Colon Cancer Clinical Trial
Official title:
Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy.
During the last few years, the laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA) has been proposed as an alternative to laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA) for the treatment of right colon tumors. However, the level of evidence coming from the currently available literature is low, based on the results of a few small and heterogeneous retrospective non-randomized studies. A randomised controlled trial is warranted to challenge these two procedures. The aim of this randomized controlled trial is to assess the outcomes after IIA or EIA after laparoscopic right colectomy for right colon tumors.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | July 30, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient diagnosed with a solitary benign or malignant neoplasm localized in the right colon - Patients aged 18 years or older - Patients who give written informed consent Exclusion Criteria: - acute intestinal obstruction - colon perforation; - liver and/or lung metastases; - multiple primary colonic tumors; - scheduled need for synchronous intra-abdominal surgery; - preoperative evidence of invasion of adjacent structures, as assessed by CT or ultrasonography; - previous ipsilateral colon surgery. |
Country | Name | City | State |
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Italy | Department of Surgical Sciences, University of Torino, AOU Città della Salute e della Scienza | Torino |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Chaves JA, Idoate CP, Fons JB, Oliver MB, Rodríguez NP, Delgado AB, Lizoain JL. [A case-control study of extracorporeal versus intracorporeal anastomosis in patients subjected to right laparoscopic hemicolectomy]. Cir Esp. 2011 Jan;89(1):24-30. doi: 10.10 — View Citation
Fabozzi M, Allieta R, Brachet Contul R, Grivon M, Millo P, Lale-Murix E, Nardi M Jr. Comparison of short- and medium-term results between laparoscopically assisted and totally laparoscopic right hemicolectomy: a case-control study. Surg Endosc. 2010 Sep;2 — View Citation
Grams J, Tong W, Greenstein AJ, Salky B. Comparison of intracorporeal versus extracorporeal anastomosis in laparoscopic-assisted hemicolectomy. Surg Endosc. 2010 Aug;24(8):1886-91. doi: 10.1007/s00464-009-0865-9. Epub 2010 Jan 29. — View Citation
Hanna MH, Hwang GS, Phelan MJ, Bui TL, Carmichael JC, Mills SD, Stamos MJ, Pigazzi A. Laparoscopic right hemicolectomy: short- and long-term outcomes of intracorporeal versus extracorporeal anastomosis. Surg Endosc. 2016 Sep;30(9):3933-42. doi: 10.1007/s0 — View Citation
Hellan M, Anderson C, Pigazzi A. Extracorporeal versus intracorporeal anastomosis for laparoscopic right hemicolectomy. JSLS. 2009 Jul-Sep;13(3):312-7. — View Citation
Milone M, Elmore U, Di Salvo E, Delrio P, Bucci L, Ferulano GP, Napolitano C, Angiolini MR, Bracale U, Clemente M, D'ambra M, Luglio G, Musella M, Pace U, Rosati R, Milone F. Intracorporeal versus extracorporeal anastomosis. Results from a multicentre com — View Citation
Roscio F, Bertoglio C, De Luca A, Frattini P, Scandroglio I. Totally laparoscopic versus laparoscopic assisted right colectomy for cancer. Int J Surg. 2012;10(6):290-5. doi: 10.1016/j.ijsu.2012.04.020. Epub 2012 May 4. — View Citation
Scatizzi M, Kröning KC, Borrelli A, Andan G, Lenzi E, Feroci F. Extracorporeal versus intracorporeal anastomosis after laparoscopic right colectomy for cancer: a case-control study. World J Surg. 2010 Dec;34(12):2902-8. doi: 10.1007/s00268-010-0743-6. — View Citation
van Oostendorp S, Elfrink A, Borstlap W, Schoonmade L, Sietses C, Meijerink J, Tuynman J. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Jan;31(1):64-77. doi: 10.1007/s0046 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of hospital stay | 1 month | ||
Secondary | Length of incisions | At the end of the operation | ||
Secondary | Intraoperative complications | intraoperatively | ||
Secondary | Number of lymph nodes harvested | evaluation of the number of lymph nodes in the specimen on pathology report | 3 weeks | |
Secondary | 30-day postoperative morbidity according to the Clavien-Dindo classification | 1 month | ||
Secondary | First gas and stool passage | 1 week | ||
Secondary | Evaluation of postoperative pain (VAS) | measurement of VAS scores | 1 week | |
Secondary | Duration of intravenous analgesic therapy | 1 week | ||
Secondary | Narcotics use rate | percentage of patients requiring narcotics after surgery | from day 1 to day 5 after surgery | |
Secondary | Reoperation rate | 1 week | ||
Secondary | Hospital readmission | rate and causes of hospital readmission | 90 days | |
Secondary | In-hospital costs | Cost analysis will be based on the following costs: surgical instruments (including re-usable trocars and disposable tools), operative room, routine postoperative surgical care, diagnosis and treatment of postoperative complications. Operative room costs included healthcare personnel, medications, and structure costs. To calculate the cost of each postoperative complication, the following items will be assessed: laboratory and microbiology analysis; medical, technical, and diagnostic services; surgical and therapeutic interventions; medications; prolonged hospital stay, and outpatient clinic follow-up. The mean length of hospital stay of uncomplicated patients will be the basis to calculate the prolonged hospital stay in each patient with complication. In patients who will develop multiple complications, resources used to treat each complication will be recorded separately. | 60 days | |
Secondary | Rate of incisional hernias | postoperatively at 3 and 6 months | ||
Secondary | Quality of life | the SF-12 questionnaire will assess quality of life | preoperatively, at 3 and 6 months after surgery |
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