Open Access Highly Accessed Study protocol

Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial)

Jan Wind1*, Jan Hofland2, Benedikt Preckel2, Markus W Hollmann2, Patrick MM Bossuyt3, Dirk J Gouma1, Mark I van Berge Henegouwen1, Jan Willem Fuhring1, Cornelis HC Dejong4, Ronald M van Dam4, Miguel A Cuesta5, Astrid Noordhuis5, Dick de Jong5, Edith van Zalingen6, Alexander F Engel7, T Hauwy Goei7, I Erica de Stoppelaar8, Willem F van Tets9, Bart A van Wagensveld9, Annemiek Swart9, Maarten JLJ van den Elsen10, Michael F Gerhards11, Laurens Th de Wit11, Muriel AM Siepel12, Anna AW van Geloven13, Jan-Willem Juttmann13, Wilfred Clevers14 and Willem A Bemelman1

Author Affiliations

1 Department of Surgery, Academic Medical Center Amsterdam, The Netherlands

2 Department of Anesthesiology, Academic Medical Center Amsterdam, The Netherlands

3 Department of clinical epidemiology and biostatistics, Academic Medical Center Amsterdam, The Netherlands

4 Department of Surgery, University Hospital Maastricht, The Netherlands

5 Department of Surgery, VU Medical Center Amsterdam, The Netherlands

6 Department of Anesthesiology, VU Medical Center Amsterdam, The Netherlands

7 Department of Surgery, Zaans Medical Center Zaandam, The Netherlands

8 Department of Anesthesiology, Zaans Medical Center Zaandam, The Netherlands

9 Department of Surgery, Sint Lucas Andreas Hospital Amsterdam, The Netherlands

10 Department of Anesthesiology, Sint Lucas Andreas Hospital Amsterdam, The Netherlands

11 Department of Surgery, Onze Lieve Vrouwen Gasthuis Amsterdam, The Netherlands

12 Department of Anesthesiology, Onze Lieve Vrouwen Gasthuis Amsterdam, The Netherlands

13 Department of Surgery, Hilversum Hospital, The Netherlands

14 Department of Anesthesiology, Hilversum Hospital, The Netherlands

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BMC Surgery 2006, 6:16  doi:10.1186/1471-2482-6-16

Published: 29 November 2006

Abstract

Background

Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay.

The randomized controlled multicenter LAFA-trial (LAparoscopy and/or FAst track multimodal management versus standard care) was conceived to determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease.

Methods/design

The LAFA-trial is a double blinded, multicenter trial with a 2 × 2 balanced factorial design. Patients eligible for segmental colectomy for malignant colorectal disease i.e. right and left colectomy and anterior resection will be randomized to either open or laparoscopic colectomy, and to either standard care or the fast track program. This factorial design produces four treatment groups; open colectomy with standard care (a), open colectomy with fast track program (b), laparoscopic colectomy with standard care (c), and laparoscopic surgery with fast track program (d). Primary outcome parameter is postoperative hospital length of stay including readmission within 30 days. Secondary outcome parameters are quality of life two and four weeks after surgery, overall hospital costs, morbidity, patient satisfaction and readmission rate.

Based on a mean postoperative hospital stay of 9 +/- 2.5 days a group size of 400 patients (100 each arm) can reliably detect a minimum difference of 1 day between the four arms (alfa = 0.95, beta = 0.8). With 100 patients in each arm a difference of 10% in subscales of the Short Form 36 (SF-36) questionnaire and social functioning can be detected.

Discussion

The LAFA-trial is a randomized controlled multicenter trial that will provide evidence on the merits of fast track perioperative care and laparoscopic colorectal surgery in patients having segmental colectomy for malignant disease.