Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial.

INTRODUCTION: Low-pressure pneumoperitoneum (LLP) in laparoscopy colorectal surgery (CS) has resulted in reduced hospital stay and lower analgesic consumption. Microsurgery (MS) in CS is a technique that has a significant impact with respect to postoperative pain. The combination of MS plus LLP, known as low-impact laparoscopy (LIL), has never been applied in CS. Therefore, this trial will assess the efficacy of LLP plus MS versus LLP alone in terms of decreasing postoperative pain 24 h after surgery, without taking opioids. METHOD: PAROS II will be a prospective, multicentre, outcome assessor-blinded, randomised controlled phase III clinical trial that compares LLP plus MS versus LLP alone in patients undergoing laparoscopic surgery for colonic or upper rectal cancer or benign pathology. The primary outcome will be the number of patients with postoperative pain 24 h after the surgery, as defined by a visual analogue scale rating ≤3 and without taking opioids. Overall, PAROS II aims to recruit 148 patients for 50% of patients to reach the primary outcome in the LLP plus MS arm, with 80% power and an 5% alpha risk. CONCLUSION: The PAROS II trial will be the first phase III trial to investigate the impact of LIL, including LLP plus MS, in laparoscopic CS. The results may improve the postoperative recovery experience and decrease opioid consumption after laparoscopic CS.

Laparoscopic surgery for rectal cancer: preoperative radiochemotherapy versus surgery alone.

BACKGROUND: A few studies have suggested advantages of laparoscopic surgery for rectal cancer. However, the role of laparoscopy has not been clearly defined specifically in cases after neoadjuvant radiochemotherapy. This study aimed to assess the impact of preoperative radiotherapy on the feasibility of laparoscopic rectal excision with sphincter preservation for rectal cancer. METHODS: From 1999 to 2010, the authors considered all patients treated by laparoscopic rectal excision with sphincter preservation for rectal cancer. Patients treated by long-course preoperative radiochemotherapy (45 Gy during 5 weeks) were compared with those treated by surgery alone. The end points of the study were mortality, conversion, and overall and surgical morbidity. RESULTS: Among 422 patients treated by laparoscopic conservative rectal excision, 292 received preoperative radiotherapy, and 130 had surgery alone. The two groups were similar in sex, age, body mass index, and American Society of Anesthesiologists (ASA) score. The mortality rate was 0.3% in the radiotherapy group and 0.8% in the surgical group (P = 0.52). The two groups did not differ in terms of conversion (19 vs. 15%; P = 0.39), overall morbidity (37 vs. 29%; P = 0.14), surgical morbidity (20 vs. 18%; P = 0.60), or anastomotic leakage (13 vs. 11%; P = 0.54). Multivariate analysis showed male gender and synchronous metastasis as independent factors of surgical morbidity. The independent factors of conversion were male gender, obesity, tumor stage, and type of anastomosis. Preoperative radiotherapy influenced neither conversion nor surgical morbidity. CONCLUSION: Long-course radiochemotherapy does not have an impact on the feasibility or short-term outcome of laparoscopic conservative rectal excision for rectal cancer.