Long-term survival after laparoscopic versus open resection for colorectal liver metastases.

LBA3516 Background: Despite the recent worldwide dissemination of laparoscopic liver surgery, the long-term oncologic outcomes of laparoscopic and open liver surgery have never been compared in a randomized controlled trial. Methods: OSLO-COMET was a randomized controlled trial recruiting patients from Oslo University Hospital, Oslo, Norway. The primary outcome of the trial was postoperative morbidity within 30 days. Patients with radically resectable liver metastases from colorectal cancer were randomly assigned to undergo laparoscopic or open parenchyma-sparing liver resection. Overall survival was a predefined secondary endpoint for the trial. Survival data for the treatment arms will be compared using a log-rank test and Kaplan-Meier plots. Results: From February 2012 to January 2016 a total of 294 patients were screened and 280 (95%) patients were randomized to laparoscopic (n = 133) or open (n = 147) surgery. The primary endpoint demonstrated a significant reduction in morbidity from 31% in the open group to 19% in the laparoscopic group. Other secondary outcomes demonstrated no difference between the groups, including the rate of R0 resection and the width of resection margins, while laparoscopic surgery was found to be cost-effective. Patients received perioperative chemotherapy following Norwegian guidelines. The final patient was operated on Feb 28, 2016, and a survival analysis was performed on March 14, 2019, with a minimum of 36 months follow-up. By ITT analysis (n = 280), median overall survival (OS) was 80 months (95% CI 52-108) in the laparoscopic surgery group and 81 months (95% CI 42-120) in the open surgery group, p=0.91. By modified ITT, (only patients that had R0/R1 resection), median recurrence free survival (RFS) was 19 months (10-27) in the laparoscopic group and 16 months (11-21) in the open group, p = 0.96. Conclusions: Laparoscopic surgery in patients with colorectal liver metastases was associated with rates of OS and RFS similar to open surgery. Clinical trial information: NCT01516710.

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Randomized Controlled Trial Comparing Open versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The Capd I Trial

Peritoneal Dialysis International ◽

10.3747/pdi.2017.00023 ◽

2017 ◽

Vol 38 (2) ◽

pp. 104-112 ◽

Cited By ~ 12

Author(s):

Jorinde H.H. van Laanen ◽

Tom Cornelis ◽

Barend M. Mees ◽

Elisabeth J. Litjens ◽

Magda M. van Loon ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Peritoneal Dialysis ◽

Open Surgery ◽

Clinical Success ◽

Controlled Trial ◽

Laparoscopic Group ◽

Randomized Controlled ◽

Surgery Group ◽

Fixation Techniques ◽

Open Versus

Objective To determine the best operation technique, open versus laparoscopic, for insertion of a peritoneal dialysis (PD) catheter with regard to clinical success. Clinical success was defined as an adequate function of the catheter 2 – 4 weeks after insertion. Methods All patients with end-stage renal disease who were suitable for PD and gave informed consent were randomized for either open surgery or laparoscopic surgery. A previous laparotomy was not considered an exclusion criterion. Laparoscopic placement had the advantage of pre-peritoneal tunneling, the possibility for adhesiolysis, and placement of the catheter under direct vision. Catheter fixation techniques, omentopexy, or other adjunct procedures were not performed. Other measured parameters were in-hospital morbidity and mortality and post-operative infections. Results Between 2010 and 2016, 95 patients were randomized to this study protocol. After exclusion of 5 patients for various reasons, 44 patients received an open procedure and 46 patients a laparoscopic procedure. Gender, age, body mass index (BMI), hypertension, current hemodialysis, severe heart failure, and previous an abdominal operation were not significantly different between the groups. However, in the open surgery group, fewer patients had a previous median laparotomy compared with the laparoscopic group (6 vs 16 patients; p = 0.027). There was no statistically significant difference in mean operation time (36 ± 24 vs 38 ± 15 minutes) and hospital stay (2.1 ± 2.7 vs 3.1 ± 7.3 days) between the groups. In the open surgery group 77% of the patients had an adequate functioning catheter 2 – 4 weeks after insertion compared with 70% of patients in the laparoscopic group ( p = not significant [NS]). In the open surgery group there was 1 post- operative death (2%) compared with none in the laparoscopic group ( p = NS). The morbidity in both groups was low and not significantly different. In the open surgery group, 2 patients had an exit-site infection and 1 patient had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. Conclusion This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome.

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