Fast-track Perioperative Program for Laparoscopic Colorectal Surgery
The Impact of Fast-track Perioperative Program on the Clinical and Immunological Outcomes After Laparoscopic Colorectal Surgery in Hong Kong Chinese Patients: A Prospective Randomized Trial
Background:
Laparoscopic colorectal surgery has been shown by randomized trials to be associated with better short-term clinical outcomes when compared with open surgery. However, in a traditional perioperative care setting, the reduction in hospital stay following laparoscopic surgery in these trials was modest. Fast-track perioperative programs have been introduced in the West to optimize perioperative factors to reduce the physiological/psychological stress of open colorectal surgery. However, few studies have evaluated the impact of fast-track programs on the outcomes after laparoscopic colorectal surgery.
Objective:
To compare the clinical and immunological outcomes of Hong Kong Chinese patients undergoing laparoscopic surgery for colorectal cancer with a "traditional" vs. a "fast-track" perioperative program.
Design:
Prospective randomized trial.
Subjects:
One hundred and twenty-eight consecutive patients undergoing elective laparoscopic resection of non-metastatic colonic and upper rectal cancer will be recruited.
Interventions:
Patients will be randomized to a "traditional" or a "fast-track" perioperative program.
Outcome measures:
Primary outcome: total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery. Secondary outcomes: immunological parameters (including systemic cytokine response and cell-mediated immune function), morbidity and mortality, quality of life, and medical costs.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
-
Hong Kong, Chine
- Prince of Wales Hospital, the Chinese University of Hong Kong
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion criteria:
- Consecutive patients undergoing elective laparoscopic resection of colonic and upper rectal cancer,
- Age of patients between 18 and 75 years
- Patients with American Society of Anesthesiologists grading I-II
- Patients with no severe physical disability
- Patients who require no assistance with the activities of daily living
- Informed consent available
Exclusion criteria:
- Patients undergoing laparoscopic low anterior resection with total mesorectal excision, abdominoperineal resection, or total/proctocolectomy
- Patients with planned stoma creation
- Patients undergoing emergency surgery
- Patients with known metastatic disease
- Patients with previous history of abdominal surgery
- Patients with known immunological dysfunction
- Patients who are taking steroids or immunosuppressive agents
- Patients with chronic pain syndrome
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Fast-track perioperative program
|
Preoperative counseling, no preoperative fasting, short-acting anesthetics, continuous infiltration of wound with local anesthetic agent, non-opioid pain management, the use of chewing gum, and early postoperative feeding and mobilization
|
|
Comparateur actif: Traditional perioperative program
|
Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Duration of hospital stay
Délai: Up to 1 month
|
Total postoperative hospital stay, including hospital stay of patients who are readmitted within 30 days after surgery.
|
Up to 1 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Coûts médicaux directs/indirects et coûts économiques extra-hospitaliers
Délai: Jusqu'à 1 mois
|
Jusqu'à 1 mois
|
|
|
Taux de réadmission
Délai: Jusqu'à 1 mois
|
Jusqu'à 1 mois
|
|
|
Pain scores
Délai: Up to 1 week
|
Pain scores on visual analogue scale (from 0 which implies no pain at all, to 100 which implies the worst pain imaginable)
|
Up to 1 week
|
|
Morbidity and mortality
Délai: Up to 1 month
|
Up to 1 month
|
|
|
Quality of life
Délai: Up to 1 month
|
Measured by SF-36, EORTC QLQ-C30 and QLQ-CR38 questionnaires
|
Up to 1 month
|
|
Systemic cytokine responses
Délai: Up to 1 week
|
Blood levels of IL-1β, IL-6, and C-reactive protein
|
Up to 1 week
|
|
Lymphocyte subsets
Délai: Up to 1 week
|
Using flow cytometer to determine lymphocyte subsets and NK cell counts (cells/uL)
|
Up to 1 week
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CRE-2008.552-T
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