Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before or after ADjuvant therapy) randomised controlled trial.

INTRODUCTION: Temporary ileostomy is a valuable aid in reducing the severity of complications related to rectal cancer surgery. However, it is still unclear what is the best timing of its closure in relation to the feasibility of an adjuvant treatment, especially considering patient-reported outcomes and health system costs. The aim of the study is to compare the results of an early versus late closure strategy in patients with indication to adjuvant chemotherapy after resection for rectal cancer. METHODS AND ANALYSIS: This is a prospective multicentre randomised trial, sponsored by Rete Oncologica Piemonte e Valle d'Aosta (Oncology Network of Piedmont and Aosta Valley-Italy). Patients undergone to rectal cancer surgery with temporary ileostomy, aged >18 years, without evidence of anastomotic leak and with indication to adjuvant chemotherapy will be enrolled in 28 Network centres. An early closure strategy (between 30 and 40 days from rectal surgery) will be compared with a late one (after the end of adjuvant therapy). Primary endpoint will be the compliance to adjuvant chemotherapy with and without ileostomy. Complications associated with stoma closure as well as quality of life, costs and oncological outcomes will be assessed as secondary endpoints. ETHICS AND DISSEMINATION: The trial will engage the Network professional teams in a common effort to improve the treatment of rectal cancer by ensuring the best results in relation to the most correct use of resources. It will take into consideration both the patients' point of view (patient-reported outcome) and the health system perspective (costs analysis). The study has been approved by the Ethical Review Board of Città della Salute e della Scienza Hospital in Turin (Italy). The results of the study will be disseminated by the Network website, medical conferences and peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT04372992.

Laparoscopic vs open restorative proctocolectomy with IPAA for ulcerative colitis: Impact of surgical technique on creating a well functioning pouch.

BACKGROUND: Patients with ulcerative colitis are often young, and proctocolectomy with restorative ileo-pouch anal anastomosis is a crucial act that can improve or worsen the quality of the rest of their lives. The literature is scant on long-term functional outcomes after laparoscopy. The purpose of this study was to investigate results in terms of pouch function after standardized total laparoscopic technique compared with open intervention. MATERIALS AND METHODS: This was a retrospective comparative study. Cases were collected from the prospectively-maintained database of the Unit of General and Oncologic Surgery, XXX, Torino, Italy. Patients treated between May 2005 and May 2015 with three-stage laparoscopic or open proctocolectomy and ileo-pouch anal anastomosis were enrolled. The primary study endpoint was the percentage of well-functioning pouches. Secondary endpoints were postoperative early and late outcomes such as morbidity and pouch survival. RESULTS: Of the 78 patients identified, 48 underwent the open technique and 30 underwent laparoscopy. Median follow-up was 4 years. The overall complication rates were 19% and 13% (p = 0.5), and there were major complications (Clavien-Dindo III-IV) in 14.6% and 13.3% of patients in the open and laparoscopic groups, respectively (p = 0.8). Late complications occurred in 26 patients. Nine (18.8%) and 5 (16.7%) patients had pouchitis (p = 0.8), and 6 (12.5%) and 2 (6.7%) had cuffitis in the open and laparoscopic groups, respectively (p = 0.70). Pouch failure occurred in 2 patients (4.2%) in the open group and 2 (6.7%) in the laparoscopic group. The pouch was observed to be functioning very well in 18 patients (37.5%) in the open group and in 17 patients (56%) in the laparoscopic group (p = 0.09). The study was limited by its retrospective, nonrandomized design. CONCLUSION: Our data demonstrated similar early and late results after total laparoscopic and open proctocolectomy, in particular concerning pouch function.

High incidence of trocar site hernia after laparoscopic or robotic Roux-en-Y gastric bypass.

BACKGROUND: Trocar Site Hernia (TSH) seems to represent a rare surgical complication, but available data are based only on symptomatic patients and clinically diagnosed cases; moreover, no data are available concerning TSH incidence after robotic-assisted procedures. Aims of the study were to asses TSH incidence in obese patients who underwent Roux-en-Y gastric bypass (RYGB) and to compare it between robotic-assisted and standard laparoscopy. METHODS: Patients who underwent RYGB between November 2007 and June 2012 underwent a clinical examination and an ultrasonography study of the abdominal wall by a single operator. RESULTS: 150 patients entered the study, 102 in the laparoscopic and 48 in the robotic group. Mean pre-operative weight and BMI were 129.3 kg and 47.4 kg/m(2), respectively; both were higher in the laparoscopic group (134.7 vs 117.6 kg, p < 0.001; 49.2 vs 43.8 kg/m(2), p < 0.001), while pre-operative comorbidities were not significantly different between groups. Operative time was lower in the laparoscopic group (182.7 vs 284.0 min, p < 0.001), while post-operative complications were not different between groups. The overall incidence of TSH was 39.3% (59/150); incidence was 35.3% (36/102) in the laparoscopic and 47.9% (23/48) in the robotic group (p = 0.195). There were no significant differences between patients with and without TSH, except for higher post-operative wound complication in patients without TSH (22 vs 6.8%, p = 0.024; OR 0.26). CONCLUSIONS: TSH revealed a high incidence in a bariatric surgery population, suggesting that it represents a strongly underestimated complication; furthermore, the present study showed a trend towards a higher incidence of TSH in patients who underwent robotic-assisted bariatric surgery.

Transanal endoscopic microsurgery after endoscopic resection of malignant rectal polyps: a useful technique for indication to radical treatment.

BACKGROUND: Management of malignant rectal polyps (MRPs) after endoscopic polypectomy (EP) is still debated. It is sometimes difficult to decide whether to simply follow-up (FU) or to treat such a removed lesion. Transanal endoscopic microsurgery (TEM) could have a role both in T staging and in treating MRPs after EP. METHODS: Patients who underwent a full-thickness TEM within 3 months after an EP between January 2008 and October 2012 were retrospectively analyzed. If post-TEM histology showed locally advanced rectal cancer, patients underwent a total mesorectal excision (TME) within 4-6 weeks. Patients without malignant disease or pT1sm1 cancers at post-TEM histology were followed up every 3 months for 2 years with clinical examination, flexible rectal endoscopy, and neoplastic markers monitoring. RESULTS: A total of 39 patients were included. Post-EP histology was adenocarcinoma in 27/39 cases (69.2 %) and adenoma in 12/39. Mean operative time was 64.2 min; no 30-day mortality occurred; 30-day morbidity was 2.7 % (rectal bleeding in 1/39 cases). Post-TEM histology showed a T2 cancer in 5/39 patients, four with and one without a previous cancer diagnosis, who were further treated by TME (four RARs and one APR) and are disease free with a mean FU of 24.2 months. Post-TEM histology showed adenoma in 10/39 cases and fibrosis in 24/39. These patients are disease free with a mean FU of 13 months. CONCLUSIONS: A full-thickness TEM after EP of MRPs can establish the presence of residual malignant disease and its depth of invasion, precisely defining the indication to TME. In event of benign post-EP histology, TEM must be performed in presence of macroscopic residual disease, in order to obtain an RO resection and finally exclude cancer, while, in absence of macroscopic residual disease, only close FU is required.

Which treatment for large rectal adenoma? Preoperative assessment and therapeutic strategy.

In the present review the authors discuss the standard ways of preoperative work-up for a suspected large rectal non-invasive lesion, comparing East and West different attitudes both in staging and treatment. Looking at the literature and analyzing recent personal data, neither pit-pattern classification, nor EUS, nor biopsy histology, nor lifting sign verification, nor digital examination allow a specificity of more than three fourth of such cases. The authors disquisition about which optimal treatment excludes a role for EMR for the impossibility to obtain a single en-bloc specimen, minimum requirement for a correct lateral and vertical margin assessment. For the same reason ESD should be preferred, although a recent meta-analysis of the literature defined that one fourth of patients undergoing ESD for a preoperatively assessed non-invasive large rectal lesion fail to receive an R0 en-bloc resection. This forces about 10% of patients treated by flexible endoscopy to undergo abdominal surgery, which is about fourfold higher than TEM. While awaiting further implementation of modern technologies both to improve staging and to reduce invasiveness, a full-thickness excision of the rectal wall by TEM still represents the standard treatment even for suspected benign diseases.

Efficacy of the over-the-scope clip (OTSC) for treatment of colorectal postsurgical leaks and fistulas.

BACKGROUND: Colorectal postsurgical leaks and fistulas are severe complications that dramatically increase morbidity and mortality. The aim of this study was to evaluate the clinical impact of over-the-scope clip (OTSC) closure to seal the visceral wall in the management of acute and chronic colorectal postsurgical leaks and fistulas. METHODS: We reviewed our prospective series of acute and chronic colorectal postsurgical leaks and fistulas observed between April 2008 and September 2011 and treated by OTSC. Indications were all cases with an orifice <15 mm in maximum diameter with no extraluminal abscess and luminal stenosis. RESULTS: Endoscopic OTSC closure was performed in 14 consecutive patients (mean defect = 9.1 mm in diameter) by means of 10.5- or 12-mm clips, depending on the wall defect diameter. In eight cases, the indication was an acute leak and in six cases a chronic leak, mainly after anterior rectal resection; two cases were complicated by a rectovaginal fistula and in two other cases by a colocutaneous fistula. OTSC treatment was used to complete endoscopic vacuum-assisted closure of a large defect in three cases. The overall success rate was 86 % (12/14): 87 % (7/8) in acute and 83 % (5/6) in chronic cases. No OTSC-related complications occurred. Further surgery was required in one case. CONCLUSION: Endoscopic OTSC closure of colorectal postsurgical leaks and fistulas is a safe technique, with a high success rate in both acute and chronic cases, including rectovaginal and colocutaneous fistulas.

Role of positron emission tomography-computed tomography in the management of anal cancer.

PURPOSE: Pre- and post-treatment staging of anal cancer are often inaccurate. The role of positron emission tomograpy-computed tomography (PET-CT) in anal cancer is yet to be defined. The aim of the study was to compare PET-CT with CT scan, sentinel node biopsy results of inguinal lymph nodes, and anal biopsy results in staging and in follow-up of anal cancer. METHODS AND MATERIALS: Fifty-three consecutive patients diagnosed with anal cancer underwent PET-CT. Results were compared with computed tomography (CT), performed in 40 patients, and with sentinel node biopsy (SNB) (41 patients) at pretreatment workup. Early follow-up consisted of a digital rectal examination, an anoscopy, a PET-CT scan, and anal biopsies performed at 1 and 3 months after the end of treatment. Data sets were then compared. RESULTS: At pretreatment assessment, anal cancer was identified by PET-CT in 47 patients (88.7%) and by CT in 30 patients (75%). The detection rates rose to 97.9% with PET-CT and to 82.9% with CT (P=.042) when the 5 patients who had undergone surgery prior to this assessment and whose margins were positive at histological examination were censored. Perirectal and/or pelvic nodes were considered metastatic by PET-CT in 14 of 53 patients (26.4%) and by CT in 7 of 40 patients (17.5%). SNB was superior to both PET-CT and CT in detecting inguinal lymph nodes. PET-CT upstaged 37.5% of patients and downstaged 25% of patients. Radiation fields were changed in 12.6% of patients. PET-CT at 3 months was more accurate than PET-CT at 1 month in evaluating outcomes after chemoradiation therapy treatment: sensitivity was 100% vs 66.6%, and specificity was 97.4% vs 92.5%, respectively. Median follow-up was 20.3 months. CONCLUSIONS: In this series, PET-CT detected the primary tumor more often than CT. Staging of perirectal/pelvic or inguinal lymph nodes was better with PET-CT. SNB was more accurate in staging inguinal lymph nodes.

Obstructive colon metastases from lobular breast cancer: report of a case and review of the literature.

INTRODUCTION: Gastrointestinal metastases from breast cancer are rare. One large series reported a rate of 0.7% of gastrointestinal metastatic manifestations from breast cancer, but its true incidence could be underestimated. Here we report a case of bowel obstruction caused by sigmoid metastases from breast cancer and describe its relevance to histological origin and clinical practice. METHODS: The clinical course and histopathology of the case are reviewed and compared with reports of similar cases in the literature. RESULTS: An 80-year-old woman presented with bowel obstruction. Her medical history included infiltrating lobular breast cancer treated with left radical mastectomy 25 years before the current presentation; 13 years later bone metastases developed and were treated with hormone therapy. In 2003 the patient came to our emergency department because of symptoms of bowel obstruction. A computed tomography (CT) scan revealed a mass in the distal sigmoid causing the obstruction. A colostomy was performed, followed by a second operation completed with Hartmann's procedure. Histological examination revealed metastases from invasive lobular carcinoma. The patient was discharged 45 days postoperatively and died 9 months later because of disease progression. CONCLUSIONS: Although gastrointestinal metastases from breast cancer are rare, patients with diagnosed breast cancer, particularly invasive lobular carcinoma, should be regularly followed up with endoscopy, CT, endosonography and PET-CT when abdominal symptoms are present. This could permit early diagnosis of gastrointestinal metastases and improve treatment planning.