BackgroundTotal mesorectal excision is the standard surgical treatment for mid- and low-rectal cancer. Laparoscopy represents a clear leap forward in the management of rectal cancer patients, offering significant improvements in post-operative measures such as pain, first bowel movement, and hospital length of stay. However, there are still some limits to its applications, especially in difficult cases. Such cases may entail either conversion to an open procedure or positive resection margins. Transanal endoscopic proctectomy (ETAP) was recently described and could address the difficulties of approaching the lower third of the rectum. Early series and case-control studies have shown favourable short-term results, such as a low conversion rate, reduced hospital length of stay and oncological outcomes comparable to laparoscopic surgery. The aim of the proposed study is to compare the rate of positive resection margins (R1 resection) with ETAP versus laparoscopic proctectomy (LAP), with patients randomly assigned to each arm.Methods/designThe proposed study is a multicentre randomised trial using two parallel groups to compare ETAP and LAP. Patients with T3 lower-third rectal adenocarcinomas for whom conservative surgery with manual coloanal anastomosis is planned will be recruited. Randomisation will be performed immediately prior to surgery after ensuring that the patient meets the inclusion criteria and completing the baseline functional and quality of life tests. The study is designed as a non-inferiority trial with a main criterion of R0/R1 resection. Secondary endpoints will include the conversion rate, the minimal invasiveness of the abdominal approach, postoperative morbidity, the length of hospital stay, mesorectal macroscopic assessment, functional urologic and sexual results, faecal continence, global quality of life, stoma-free survival, and disease-free survival at 3 years. The inclusion period will be 3 years, and every patient will be followed for 3 years. The number of patients needed is 226.DiscussionThere is a strong need for optimal evaluation of the ETAP because of substancial changes in the operative technique. Assessment of oncological safety and septic risk, as well as digestive and urological functional results, is particularily mandatory. Moreover, benefits of the ETAP technique could be demonstrated in post-operative outcome.Trial registrationClinicalTrial.gov: NCT02584985.
Date and version identifier: Version n°2 – 2015 July 6.
Combining an endoscopic transanal TME and a single laparoscopic ileostomy-site proctectomy is a promising minimally invasive approach for the treatment of low rectal cancer.
Earn Continuing Education (CME) credit online at cme.lww.com. This activity has been approved for AMA PRA Category 1 credit. TM Funding/Support: None reported.
Background Defining severe postoperative ileus in terms of consequences could help physicians standardize the management of this condition. The recently described classification based on consequences requires further investigation. The aim of this study was to obtain a snapshot of postoperative ileus in patients undergoing colorectal surgery within enhanced recovery programs and to identify factors associated with non-severe and severe postoperative ileus. Methods This prospective registry data analysis was conducted in 40 centers in five different countries. A total of 786 patients scheduled for colorectal surgery within enhanced recovery programs were included. The primary endpoint was the incidence rate of postoperative ileus as defined by Vather et al.Results A total of 121 patients experienced postoperative ileus (15.4%). Non-severe POI occurred in 48 patients (6.1%), and severe postoperative ileus occurred in 73 patients (9.3%). In multivariate analysis, the male gender and intra-abdominal complications were associated with severe postoperative ileus: odd ratio (OR) = 2.03 [95% confidence interval (CI) 1.14-3.59], p = 0.01 and OR = 3.60 [95% CI 1.75-7.40], p \ 0.0001, respectively. Conversely, open laparotomy and urinary retention were associated with non-severe POI: OR = 3.03 [95% CI 1.37-6.72], p = 0.006 and OR = 2.70 [95% CI 0.89-8.23], p = 0.08, respectively. Conclusions Postoperative ileus occurred in 15% of patients after colorectal surgery within enhanced recovery programs. For 60% of patients, this was considered severe. The physiopathology of these two entities could be different, severe POI being linked to intraabdominal complication, while non-severe POI being linked with risk factors for ''primary'' POI. The physician should pay attention to male patients having POI after colorectal surgery and look for features evocating intraabdominal complications.
Severe AKI, is common with increased duration of hepatectomy, was associated with poor short-term outcomes, and can be predicted by operative duration greater than 250 minutes.
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