Surgical Endoscopy

, Volume 32, Issue 3, pp 1540–1549 | Cite as

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

  • 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
Article
  • 121 Downloads

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).

Keywords

Single-port Laparoscopy Colon cancer Short-term outcomes Randomized controlled trial 

Notes

Funding

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

Compliance with ethical standards

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.

Supplementary material

464_2017_5842_MOESM1_ESM.doc (217 kb)
Supplementary material 1 (DOC 217 kb)

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Copyright information

© Springer Science+Business Media, LLC 2017

Authors and Affiliations

  • Byung Mo Kang
    • 1
  • Hyung Jin Kim
    • 2
  • Bong-Hyeon Kye
    • 2
  • Sang Chul Lee
    • 3
  • Kil Yeon Lee
    • 4
  • Sun Jin Park
    • 4
  • Suk-Hwan Lee
    • 5
  • Sang Woo Lim
    • 6
  • Yoon Suk Lee
    • 7
  • Ji Hoon Kim
    • 7
  • Jinkwon Lee
    • 8
    • 9
  • Min Ki Kim
    • 8
  • Jun-Gi Kim
    • 8
  1. 1.Department of Surgery, Chuncheon Sacred Heart HospitalHallym University College of MedicineChuncheonKorea
  2. 2.Department of Surgery, St. Vincent’s Hospital, College of MedicineThe Catholic University of KoreaSuwonKorea
  3. 3.Department of Surgery, Daejeon St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaDaejeonKorea
  4. 4.Department of Surgery, Kyung Hee Medical CenterKyung Hee University School of MedicineSeoulKorea
  5. 5.Department of Surgery, Kyung Hee University Hospital at GangdongKyung Hee University School of MedicineSeoulKorea
  6. 6.Department of Surgery, Hallym Sacred Heart HospitalHallym University College of MedicineAnyangKorea
  7. 7.Department of Surgery, Incheon St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaIncheonKorea
  8. 8.Department of Surgery, Seoul St. Mary’s Hospital, College of MedicineThe Catholic University of KoreaSeoulKorea
  9. 9.Department of Surgery, Changwon Gyeongsang National University HospitalGyeongsang National UniversityChangwonKorea

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