A randomized controlled trial of single-port versus multi-port laparoscopic distal gastrectomy for gastric cancer
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and Other Interventional Techniques
A randomized controlled trial of single‑port versus multi‑port laparoscopic distal gastrectomy for gastric cancer Takeshi Omori1 · Kazuyoshi Yamamoto1 · Hisashi Hara1 · Naoki Shinno1 · Masaaki Yamamoto1 · Keijirou Sugimura1 · Hiroshi Wada1 · Hidenori Takahashi1 · Masayoshi Yasui1 · Hiroshi Miyata1 · Masayuki Ohue1 · Masahiko Yano1 · Masato Sakon1 Received: 8 June 2020 / Accepted: 27 August 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Objective This prospective randomized trial compared the invasiveness of laparoscopic gastrectomy using a single-port approach with that of a conventional multi-port approach in the treatment of gastric cancer. Summary Background Data The benefit of single-port laparoscopic gastrectomy (SLG) over multi-port laparoscopic gastrectomy (MLG) has yet to be confirmed in a well-designed study. Methods One hundred and one patients who were scheduled to undergo laparoscopic distal gastrectomy for histologically confirmed clinical stage I gastric cancer between April 2016 and September 2018 were randomly allocated to SLG (n = 50) or MLG (n = 51). The primary endpoints were the postoperative visual analog scale pain scores. Secondary endpoints were frequency of use of analgesia, short-term outcomes, such as operating time, intraoperative blood loss, inflammatory reactions, postoperative morbidity, and 90-day mortality. Results The postoperative pain score was significantly lower in the SLG group than in the MLG group (p 30; previous or other concomitant cancer; a renal, hepatic, or metabolic disorder (e.g., severe diabetes); cardiac disease; and a history of gastrectomy.
Study endpoints The primary study endpoint was the visual analog scale (VAS) pain score at rest on postoperative days (PODs) 1. The secondary endpoints were VAS pain score 6 h after the operation and on postoperative days (PODs) 2–7, frequency of administration of additional analgesics, and duration of use of analgesia, the perioperative outcomes, including operating time, estimated blood loss, postoperative mortality and morbidity, postoperative inflammatory reaction, postoperative time to flatus, postoperative time to resuming oral intake, and postoperative hospital stay.
Randomization Using an internet randomization module, the subjects were randomly allocated to an SLG group or an MLG group in a 1:1 ratio using a minimization method with a random component to balance the arms based on sex, age, and body mass index. The patients were enrolled to the study by the responsible surgeon before surgery. Patients and all investigators were unmasked to treatment assignment. Laparoscopic distal gastrectomy was performed using a single-port or multi-port approach by the same team of surgeons (TO, KY, YY).
Data collection The data were collected prospectively and recorded in a computer database at our hospital. In the SLG group, conversion to MLG was defined as addition of any port to the abdominal wall to complete the procedure. An open conversion was
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