title: The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  To achieve an adequate visual working field during laparoscopic colorectal surgery without disturbance of the small intestine, patients are positioned in the Trendelenburg position. This position results in hemodynamic changes that may increase the risk of cardiopulmonary complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was introduced as an alternative to the Trendelenburg position during laparoscopic surgery. The objective of this trial is to study the impact of the use of an intraoperative retractor sponge on the duration of the hospital stay and risk of perioperative complications in patients undergoing laparoscopic surgery for colorectal cancer.
  
  
  METHODS
  The SPONGE trial is a monocenter study and follows the cohort multiple randomized controlled trial (cmRCT) design. It will be conducted within a multicenter prospective observational cohort of colorectal cancer patients of all stages, for whom longitudinal clinical data and patient-reported outcomes are collected. Patients within the cohort, who will undergo laparoscopic surgery for distal colon or rectal cancer, are eligible for inclusion and form a subcohort. From this subcohort, a 1:1 random sample will be offered to undergo surgery with the use of the retractor sponge. Patients from the subcohort who are not selected will undergo standard treatment, that is, surgery in the Trendelenburg position. The primary endpoint is the duration of the postoperative hospital stay. Secondary outcomes are duration of surgery; intraoperative blood loss and fluid balance; and postoperative body temperature, oxygenation and complications. Both arms require 94 patients.
  
  
  CONCLUSIONS
  This study is the first randomized controlled trial to evaluate the effect of sponge-assisted laparoscopic colorectal surgery in comparison with standard Trendelenburg position on hospital stay and peri- and postoperative complications. Results of this study will also be relevant for other surgical procedures in the pelvic region. The present study is the second randomized controlled trial according to the cmRCT design, which is embedded within our colorectal cancer cohort.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02574013 . Registered 27 September 2015.
authors.affiliation: Department of Radiotherapy, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, 3508 GA, The Netherlands. a.m.couwenberg-2@umcutrecht.nl.
authors.forename: Alice M
authors.initials: AM
authors.lastname: Couwenberg
authors.affiliation: Department of Radiotherapy, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, 3508 GA, The Netherlands.
authors.forename: Maarten J P
authors.initials: MJ
authors.lastname: Burbach
authors.affiliation: Department of Surgery, St. Antonius Hospital, Koekoekslaan 1, Nieuwegein, 3430 EM, The Netherlands.
authors.forename: Anke B
authors.initials: AB
authors.lastname: Smits
authors.affiliation: Department of Radiotherapy, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, 3508 GA, The Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Van Vulpen
authors.affiliation: Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, 3508 GA, The Netherlands.
authors.forename: Wilhemina M U
authors.initials: WM
authors.lastname: Van Grevenstein
authors.affiliation: Department of Anesthesiology, St. Antonius Hospital, Koekoekslaan 1, Nieuwegein, 3430 EM, The Netherlands.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Noordzij
authors.affiliation: Imaging Division, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, 3508 GA, The Netherlands.
authors.forename: Helena M
authors.initials: HM
authors.lastname: Verkooijen
mesh_terms: D002985:Clinical Protocols; D003082:Colectomy / Q000295:instrumentation*; D015179:Colorectal Neoplasms / Q000473:pathology / Q000601:surgery*; D004867:Equipment Design; D018475:Head-Down Tilt; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000295:instrumentation*; D007902:Length of Stay; D009426:Netherlands; D056888:Patient Positioning; D011183:Postoperative Complications / Q000209:etiology* / Q000628:therapy; D012107:Research Design; D012307:Risk Factors; D015503:Surgical Sponges; D013997:Time Factors; D016896:Treatment Outcome
keywords: Colorectal cancer; gastrointestinal surgery; laparoscopic surgery