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.

Intraoperative Ultrasound for Bowel Deep Infiltrating Endometriosis: A Preliminary Report.

The decision to perform either conservative surgery or segmental bowel resection for bowel deep infiltrating endometriosis (DIE) is made intraoperatively, after a preoperative assessment, based on the nodule's features. We introduce a technique to evaluate DIE bowel nodules using laparoscopic intraoperative ultrasound (US) during laparoscopic radical treatment of 9 cases of DIE invading the bowel. Once the bowel lesion was isolated, an intraoperative 12-4-MHz US transducer was placed on the surface of the nodules to study their US features and to gain measurements. Deep infiltrating endometriosis nodules appear at intraoperative US as hypoechoic elliptical lesions with a clear definition of margins and the depth of infiltration of the rectal wall.

TransAnal Minimally Invasive Surgery (TAMIS) with SILS™ port versus Transanal Endoscopic Microsurgery (TEM): a comparative experimental study.

BACKGROUND: TransAnal Minimally Invasive Surgery (TAMIS) has been proposed as an alternative to Transanal Endoscopic Microsurgery (TEM) for resection of benign polyps and early cancers of rectum. Since clinical application has begun in the absence of any experimental validation, we assessed its feasibility and efficacy ex vivo in a pilot study. METHODS: In a dedicated trainer box for transanal procedures, 10 surgeons with no experience in transanal surgery were asked to perform a dissection/suture task using both TAMIS and TEM in randomly allocated order. Surgeons were asked to dissect two identically drawn lesions of ~3 cm in larger diameter. Precision of dissection was assessed using a quantitative photographic method, while the time needed for dissection and suturing was considered a measure of quantitative evaluation. Each participant expressed a subjective opinion regarding difficulty with dissection, difficulty with suturing, vision quality, and conflict between instruments on a scale from 1 to 5. RESULTS: No difference was observed between the two techniques regarding the accuracy of dissection as the margin was interrupted along 4.1 % of the circumference in the TEM group compared with 2.48 % in the SILS group (P = 0.271). Dissection and suturing were significantly quicker in the TEM group [04:30 vs. 06:35 min (P = 0.049) and 14:34 versus 19:18 min (P = 0.003)]. In three cases in the SILS group, completing the suture was not considered possible, and the procedures were terminated by TEM. Subjective evaluation revealed a better appreciation of TEM in all proposed comparisons: dissection (2.6 vs. 3.5, P = 0.004), suturing difficulty (3.1 vs. 4.6, P < 0.001), quality of vision (2.3 vs. 2.8, P = 0.18), and instrument conflicts (3.1 vs. 4.0, P = 0.054). CONCLUSIONS: In the ex vivo setting, both techniques were comparable for achieving a good dissection, although TAMIS failed to prove effective in suturing the rectal wall. Moreover, TEM was significantly quicker despite the small groups and was better appreciated by the surgeons.

Comparison of endoscopic task performance with crossed versus uncrossed straight and curved instruments through a single port.

BACKGROUND: Despite advancing technology for single-incision minimal access surgery, there have been no reports on the optimal operating setup and the instruments for use through a single port. This study therefore aimed to compare task performance in single-port surgery between crossed and uncrossed instruments (straight and distally coaxially curved). METHODS: A dedicated trainer box was used to investigate the performance of two tasks (pick-transfer-place and dissection) by 18 surgical residents using two randomly allocated manipulating systems: (1) a conventional, uncrossed manipulation system (UCMS), with surgery through a cone-shaped 40-mm port using coaxially curved or straight instruments subtending a 30° manipulation angle, and (2) a crossed manipulation system (CMS), with surgery through a cylindrical miniport (25 mm) using coaxially curved instruments. RESULTS: The pick-transfer-place task performed with the UCMS enabled comparison between straight and curved coaxial instruments and showed that although the participants moved the same number of objects with either type (p = 0.464), they dropped a significantly more objects with straight instruments (1.5 ± 1.33 vs. 0.61 ± 0.85; p = 0.013). The execution of this task with the CMS (curved instruments only) provided a performance (dropped objects and error rates) equal to that obtained by the UCMS with curved instruments (p = 0.521, p = 0.989). The dissection task with the UCMS showed no difference between straight and curved coaxial instruments in dissection accuracy (75.6 vs. 75.5%; p = 0.950) or execution times (258 vs. 302 s; p = 0.367). The performance of this task by the CMS and the UCMS (with curved coaxial instruments) was equivalent with regard to dissection accuracy (p = 0.849) and execution time (p = 0.402). CONCLUSIONS: Using the UCMS, task performance is better with distally curved coaxial instruments. The CMS (with curved instruments) gives a task performance equivalent to that obtained with UCMS.

Electrothermal bipolar vessel sealing system vs. harmonic scalpel in colorectal laparoscopic surgery: a prospective, randomized study.

PURPOSE: This study was designed to compare the efficacy and safety of laparoscopic colorectal surgery performed with the aid of LigaSure vessel-sealing system or Ultracision. METHODS: Patients eligible for elective laparoscopic right or left hemicolectomy or anterior resection of rectum were randomly assigned to either the use of Ligasure or Ultracision. The primary end point was intraoperative reduction of blood loss. Secondary end points were intraoperative and postoperative morbidity and operative time. RESULTS: Between April 2005 and December 2006, 140 consecutive patients were included in the study (70 Ligasure and 70 Ultracision. We performed 31 right hemicolectomies, 69 left hemicolectomies, and 40 anterior resections of rectum. Blood loss was 109.6 ml (Ultracision 107.9 ml vs. Ligasure 111.2 ml, P value = 0.72). Intraoperative complication rate was 2.8 percent (Ultracision 1.4 percent vs. Ligasure 4.2 percent, P value < 0.01). Postoperative mortality was 0.7 percent. The overall conversion rate was 7.8 percent, 6 in the Ligasure group and 5 in the Ultracision group (P value = 0.09). Operative time, considered from pneumoperitoneum to minilaparotomy, was 115.7 minutes (Ultracision 114.8 minutes vs. Ligasure 116.3 minutes, P value = 0.89). CONCLUSIONS: Results showed that Ligasure and Ultracision are both useful instruments for laparoscopic colorectal surgery with no significant difference in terms of intraoperative/postoperative morbidity and operative time. Choice of which technique to perform should be according to the surgeon's preference.

Ultrasonic versus standard electric dissection in laparoscopic colorectal surgery: a prospective randomized clinical trial.

OBJECTIVE: To assess the safety and efficacy of the ultrasonic dissection (UC) compared with standard electrosurgery (ES) in laparoscopic colorectal surgery. BACKGROUND DATA: High-frequency ultrasound energy was introduced in laparoscopic surgery to improve dissection and coagulation. Very limited data have been published on its use in laparoscopic colorectal surgery. METHODS: Patients eligible for elective laparoscopic right or left hemicolectomy (RH and LH), sigmoidectomy (SG), or low anterior resection (LAR) were randomized to either UC or ES. The following data were collected and analyzed: preoperative data (individual patient data, indication for surgery), intraoperative data (conversion to open surgery, conversion ES to UC, operative time, blood loss, complication rate), and postoperative data (morbidity and mortality, volume of drainage, hospital stay). RESULTS: Between January 2002 and December 2003, 171 patients underwent elective laparoscopic colorectal resection. Twenty-5 patients did not satisfy the inclusion criteria and were excluded. The diagnosis of the remaining 146 patients was diverticulitis (44), colonic adenoma (31), adenocarcinoma (70), or epidermoid carcinoma (1). These patients underwent laparoscopic RH (28), LH (31), SG (47), or LAR (40). There were no differences in preoperative data. The overall conversion rate to open surgery was 11.6%, with no differences between the two groups; 20.8% undergoing ES were converted to UC, more frequently during right hemicolectomy or low anterior resection. Operative time, the primary endpoint of this study, did not differ between the two groups: UC 93 minutes versus ES 102.6 minutes (P = 0.46). Intraoperative blood loss was significantly less in UC 140.8 mL versus ES 182.6 mL (P = 0.032). No differences were observed in postoperative morbidity or other preoperative or postoperative parameters. CONCLUSIONS: UC is a useful device in laparoscopic colorectal surgery that facilitates completion of difficult cases and reduces intraoperative blood loss. Nevertheless, the majority of laparoscopic procedures can be completed with ES. Therefore, selective use of UC appears to be the most cost-effective policy.