Multicenter, randomized single-port versus multiport laparoscopic surgery (SIMPLE) trial in colon cancer: an interim analysis View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-03

AUTHORS

Byung Mo Kang, Hyung Jin Kim, Bong-Hyeon Kye, Sang Chul Lee, Kil Yeon Lee, Sun Jin Park, Suk-Hwan Lee, Sang Woo Lim, Yoon Suk Lee, Ji Hoon Kim, Jinkwon Lee, Min Ki Kim, Jun-Gi Kim

ABSTRACT

BACKGROUND: Single-port laparoscopic surgery (SPLS) was recently introduced as an innovative minimally invasive surgery method. Retrospective studies have revealed the safety and feasibility of SPLS for colon cancer treatment. However, no prospective randomized trials have been performed. The multicenter, randomized SIMPLE (single-port versus multiport laparoscopic surgery) trial aimed to investigate short-term perioperative outcomes of SPLS for colon cancer treatment, compared with multiport laparoscopic surgery (MPLS). METHODS: Between August 2011 and April 2014, a total of 194 patients with colon cancer were recruited from seven hospitals in Korea. Patients were randomly allocated into the SPLS group (n = 99) or MPLS group (n = 95). The primary endpoint was postoperative complications. Operative, postoperative, and pathologic outcomes were analyzed after 50% of the patient study population had been recruited. RESULTS: The patients' demographic characteristics, operative times, estimated blood volume losses, numbers of harvested lymph nodes, and lengths of both resection margins were not significantly different between groups. In the SPLS group, the rates of conversion to MPLS and open surgery were 12.9 and 2.2%, respectively. Postoperative complications occurred in 10.8% of the SPLS, and 12.5% of the MPLS patients (p = 0.714). Times to functional recovery, pain scores, and amounts of analgesia were similar between groups. CONCLUSION: The results of this interim analysis suggested that SPLS is technically safe and appropriate when used for radical resection of colon cancer. (ClinicalTrials.gov Identifier: NCT01480128). More... »

PAGES

1540-1549

References to SciGraph publications

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URI

http://scigraph.springernature.com/pub.10.1007/s00464-017-5842-0

DOI

http://dx.doi.org/10.1007/s00464-017-5842-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1091806597

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28916955


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