times and succeeded to locate the lesion in the two cases of insulinoma. Endoscopic ultrasound showed one insulinoma and provided false positive findings three times out of four. Intra operative ultrasound succeeded to localize the insulinoma in two cases but was false positive in two cases. Procedures were one duodenopancreatectomy, two left splenopancreatectomy and two enucleations. For the sixth case, no lesion was radiologically objectified. Hence, a left blind pancreatectomy was practised but the pathological examination showed normal pancreatic tissue. Our work showed that even if morphological examinations are suggestive of insulinoma, other causes of endogenous hyperinsulinism must be considered and therefore invasive explorations should be carried out.

Management of perforated duodenal peptic ulcer treated by suture.

BACKGROUND: Laparoscopic surgery has become the gold standard for many procedures owing to its advantages such as a shorter post-operative stay, a faster recovery and less postoperative pain. However, choosing laparoscopic approach in an emergency situationsuch as in the management of a perforated duodenal peptic ulcer is still debated because of the absence of significant benefits. This study aimed to assess the management of perforated duodenal peptic ulcer treated by suture. METHODS: It's a retrospective study enrolling 81 patients operated on for duodenal perforated peptic ulcer between June 1st, 2012 and December 31st, 2016 who underwent surgery in the surgical department B of Charles Nicolle's Hospital. RESULTS: Our retrospective study showed that laparoscopic approach had shorter post-operative duration (3 [1-5] versus 4 [1-16] days, respectively, p< 0.001), shorter mortality rate (3% versus 19%, p=0.032) and more uneventful post-operative course (97% versus 74%, p=0.004) comparing to the open approach. Patients who were not admitted in the intensive care unit during the first 48 hours had 9.901 more chance to be operated by laparoscopic approach. Patients who were operated on by a senior had 3.240 times more chance to be operated by laparoscopic approach. There was no predictive variable for conversion. Mortality rate was 11%. Age was the only predictive independent factor of mortality with a cut-off point of 47 years. CONCLUSIONS: Laparoscopic approach is routinely practised in the perforated duodenal ulcer. In our study, we showed that laparoscopic approach had less post-operative complications, a lower rate of mortality and a shorter post-operative duration comparing to the open approach. The main limitation of our study was non-randomization and lack of laparoscopic expertise. The decision for either open or laparoscopic approach was then dependent on senior surgeon's availability.

Predictive factors for major amputation of lower limb in diabetic foot: about 430 patients.

BACKGROUND: Major amputation of the lower limb is defined by a leg or thigh amputation. The aim of our work was identifying predictive factors for lower limb major amputation in patients with diabetes admitted on for foot lesions through using an administrative data base. METHODS: It was a retrospective study ranging from June 1st, 2008 to December 31st, 2011, which included all the patients admitted on for an infected diabetic foot to the surgery unit B of Charles Nicolle hospital in Tunis. The main judgement criterion was the major amputation of the lower limb. We have done a descriptive and a comparative study, with univariate and multivariate analysis. RESULTS: We have enrolled 319 men and 111 women. The average age was 60.5 ± 12 years. Ninety five patients (24%) had a major amputation. Former inpatient, patient readmitted within one month post-operatively, stay in intensive care, admission in intensive care within 48hours after admission, age ≥ 65 years, presence of kidney problem, preoperative stay and length of intervention were identified as predictive factors of major amputation in the univariate analysis. Age was the only independent variable predictive for major amputation which appeared from the multivariate analysis (p=0.004).  The age cut-off ≥ 65 years has a specificity of 69 % and a sensitivity of 47% [p=0.004, OR=1.971, IC 95% : 1.239-3.132]. CONCLUSIONS: Age was the only independent predictive factor for major amputation of the lower limb in the diabetic foot with a threshold value higher or equal to 65 years. Patients aged more than 65 had 1.9 time more risk to undergo major amputation of the lower limb.

Atypical form of peritoneal tuberculosis.

It was a 48-year-old woman with a right flank mass. On examination there was a hard and painful mass of the right side, centered by a fistula orifice with a diameter of 5 mm. Abdominal computed tomography showed an intraperitoneal tissue structure in relation to the parietal peritoneum in the left hypochondria. A scanno-guided biopsy was performed. Pathological examination revealed non-specific inflammatory lesions. The evolution was marked by the appearance of a purulent fistula in the puncture site. A biopsy of the margins of the fistulous orifice of the left hypochondria was performed. Pathological examination found a granular infiltrate with caseous necrosis confirming the diagnosis of tuberculosis. The patient was put under anti-tuberculosis treatment with a good clinical and radiological evolution.

Morbidity and mortality of infected diabetic foot managed in general surgical department.

BACKGROUND: Foot ulcers are diabetes-related complications which occur in 10%-25% in diabetic patients. They are an important cause of morbidity and mortality in diabetes. This retrospective study aimed to assess, using an administrative database, the morbidity and the mortality risk of infected diabetic ulcers. METHODS: It's a retrospective study enrolling 644 patients operated on for a diabetic foot between January 1st, 2012 and December 31st, 2016 in the surgical department B of Charles Nicolle's Hospital. Logistic regression identified independent predictive factors of major amputation, morbidity and mortality. RESULTS: This retrospective study showed that "Cardiac failure" (OR=5.00, 95%CI [1.08  23.25], p=0.039), "Admission in the ICU in the first 48h" (OR=12.76, 95%CI [4.92  33.33], p<0.001) and "Major amputation" (OR=6.40, 95%CI [2.41  16.94], p<0.001) were considered as independent predictive factors of mortality. As concerns morbidity, Cardiac failure (OR=0.163, 95%CI [0.055  0.479], p=0.001) and organ failure at admission (OR=0.017, 95%CI [0.004  0.066], p=0.017) were predictive factors of admission in the ICU during the first 48 hours. Besides, advanced age (OR=1.033, 95%CI [1.014  1.052], p=0.001), Pre-operative stay (OR=1.093, 95%CI [1.039  1.151], p=0.001) and admission in the ICU during the first 48 hours (OR=0.142, 95%CI [0.071  0.285], p<0.001) were predictive factors of major amputation. Moreover, Cardiac failure (OR=0.517, 95%CI [0.298  0.896], p=0.019), admission in the ICU during the first 48 hours (OR=0.176, 95%CI [0.088  0.354], p<0.001)  and Pre-operative stay (OR=1.083, 95%CI [1.033  1.134], p=0.001) were predictive variables of complicated post-operative course. Admission in the ICU during the first 48h (OR=0.140, 95%CI [0.48  0.405], p<0.001), major amputation (OR=0.170, 95%CI [0.76  0.379], p<0.001), and number of ICU stays (OR=3.341, 95%CI [1.558  7.164], p=0.002) were predictive factors of medical complications. Preoperative stay (OR=1.091, 95%CI [1.038  1.147], p=0.001) was predictive of reintervention. CONCLUSIONS: Our retrospective study assessed that mortality rate was inferior when the patient didn't have amputation, no post-operative complications and no reintervention. The main limitation of our study was the retrospective design.

Prognostic factors in rectal cancer: where is the evidence?

BACKGROUND: In rectal cancer, the 5 years survival is about 53 % for all stages: it remains low in spite of the progress of diagnostic and therapeutic tools. The aim of this work was to provide evidence based answers to the following question: what are the pre, intra and post operative prognostic factors in rectal cancer? METHODS: We have carried out a search in the following data bases: Pubmed, Embase, Cochrane and Scopus. The key words used were: « rectal cancer ¼, « adenocarcinoma ¼, « overall survival ¼, « disease-free survival ¼, « prognosis ¼ and « evidence-based medicine ¼. The overall 5 years survival rate has been retained as primary outcome measure. Recurrence-free survival has been retained as secondary endpoint. Were included meta-analyses and systematic reviews of clinical trials dating back to less than six years. RESULTS:   We retrieved 270 publications, 27 articles only met the above-mentioned eligibility criteria and thereof have been retained in this work. A high operating volume, a specialized surgeon in colorectal surgery, a total mesorectal excision, an adjuvant chemotherapy given within no more than 8 weeks following the curative resection improve prognosis in rectal cancer with level I of evidence. Anastomotic leak and diabetes worsen prognosis in rectal cancer with level I of evidence. Margin of surgical resection must be RO to improve prognosis in rectal cancer with level I of evidence. CONCLUSION: The main prognostic factors found in literature which we should keep in mind are those on which surgeons can  act:  neoadjuvant treatment,  high operating volume of the surgeon,  high tie of the inferior mesenteric  artery,  mesorectal excision , RO resection,  improvement of the techniques of intersphincteric resection and techniques of anastomosis   and adjuvant chemotherapy within less than 8 weeks when appropriate.

Pseudo papillary and solid tumor of the pancreas: a rare tumor and a difficult diagnosis.

The pseudopapillary and solid tumor of the pancreas is a rare disease that accounts for 2% of pancreatic tumors. It affects mainly young, female adults. The clinical features are not specific, hence the diagnostic difficulty and the importance of imaging. The diagnosis is based on pathological examination coupled with immunohistochemistry. The aim of our work was to report the difficulty of the diagnostic procedure in a patient with a pancreatic cystic tumor.

Surgery of the pancreatic cystic echinococcosis: systematic review.

The prevalence of pancreatic cystic echinococcosis (PCE) in the world is low ranging between 0.2% and 0.6%. The diagnosis of PCE is easy when it is associated to other location such as liver, it became difficult when PCE was isolated simulating other diagnosis such as pseudocyst, a choledochal cyst, serous or mucinous cystadenoma and cystadenocarcinoma. This systematic review aimed to provide evidence-based answer to the following questions: (I) what are the efficient tools to affirm the diagnosis of isolated PCE and (II) what are the best therapeutic strategy for the PCE? An electronic search was performed by two authors (W Dougaz, I Bouasker). Medline, Scopus, Embase, Web of Science, Google Scholar and Cochrane collaboration were consulted. The keywords used were "cyst", "echinococcosis", "hydatid cyst" and "pancreas". All abstracts were analyzed followed by extraction of the full text by the same two authors (W Dougaz, I Bouasker), all divergences were resolved by discussion with C Dziri. Recommendations were based on Oxford's classification: (I) what are the efficient tools to affirm the diagnosis of PCE? -ultrasound remains the cornerstone of diagnosis. Magnetic resonance imaging (MRI) reproduces the ultrasound defined features of CE better than computed tomography (CT). MRI with heavily T2-weighted series is preferable to CT. Pancreatic duct MRI should be promising to identify a fistula between PCE and pancreatic duct (level of evidence 3-recommendation B); (II) what are the best therapeutic strategy for the PCE? -surgery is the main treatment of PCE. Open approach is validated. The decision depends of the location of PCE: head versus body and/or tail of the pancreas (level of evidence 5-recommendation D): for the head of the pancreas, the tendency is toward conservative surgery. For body and/or tail of the pancreas, the tendency is toward radical surgery. Medical treatment (albendazole) should be prescribed 1 week before surgery and 2 months during postoperative period (level II evidence and grade C recommendation).

Predictive factors of failure and mortality after CT-Guided percutaneous drainage of infected pancreatic necrosis.

BACKGROUND: The traditional approach to the drainage of infected pancreatic necrosis (IPN) is open necrosectomy. As an alternative to open necrosectomy, percutaneous drainage is the first-line treatment of IPN. This study is aimed to identify predictive factor of failure after CT-guided percutaneous catheter drainage (PCD) of IPN. METHODS: Between June 1st 1988 and October 31th 2011, 26 patients with IPN were treated by PCD. The outcome measures were the failure of the PCD and/or death. A descriptive analysis was performed followed by a comparative analysis of alive versus deceased patients and success group versus failure group. Univariate and multivariate analysis were performed to determine predictive factors of failure after percutaneous drainage or death. RESULTS: The failure and mortality rates were respectively 38% and 34%. The size of catheter inferior to 10 French was the only variable associated with the percutaneous drainage failure (OR=27, CI95% [2.5-284.6], p=0.006]. The collection number on CT scan was associated with mortality (OR=2.2, IC95% [1-5.1], p=0.050). CONCLUSION: PCD with catheter size equal or greater than 10 French is efficient tool for the treatment of IPN. Collection number on CT scan is an independent predictive factor of mortality.

Treatment of inguinal hernia by lichtenstein technique: an open prospective study.

BACKGROUND: Treatment of inguinal hernia is still a challenge for the surgeon. The multitude of surgical techniques attests of the difficulty of choosing the best procedure. In the surgical B department of the Charles Nicolle Hospital we have chosen the Lichtenstein technique since 2008. The aim of this study was to evaluate the immediate and long-term results of this technique and to identify the predictive factors of recurrence. METHODS: This open prospective study included all patients who underwent an elective inguinal hernia repair in the surgical B department of the Charles Nicolle Hospital between June 1st 2008 and December 31st 2009. These patients were regularly followed for at least three years. Hernia's recurrence was the primary study endpoint. Postoperative pain, wound complications, urinary complications were secondary endpoints.  An univariate and multivariate analysis were performed to identify predictive factor of hernia recurrence. RESULTS: 256 men and eight women were involved in this study with a sex ratio to 32. The average age was 54 years, ranging from 18 to 85 years. we identified seven cases of recurrent hernia (2,6%) with a risk of recurrence at five years equal to 4.9%, 95%CI[4,5 - 5,3].Wound complications were present in 90 patients (34%), dominated by serums seen in 12.1% of cases. The scrotal edema was found in 32 patients (12%). Eight patients kept a postoperative pain after three years of follow-up (3%). The presence of coagulation disorders in pre-operative check-up ( OR 32.25, 95% CI [3.33- 333.3], p = 0.003) and the persistence of pain after one year of intervention ( OR 16.12,95% CI [2.68 -100], p = 0.01) were two predictive factors of hernia recurrence. CONCLUSION: The Lichtenstein technique remains the gold standard technique in the treatment of inguinal hernias by open surgery. It is a safe, simple, reproducible procedure with a low recurrence rate.

Prognostic Nutritional Index score is useful to predict post-operative mortality and morbidity in gastric cancer.

Background - The Prognostic Nutritional Index (PNI) score is based on the level of lymphocytes and albuminemia. The aim of this study was to validate the pre-operative PNI score for predicting post-operative mortality and morbidity of patients operated on for gastric cancer. Methods - This retrospective study collected data from patients operated on for a gastric cancer at the surgical unit B of Charles Nicolle's hospital in Tunis between January 1st, 2008 and December 31, 2012. The main outcome measure was post-operative death within 30 days. The secondary outcome was post-operative morbidity (within 30 days). We have performed a descriptive analysis, a univariate and multivariate analysis with logistic regression and a ROC curve analysis. Results - 14 women and 26 men were enrolled, with a sex ratio of 1,85. The mean age was 63 ± 15. Post-operative mortality and morbidity rate were respectively 18% and 28%. The ROC curve allowed us to validate the PNI for predicting post-operative mortality in gastric cancer with a threshold level of 38 with sensitivity 100% and specificity 64%. PNI was also validated for post-operative morbidity with a threshold level of 38 with sensitivity 82% and specificity 66%. Conclusion - PNI was validated for predicting post-operative mortality and post-operative morbidity in gastric cancer.