TY - JOUR
AU - Parrila, P
AB - Sir In response to comments from Dr Ceelen, we selected the total number of evaluated nodes as the parameter to calculate the sample size required to detect a meaningful treatment effect. With regard to the influence of the patient, the pathologist and the surgeon, in our study these variables were controlled: in the case of the patient, because of the randomization; with regard to both the surgeon and the pathologist, because they were the same for all patients and both groups. Dr Ceelen would have preferred to use the quality of the resected specimen as the parameter but, in our opinion, both variables are of great value for assessing the quality of the surgical procedure from an oncological point of view. In reply to the letter from Mr Christoforidis and Mr Demartines, there has been an ongoing debate about when to call the circumferential rectal margin positive and in our study the cut-off was considered to be 1 mm. We agree with Mr Khan and colleagues that the use of enhanced recovery protocols could shorten the time to intestinal recovery and the duration of hospital stay but this would be the case in both groups. In any case, the laparoscopic approach has additional advantages (less pain, adhesions, incisional hernias, etc.). Concerning blood loss, the total number of patients who required blood transfusion was seven in the open group and two in the laparoscopic group. Regarding the comment made by Mrs Badvie and Mr Hallan, we do not simply assume that this finding can be explained by a type II error, but suggest that such an error is a possibility. The β risk (the probability of committing a type II error) was 0·69 for intestinal recovery and 0·59 for duration of hospital stay; the risk was high for both variables on account of their wide range of values. We totally agree with the points made by Mr Saklani, except his comment that long-course neoadjuvant therapy may make surgery more tedious. Our experience indicates that this is not the case. In reply to the questions raised by Mr Chiu, anastomoses in all patients in both groups were performed using the double-stapling technique with circular staplers. Sectioning of the rectum was carried out with a linear stapler in the open group and with several (two to four) linear endostaplers in the laparoscopic group. We used the handsewing technique only when a coloanal anastomosis was required owing to the low position of the tumour; this occurred in 17 per cent of patients in the open group and 16 per cent in the laparoscopic group. We have no data on the learning curves of laparoscopic anterior resection and abdominoperineal excision, but believe it would be at least 35–40 procedures. Copyright © 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) Copyright © 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
TI - Authors' reply: Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer (Br J Surg 2009; 96: 982–989)
JO - British Journal of Surgery
DO - 10.1002/bjs.6929
DA - 2009-11-13
UR - https://www.deepdyve.com/lp/oxford-university-press/authors-reply-randomized-clinical-trial-comparing-laparoscopic-and-CR1QvUfdMi
SP - 1496
EP - 1496
VL - 96
IS - 12
DP - DeepDyve
ER -