Aim
To assess the effectiveness of transanal irrigation (TAI) compared with posterior tibial nerve stimulation (PTNS) in severe and chronic low anterior resection syndrome (LARS).
Method
A two‐group parallel, open‐label randomized controlled trial carried out in a single university hospital. The study population included patients with a LARS scale score of more than 29 points who had undergone rectal surgery more than 1 year previously. These were randomly allocated, with a central randomization system, following a 1:1 sequence to TAI or PTNS. The main study outcome was to achieve a reduction of at least one LARS grade in at least 50% of the patients, for each intervention.
Results
A total of 27 patients (TAI = 13, PTNS = 14) were randomized. Both groups were similar with regard to confounding factors. Four patients were excluded because of intercurrent disease or early dropout, leaving 23 (TAI, n = 10; PTNS, n = 13) for analysis. Eight out of 10 and 4 out of 13 patients were downgraded with TAI and PTNS, respectively. The median LARS score decreased from 35 [interquartile range (IQR) 32–39] to 12 (IQR 12–26) (P = 0.021) for the TAI group and from 35 (IQR 34–37) to 30 (IQR 25–33) (P = 0.045) for the PTNS group. The Vaizey score fell from 15 (IQR 11–18) to 6 (IQR 4–7) (P = 0.037) and from 14 (IQR 13–17) to 9 (IQR 7–10) (P = 0.007) with TAI and PTNS, respectively, with 80% and 38% of patients, respectively, showing decreases of more than 50%. Improvement in quality of life was observed in both groups.
Conclusion
Both treatments improved the LARS score in this study but this was only significant in the TAI group.
BACKGROUND:Recently, positive circumferential resection margin has been found to be an indicator of advanced disease with a high risk of distant recurrence rather than local recurrence.
OBJECTIVE:The study aimed to analyze the prognostic impact of the circumferential resection margin on longterm oncological outcomes in patients with rectal cancer.DESIGN: This was a multicenter, propensity scorematched (2:1) analysis comparing the positive and negative circumferential resection margins.
SETTINGS:The study was conducted at 5 high-volume centers in Spain.
PATIENTS:Patients who underwent total mesorectal excision with curative intent for middle-low rectal cancer between 2006 and 2014 were included.
MAIN OUTCOME MEASURES:The main outcomes were local recurrence, distant recurrence, overall survival, and disease-free survival.
RESULTS:The unmatched initial cohort consisted of 1599 patients, of whom 4.9% had a positive circumferential resection margin. After matching, 234 patients were included (156 with a negative circumferential margin and 78 with a positive circumferential margin). The median follow-up period was 52.5 (22.0-69.5) months. Local recurrence was significantly higher in patients with a positive circumferential margin (33.3% vs 11.5%; p < 0.001). Distant recurrence was similar in both groups (46.2% vs 42.3%; p = 0.651). There were no statistically significant differences in 5-year overall survival (48.6% vs 43.6%; p = 0.14). Disease-free survival was lower in patients with a positive circumferential margin (36.1% vs 52.3%; p = 0.026).
LIMITATIONS:This study was limited by its retrospective design. The different neoadjuvant treatment options were not included in the propensity score.
CONCLUSIONS:The positive circumferential resection margin was associated with a higher local recurrence rate and worse disease-free survival in comparison with the negative circumferential resection margin. However, the positive circumferential resection margin was not a prognostic indicator of distant recurrence and overall survival. See Video Abstract at http://links.lww.com/DCR/ B950.
3501 Background: The standard surgical treatment of rectal adenocarcinoma above T1 is total mesorectal excision (TME), but it is associated with high morbidity and quality of life disorders. Transanal endoscopic microsurgery (TEM) achieves minimal postoperative morbidity rates. The treatment of T2, T3 superficial, N0, M0 rectal cancers is TME due to local excision achieving high recurrence rates. Initial reports of preoperative chemoradiotherapy (CRT) in association with TEM shows reduction in local recurrence. The TAU-TEM study aims to demonstrate the non-inferiority of the oncological outcomes and the improvement in morbidity and quality of life achieved with CRT-TEM compared with TME. Methods: Prospective, multicenter, randomized controlled non-inferiority trial including patients with rectal adenocarcinoma less than 10 cm from the anal verge and up to 4 cm in size, staged as T2T3sN0M0. Patients were randomized to: CRT-TEM (Arm A) or TME (Arm B). Postoperative morbidity and mortality were recorded and patients in both arms completed quality of life questionnaires when starting treatment and 6 months after surgery. Patients attended follow-up controls for local and systemic relapse. Trial registration: ClinicalTrials.gov Identifier: NCT01308190. Results: From July/2010 to October/2021, 173 patients from 17 Spanish hospitals were included (Arm A: 86, Arm B: 87). Ten were excluded after randomization (Arm A: 4, [3 re-staged > T2T3sN0M0, 1 refused follow-up study]; Arm B: 6 [4 refused the arm, 2 re-staged > T2T3sN0M0]). Therefore, the patients with modified intention to treat analysis were: TME, 81 and CRT-TEM, 82. There was no mortality after CRT. In this group, 2 patients abandoned neoadjuvant therapy; thus 80/82 (97.6%) completed CRT. The CRT-morbidity was low (25/82, 30%) and of low grade (95% G1-2). In the CRT-TEM group, MRI showed disease progression in 3 patients who were treated with TME. Finally, 77 patients underwent TEM surgery. One patient died in each arm (1.2%). Postoperative morbidity was 41/81 (50.6%) (Arm B) and 17/82 (20.7%) (Arm A) (p < 0.001, 95 CI% 43.9 to 15.9). Median Comprehensive Complication Index was 8.7 (IQR 20.9) Arm B and 0 (IQR 0) Arm A (p < 0.001). Median hospital stay was 7 days (IQR 7) Arm B and 2 days (IQR 2) Arm A (p < 0.001). Complete response in Arm A was 45.3% (34/75 patients) with 5.3% ypT3 (4/75 patients) and in Arm B: pT1 (12.3%; 10/81patients), deep-pT3 (4.95; 4/81patients), pN1 (21%; 17/81). Conclusions: CRT-TEM treatment obtains high pathological complete response rates (45.3%), with a high CRT compliance rate (97.6%) and low morbidity. Postoperative complications and hospitalization are significantly lower in the CRT-TEM group. We await the results of the follow-up. Clinical trial information: NCT01308190.
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