Open Access Highly Accessed Study protocol

Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study)

Jeanin E van Hooft1*, Willem A Bemelman2, Ronald Breumelhof3, Peter D Siersema4, Philip M Kruyt5, Klaas van der Linde6, Roeland A Veenendaal7, Marie-Louise Verhulst8, Andreas W Marinelli9, Josephus JGM Gerritsen10, Anne-Marie van Berkel11, Robin Timmer12, Marina JAL Grubben13, Pieter Scholten14, Alfons AM Geraedts15, Bas Oldenburg16, Mirjam AG Sprangers17, Patrick MM Bossuyt18 and Paul Fockens1

Author Affiliations

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

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

3 Department of internal medicine, Diaconessenhuis Hospital, Utrecht, The Netherlands

4 Department of Gastroenterology, Erasmus Medical Center, Rotterdam, The Netherlands

5 Department of Surgery, Gelderse Vallei Hospital, Ede, The Netherlands

6 Department of Gastroenterology, Medical Center Leeuwarden, Leeuwarden, The Netherlands

7 Department of Gastroenterology, Leiden University Medical Center, Leiden, The Netherlands

8 Department of Gastroenterology, Máxima Medical Center, Eindhoven, The Netherlands

9 Department of Surgery, Medical Center Haaglanden, Den Haag, The Netherlands

10 Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands

11 Department of Gastroenterology, Rode Kruis Hospital, Beverwijk, The Netherlands

12 Department of Gastroenterology, St Antonius Hospital, Nieuwegein, The Netherlands

13 Department of Gastroenterology, St Elisabeth Hospital, Tilburg, The Netherlands

14 Department of Gastroenterology, St Lucas Andreas Hospital, Amsterdam, The Netherlands

15 Department of Gastroenterology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

16 Department of Gastroenterology, University Medical Center, Utrecht, The Netherlands

17 Department of Medical Psychology, Academic Medical Center, Amsterdam, The Netherlands

18 Department of Clinical Epidemiology and Bio-statistics, Academic Medical Center, Amsterdam, The Netherlands

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BMC Surgery 2007, 7:12  doi:10.1186/1471-2482-7-12

Published: 3 July 2007

Abstract

Background

Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion.

Methods/design

Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics.

Discussion

The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction.

Trial registration

Current Controlled Trials ISRCTN46462267.