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Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial

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Abstract

Background

Surgical management of left colonic cancer presenting as an acute obstruction remains controversial and still is associated with high mortality and morbidity rates. Recently, self-expandable metallic stents (SEMS) have been used as a bridge to surgery in an attempt to decompress the colon and then allow elective one-stage surgical resection without stoma placement. This study aimed to compare the outcomes of emergency surgery alone with emergency placement of colonic SEMS as a bridge to surgery in terms of efficiency and reduction of the stoma placement rate.

Methods

A multicenter prospective, randomized, controlled trial was conducted according to the consolidated standards of reporting trials (CONSORT) Statement criteria. Patients eligible for the study were randomized to either emergency surgery or emergency SEMS as a bridge to surgery. The primary outcome was the need for a stoma (temporary or permanent) for any reason. The secondary end points were mortality, morbidity, and length of hospital stay.

Results

Nine centers participated in the trial. Among the 70 patients eligible for the study, 60 were randomized and included for the final analysis, 30 patients in each group. Seven patients were randomized but did not fulfill the entry requirements, whereas three further eligible patients were not randomized for various reasons. Concerning the primary outcome, 17 patients in the surgery group sustained a stoma placement versus 13 patients in the SEMS group (p = 0.30). No statistically significant difference was noted concerning the secondary outcomes. A total of 16 attempts at SEMS placement (53.3%) were technical failures. Two colonic perforations directly related to the stent placement procedure occurred among the 30 randomized patients and 1 perforation occurred among the nonrandomized patients, leading to premature closure of inclusions in the study before the expected number of 80 patients was reached.

Conclusion

This randomized trial failed to demonstrate that emergency preoperative SEMS for patients presenting with acute left-sided malignant colonic obstruction could significantly decrease the need for stoma placement.

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Acknowledgments

The metallic stent devices were provided free of charge by BARD France SAS. Financial support was provided by the hospital clinical research program (PHRC), Montpellier University Hospital and by the A.F.S.S.A.P.S. (Agence Française de Sécurité sanitaire des produits de santé). The study was performed by the cooperation of the following investigators: D. Collet (Digestive Surgery Unit), J. Drouillard (Medical Imaging Unit), Bordeaux University Hospital, France; F. Michot, O. Foulatier (Digestive Surgery Unit), E. Lerebours, P. Ducrotte, M. Antonietti, E. Bensoussan (Gastroenterology Unit), Rouen University Hospital, France; J. P. Triboulet, C. Mariette (Digestive Surgery Unit), O. Ernst (Digestive and Endocrine Imaging Unit), Lille University Hospital, France; B. Suc, F. Muscari (Digestive Surgery Unit), P. Otal (Medical Imaging Unit), Toulouse University Hospital, France; B. Meunier (Digestive Surgery Unit), S. Manfredi (Gastroenterology Unit) Rennes University Hospital, France; J. P. Arnaud (Digestive Surgery Unit), C. Aubé, C. Ridereau (Medical Imaging Unit), Angers University Hospital, France; C. Letoublon, E. Desroche (Digestive Surgery Unit), C. Sengel (Medical Imaging Unit), Grenoble University Hospital, France; J. M. Hay, S. Msika (Digestive Surgery Unit), M. Levesque (Medical Imaging Unit), University Hospital Louis Mourrier, Colombes, France; P. Puche, P. M. Blanc, H. Bouyabrine (Digestive Surgery Unit), B. Gallix (Medical Imaging Unit), A. Mouraret, C. Lacombe (Clinical Research Associates), Montpellier University Hospital. The protocol has been registered in ClinicalTrials.gov with the identifier number NCT00514332.

Disclosures

Isabelle A. Pirlet, Karem Slim, Fabrice Kwiatkowski, Francis Michot, and Bertrand L. Millat have no conflicts of interest or financial ties to disclose.

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Authors and Affiliations

  1. Digestive Surgery Unit, Hôpital Saint Eloi, Montpellier University Hospital, Montpellier Cedex 5, France

    Isabelle A. Pirlet & Bertrand L. Millat

  2. Digestive Surgery Unit, CHU Estaing, Clermont-Ferrand University Hospital, Clermont-Ferrand, France

    Karem Slim

  3. Department of Statistics, Centre Jean Perrin, Clermont-Ferrand, France

    Fabrice Kwiatkowski

  4. Digestive Surgery Unit, Hôpital Charles Nicolle, Rouen University Hospital, Rouen, France

    Francis Michot

Authors
  1. Isabelle A. Pirlet
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  2. Karem Slim
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  3. Fabrice Kwiatkowski
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  4. Francis Michot
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  5. Bertrand L. Millat
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Correspondence to Bertrand L. Millat.

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Pirlet, I.A., Slim, K., Kwiatkowski, F. et al. Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc 25, 1814–1821 (2011). https://doi.org/10.1007/s00464-010-1471-6

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  • DOI: https://doi.org/10.1007/s00464-010-1471-6

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