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

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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).

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Funding

This study was funded by the Korean Society of Endoscopic and Laparoscopic Surgeons’ research grant (Grant Number D2011-49).

Author information

Author notes

  1. Jinkwon Lee

    Present address: Department of Surgery, Changwon Gyeongsang National University Hospital, Gyeongsang National University, Changwon, Korea

Authors and Affiliations

  1. Department of Surgery, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea

    Byung Mo Kang

  2. Department of Surgery, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea

    Hyung Jin Kim & Bong-Hyeon Kye

  3. Department of Surgery, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Daejeon, Korea

    Sang Chul Lee

  4. Department of Surgery, Kyung Hee Medical Center, Kyung Hee University School of Medicine, Seoul, Korea

    Kil Yeon Lee & Sun Jin Park

  5. Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea

    Suk-Hwan Lee

  6. Department of Surgery, Hallym Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea

    Sang Woo Lim

  7. Department of Surgery, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea

    Yoon Suk Lee & Ji Hoon Kim

  8. Department of Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul, 137-701, Korea

    Jinkwon Lee, Min Ki Kim & Jun-Gi Kim

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  1. Byung Mo Kang
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Corresponding author

Correspondence to Jun-Gi Kim.

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Disclosures

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, and Jun-Gi Kim have no conflicts of interest or financial ties to disclose.

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Kang, B.M., Kim, H.J., Kye, BH. et al. Multicenter, randomized single-port versus multiport laparoscopic surgery (SIMPLE) trial in colon cancer: an interim analysis. Surg Endosc 32, 1540–1549 (2018). https://doi.org/10.1007/s00464-017-5842-0

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