Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn's disease (ENDOCIR study): an open-label, multicentre, randomized trial.

BACKGROUND: Stenosis is one of the most common complications in patients with Crohn's disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previous surgery. Self-expandable metal stents (SEMS) may be a suitable treatment option for longer stenoses. To date, however, there is no scientific evidence as to whether endoscopic (EBD/SEMS) or surgical treatment is the best approach for de novo or primary stenoses that are less than 10 cm in length. METHODS/DESIGN: Exploratory study as "proof-of-concept", multicentre, open-label, randomized trial of the treatment of de novo stenosis in the CD; endoscopic treatment (EBD/SEMS) vs surgical resection (SR). The type of endoscopic treatment will initially be with EDB; if a therapeutic failure occurs, then a SEMS will be placed. We estimate 2 years of recruitment and 1 year of follow-up for the assessment of quality of life, costs, complications, and clinical recurrence. After the end of the study, patients will be followed up for 3 years to re-evaluate the variables over the long term. Forty patients with de novo stenosis in CD will be recruited from 15 hospitals in Spain and will be randomly assigned to the endoscopic or surgical treatment groups. The primary aim will be the evaluation of the patient quality of life at 1 year follow-up (% of patients with an increase of 30 points in the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The secondary aim will be evaluation of the clinical recurrence rate, complications, and costs of both treatments at 1-year follow-up. DISCUSSION: The ENDOCIR trial has been designed to determine whether an endoscopic or surgical approach is therapeutically superior in the treatment of de novo stenosis in CD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home.

Transanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial.

BACKGROUND: Transanal total mesorectal excision (TaTME) is a minimally invasive surgical technique that tries to avoid conversion to open surgery. However, specific intraoperative complications and local recurrences have cast some doubt on the suitability of the technique. The primary endpoint of the present study was a composite outcome of conversion surgery. Secondary objectives were to assess postoperative recovery, and pathological and oncological outcomes. METHODS: This was a prospective, multicentre, randomized, controlled open-label study of patients diagnosed with mid and low rectal adenocarcinoma who underwent laparoscopic TaTME or laparoscopic total mesorectal excision (LaTME). The TaTME technique comprised intracorporeal resection and anastomosis. Main outcomes were conversion to open surgery. Secondary outcomes were postoperative morbidity, mortality, pathological, oncological results, and survival. Modified intention-to-treat (mITT) and per-protocol analyses were performed. RESULTS: The study was conducted between April 2015 and May 2021. Patients were randomized to the LaTME (57 patients) or TaTME (59) group. Fifty patients from the LaTME group and 55 from the TaTME group were eligible for mITT analysis. The procedure was converted to open surgery in 11 patients (11 per cent): 10 (20 per cent) in the LaTME group and 1 (2 per cent) in the laparoscopic TaTME group (difference 18.8, 95 per cent c.i. 30 to 7; P = 0.003). No significant differences were found in terms of postoperative recovery and morbidity at 30 days; nor were there significant differences in anastomotic leakage, although it was less common in laparoscopic TaTME. With a median follow-up of 39 months, there were three instances of local recurrence (6.1 per cent) in the LaTME group and one (1.8 per cent) in the laparoscopic TaTME group (95 per cent c.i. 60 to 69; P = 0.3). Registration number: NCT02550769 (http://www.clinicaltrials.gov). CONCLUSION: The conversion rate was significantly lower in laparoscopic TaTME than in LaTME. At centres with experienced surgeons, laparoscopic TaTME can avoid conversion to open surgery.

Prospective evaluation of bowel dysfunction after rectal cancer surgery.

PURPOSE: Bowel dysfunction after rectal cancer surgery may significantly affect the quality of life. Our study aimed to estimate the incidence and characterize the low anterior resection syndrome (LARS). METHODS: Prospective evaluation of patients treated with anterior resection for rectal cancer at two hospitals followed for 12 months after ileostomy reversal. The assessment was performed at baseline, after neoadjuvant treatment, and 1 month, 6 months, and 12 months after bowel transit reconstruction using several scores (Bristol scale, LARS score, Memorial Sloan Kettering bowel function instrument, Fecal Incontinence Quality of Life, EORTC-QLQ30, and a visual analogue scale). RESULTS: Of 205 patients diagnosed with rectal cancer, 78 were followed for 12 months after the exclusion criteria. "Major LARS" at 1 month, 6 months, and 12 months was 55.6%, 47.3%, and 34.6%, respectively. At 12 months, patients experienced significantly less diarrhea, higher LARS score, more percentage of "major LARS," and worse MSK-BFI score compared to baseline. Regarding the quality of life at 12 months, 77.7% of patients with "major LARS" reported impact according to the anchor question of the LARS score; all FIQL subscales were significantly lower; the overall EORTC-QLQ30 score and the functional subscales significantly correlated with the LARS and the MSK-BFI scores. CONCLUSIONS: Bowel dysfunction with an impact on the quality of life is common after rectal cancer surgery. The knowledge of the potential consequences of the treatments is essential to be able to provide patients with the best possible information.