Rechercher
image du produit
Lancet Oncology, The

S'abonner

Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial - 26/09/12

Doi : 10.1016/S1470-2045(10)70131-5 
Sung-Bum Kang, MD a, Ji Won Park, MD e, Seung-Yong Jeong, MD g, Byung Ho Nam, PhD f, Hyo Seong Choi, MD e, Duck-Woo Kim, MD a, Seok-Byung Lim, MD h, Taek-Gu Lee, MD a, Dae Yong Kim, MD e, Jae-Sung Kim, ProfMD b, Hee Jin Chang, MD e, Hye-Seung Lee, MD c, Sun Young Kim, MD e, Kyung Hae Jung, MD i, Yong Sang Hong, MD i, Jee Hyun Kim, MD d, Dae Kyung Sohn, MD e, Dae-Hyun Kim, MD e, Jae Hwan Oh, DrMD e, ⁎
a Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea 
b Department of Radiation Oncology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea 
c Department of Pathology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea 
d Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea 
e Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea 
f Center for Clinical Trials, Research Institute and Hospital, National Cancer Center, Goyang, South Korea 
g Division of Colorectal Surgery, Department of Surgery, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea 
h Department of Colon and Rectal Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea 
i Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea 

* Correspondence to: Dr Jae Hwan Oh, Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 410-769, South Korea

Summary

Background

The safety and short-term efficacy of laparoscopic surgery for rectal cancer after preoperative chemoradiotherapy has not been demonstrated. The aim of the randomised Comparison of Open versus laparoscopic surgery for mid and low REctal cancer After Neoadjuvant chemoradiotherapy (COREAN) trial was to compare open surgery with laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy.

Methods

Between April 4, 2006, and Aug 26, 2009, patients with cT3N0–2 mid or low rectal cancer without distant metastasis after preoperative chemoradiotherapy were enrolled at three tertiary-referral hospitals. Patients were randomised 1:1 to receive either open surgery (n=170) or laparoscopic surgery (n=170), stratified according to sex and preoperative chemotherapy regimen. Short-term outcomes assessed were involvement of the circumferential resection margin, macroscopic quality of the total mesorectal excision specimen, number of harvested lymph nodes, recovery of bowel function, perioperative morbidity, postoperative pain, and quality of life. Analyses were based on the intention-to-treat population. Patients continue to be followed up for the primary outcome (3-year disease-free survival). This study is registered with ClinicalTrials.gov, number NCT00470951.

Findings

Two patients (1·2%) in the laparoscopic group were converted to open surgery, but were included in the laparoscopic group for analyses. Estimated blood loss was less in the laparoscopic group than in the open group (median 217·5 mL [150·0–400·0] in the open group vs 200·0 mL [100·0–300·0] in the laparoscopic group, p=0·006), although surgery time was longer in the laparoscopic group (mean 244·9 min [SD 75·4] vs 197·0 min [62·9], p<0·0001). Involvement of the circumferential resection margin, macroscopic quality of the total mesorectal excision specimen, number of harvested lymph nodes, and perioperative morbidity did not differ between the two groups. The laparoscopic surgery group showed earlier recovery of bowel function than the open surgery group (time to pass first flatus, median 38·5 h [23·0–53·0] vs 60·0 h [43·0–73·0], p<0·0001; time to resume a normal diet, 85·0 h [66·0–95·0] vs 93·0 h [86·0–121·0], p<0·0001; time to first defecation, 96·5 h [70·0–125·0] vs 123 h [94·0–156·0], p<0·0001). The total amount of morphine used was less in the laparoscopic group than in the open group (median 107·2 mg [80·0–150·0] vs 156·9 mg [117·0–185·2], p<0·0001). 3 months after proctectomy or ileostomy takedown, the laparoscopic group showed better physical functioning score than the open group (0·501 [n=122] vs −4·970 [n=128], p=0·0073), less fatigue (−5·659 [n=122] vs 0·098 [n=129], p=0·0206), and fewer micturition (−2·583 [n=122] vs 4·725 [n=129], p=0·0002), gastrointestinal (−0·400 [n=122] vs 4·331 [n=129], p=0·0102), and defecation problems (0·535 [n=103] vs 5·327 [n=99], p=0·0184) in repeated measures analysis of covariance, adjusted for baseline values.

Interpretation

Laparoscopic surgery after preoperative chemoradiotherapy for mid or low rectal cancer is safe and has short-term benefits compared with open surgery; the quality of oncological resection was equivalent.

Funding

The National Cancer Center, South Korea.

Le texte complet de cet article est disponible en PDF.

Plan


© 2010  Elsevier Ltd. Tous droits réservés.
Ajouter à ma bibliothèque Retirer de ma bibliothèque Imprimer
Export

    Export citations

  • Fichier

    •

  • Contenu

    •

Vol 11 - N° 7

P. 637-645 - juillet 2010 Retour au numéro
Article précédent Article précédent
  • Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials
  • Ilke Sipahi, Sara M Debanne, Douglas Y Rowland, Daniel I Simon, James C Fang
| Article suivant Article suivant
  • Size of sentinel-node metastasis and chances of non-sentinel-node involvement and survival in early stage vulvar cancer: results from GROINSS-V, a multicentre observational study
  • Maaike H Oonk, Bettien M van Hemel, Harry Hollema, Joanne A de Hullu, Anca C Ansink, Ignace Vergote, René H Verheijen, Angelo Maggioni, Katja N Gaarenstroom, Peter J Baldwin, Eleonora B van Dorst, Jacobus van der Velden, Ralph H Hermans, Hans W van der Putten, Pierre Drouin, Ingo B Runnebaum, Wim J Sluiter, Ate G van der Zee

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

Accès rapides

Mon compte

Aide & support

Plateformes Elsevier Masson

Déclaration CNIL

EM-CONSULTE.COM est déclaré à la CNIL, déclaration n° 1286925.

En application de la loi nº78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés, vous disposez des droits d'opposition (art.26 de la loi), d'accès (art.34 à 38 de la loi), et de rectification (art.36 de la loi) des données vous concernant. Ainsi, vous pouvez exiger que soient rectifiées, complétées, clarifiées, mises à jour ou effacées les informations vous concernant qui sont inexactes, incomplètes, équivoques, périmées ou dont la collecte ou l'utilisation ou la conservation est interdite.
Les informations personnelles concernant les visiteurs de notre site, y compris leur identité, sont confidentielles.
Le responsable du site s'engage sur l'honneur à respecter les conditions légales de confidentialité applicables en France et à ne pas divulguer ces informations à des tiers.

Tout le contenu de ce site: Copyright © 2024 Elsevier, ses concédants de licence et ses contributeurs. Tout les droits sont réservés, y compris ceux relatifs à l'exploration de textes et de données, a la formation en IA et aux technologies similaires. Pour tout contenu en libre accès, les conditions de licence Creative Commons s'appliquent.