- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01762254
Prospective Randomized Trial of Incisionless Versus Conventional Laparoscopic Colectomy for Left-sided Colonic Tumors
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
For the left-sided colorectal cancer, the investigators performed colectomy with primary anatomosis. Currently the investigators have two methods of minimal access approach to the abdominal cavity in order to complete this operation:
- Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
- Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the Transanal Endoscopic Operation (TEO) device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
These two operations are essentially identical except for the surgical access for the delivery of specimen and insertion of anvil. Laparoscopic colectomy and the use of Transanal Endoscopic Operation(TEO)device have been practiced in the United States and Europe for over 10 years. Large scale studies in the literature have demonstrated the safety and benefits of laparoscopic colectomy for colonic tumors and the oncological outcomes have not shown to be inferior to open approach. With the use of TEO device, the investigators can perform laparoscopic colectomy without abdominal incision for those early left-sided colonic tumors and thus it can eliminate the wound-related complications theoretically. In order to find out which one is a better procedure, the investigators are carrying out a clinical trial to compare the two surgical options in their short-term and long term outcomes.The results of this study may have an impact on the care of similar patients in the future.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Hong Kong, Chine
- Department of Surgery, Pamela Youde Nethersole Eastern Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
patients >18 years old and diagnosed to have operable left-sided colorectal cancers distal to the splenic flexure and proximal to the upper rectum were potential candidates.
Exclusion Criteria:
- Patient who did not give informed consent;
- Patient who were considered unfit for operative treatment;
- Patient presented as acute surgical emergencies, including intestinal obstruction, peritonitis, or pericolic abscess, etc.;
- Patients with metastatic diseases on preoperative work up;
- Patient with synchronous tumours or polyps which necessitate extended or additional resection;
- Patients with large bulky tumor as demonstrated on preoperative colonoscopy or computed tomography showing serosal involvement or invasion to contiguous organs.
- Patients with anal stenosis that precluded the insertion of TEO device
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: incisionless laparoscopic colectomy
incisionless laparoscopic colectomy: Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy.
Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
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Arm 1:Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy.
Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
|
Comparateur actif: conventional laparoscopic colectomy
conventional laparoscopic colectomy: The operation is completed by laparoscopic instruments using video laparoscopy.
At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler.
Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
|
Arm 2: Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy.
At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler.
Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
pain score
Délai: average of 1 week
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participants will be followed for the pain score during the duration of hospital stay, an expected average of 1 week
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average of 1 week
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
wound complication
Délai: up to 30 days after the operation
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The patient will be followed for up to 30 days after the operation or till occurrence of event
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up to 30 days after the operation
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
intraoperative blood loss
Délai: From the start of operation till operation finished
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From the start of operation till operation finished
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From the start of operation till operation finished
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operative time
Délai: From the start of operation till operation finished
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From the start of operation till operation finished
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From the start of operation till operation finished
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length of hospital stay
Délai: From the date after operation to date of discharge,an expected average of within 1 week
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From the date after operation to date of discharge,an expected average of within 1 week
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From the date after operation to date of discharge,an expected average of within 1 week
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yui Shan Cheung, FRACS, Department of Surgery, Pamela Youde Nethersole Eastern Hospital
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
- HKEC-2009-023
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Essais cliniques sur incisionless laparoscopic colectomy
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City Clinical Hospital No.1 named after N.I. PirogovPirogov Russian National Research Medical UniversityRecrutementHernie incisionnelle de la ligne médiane de l'abdomenFédération Russe