Clinical oncology research; Review on contemporary methodology standards.

Evaluation of novel treatments through clinical trials remains the backbone of oncological clinical research, but only a minor portion have been tested in Phase III trials. The continued publication of underpowered trials provides an ongoing need for meta-analyses to detect clinically significant outcomes. Although tumor relapse and survival are important issues and easily measured outcomes in trials, they are often not the most relevant indicators for treatment success. As diagnostic technologies and treatments continue to advance, methodologies defining high quality studies have been established, but still enthusiasm to adopt novel technologies that leads to studies holding well-described bias that do not aid the rational use of the studied test. Global awareness of such bias and standard research methodology is the clue toward iconic studies giving rational supporting novel cancer treatments and patients' support.

Cholecysto cholangiography versus cystic duct cholangiography in laparoscopic cholecystectomy: a prospective controlled randomized trial.

This study evaluated the safety and effectiveness of cholecysto-cholangiography (CCC), an extremely rapid and easy way of imaging the biliary tree during laparoscopic cholecystectomy and a viable alternative to cystic duct cholangiography in the era of minimal invasive surgery. Sixty patients with symptomatic gallbladder stones were studied in this series, 30 were evaluated for cholecysto-cholangiography and other 30 for transcystic-cholangiography. The success rate in cholecysto-cholangiography approached 80% with excellent quality films obtained. Delineation of anatomy approached 85%; 75% for cholecysto-cholangiography and transcystic cholangiography respectively. Exposure time to radiation compares favourably with cystic duct cannulation with a mean time 2.4 min. Cholecysto-cholangiography added less than 11 mins to the procedure; mean 10.4 mins, while transcystic cholangiography added an extra 30 mins; mean 31 mins. There were no cholangiogram related complications or false positive findings with a smooth for two months follow up.

Botulinum toxin injection versus lateral internal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial.

BACKGROUND: Although lateral internal sphincterotomy has been the gold standard of treatment for chronic anal fissure, the main concern remains its effects on anal continence. Intrasphincteric injection of botulinum toxin seems to be a reliable option providing temporary alleviation of sphincter spasm and allowing the fissure to heal. The aim of the present prospective controlled randomized study was to compare the outcome of lateral internal sphincterotomy and botulinum toxin injection treatments in patients with uncomplicated chronic anal fissure. METHODS: Eighty consecutive patients with uncomplicated chronic anal fissure who had failed conservative treatment were randomized to receive either intrasphincteric injection of botulinum toxin (BT) or lateral internal sphincterotomy (LIS). Postoperative pain relief, healing of fissure, continence scores, and fissure relapse during 18 weeks of follow-up were the outcomes assessed. RESULTS: There was a statistically significantly higher healing in the LIS group than the BT group (p = 0.0086 and 95% CI = 7.38-45.69%). In addition, LIS was associated with a high rate of anal incontinence as compared to BT (p = 0.0338 and 95% CI = -1.64-27.53%). The recurrence rate in the BT group was significantly higher statistically than that in the LIS group (p = 0.0111 and 95% CI = 6.68-46.13%). CONCLUSIONS: Surgical internal sphincterotomy has a higher healing rate and a lower recurrence rate than intrasphincteric injection of botulinum toxin in the treatment of uncomplicated chronic anal fissure. Injection of botulinum toxin, however, is a simple noninvasive technique that avoids the greater risk of incontinence. It could be used as the first therapeutic approach in patients without clinical risk factors of recurrence.

Tension-free repair versus Bassini technique for strangulated inguinal hernia: A controlled randomized study.

UNLABELLED: By Evidence Based Medicine (EBM) principles, several meta-analyses concluded that use of mesh is superior to the non-mesh operations in inguinal hernia surgery. Wound infection is a potential complication of all hernia repairs and deep-seated infection involving an inserted mesh may result in chronic groin sepsis. In the event of incarcerated or strangulated hernias, however; placement of prosthetic material is presumed to increase that risk of infection. AIM: Aim of the study is to compare the outcome of tension-free mesh repair to Bassini technique used to treat strangulated inguinal hernia. PATIENTS AND METHODS: In the period from May 2004 to December 2006, 54 patients were submitted to emergency operation because of strangulated inguinal hernia. The patients were randomized into two groups (27 patients in each group). Group A patients underwent open tension-free anterior repair utilizing a monofilament polypropylene mesh according to Lichtenstein "tension-free" technique, whereas group B patients underwent Bassini technique. Mesh hernioplasty was not attempted in patients with preoperative peritonitis, inflammatory hernia and for those in whom bowel resection was perfumed for ischemic necrosis caused by strangulated inguinal hernia and they were excluded from the study. Assessment of the primary outcome included surgical complications and hospital stay and secondary outcome was the recurrence of hernia. RESULTS: Postoperative complication rate did not differ significantly between the two groups. Postoperative hospital stay was also significantly longer in group B compared to group A (5+/-3.4 days versus 3+/-2.1 days, p<0.01). During the follow-up, (mean 22+/-6months), three patients had recurrence after Bassini operation (group B), but there was no recurrent hernia after mesh herniorrhaphy (group A) (0/27=0% versus 3/27=7, 11.1%, p<0.001). CONCLUSION: The use of Lichtenstein "tension-free" technique in emergency treatment of strangulated inguinal hernia is safe, effective with an acceptably low rate of postoperative complications and without recurrence.

Gastrointestinal stromal tumors (GISTs): clinical presentation, diagnosis, surgical treatment and its outcome.

This study included 13 selected patients treated by surgical excision for lesions that proved postoperatively to be gastrointestinal stromal tumors (GISTs) by histopathological and immunohistochemistry studies. The demographic, clinical and operative reports data were collected. Eight cases were gastric GISTs, four cases were small bowel GISTs (jejunum 1 & ileum, 3) and GIST of the sigmoid colon was in one patient. Eight cases presented at the emergency department due to hematemesis (3), gastrointestinal obstruction (3), bowel perforation (1) and severe bleeding per rectum (1). Three cases presented with a feeling of abdominal fullness and ill-defined palpable abdominal mass. Two cases were discovered incidentally during GIT endoscopy for dyspepsia. Diagnosis of GISTs was presumed on clinical basis and operative findings from gross morphological features. Complete resection (R0) was achieved for 12 tumors (92.3%). The immunohistochemistry profile was positive for C-kit for all cases. One operative death was due to massive pulmonary embolism. Postoperative complications occurred in three (23%) as upper GIT bleeding (1), biliary gastritis (1) and wound infection (1), and one (7.69%) of ileum tumor recurrence.