Elective Laparoscopic Surgery, Neoplastic or Benign Disease of Right Colon
Conditions
Keywords
Laparoscopic surgery, Right colectomy, Mechanical anastomosis, Post-operative ileum
Brief summary
Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis.
Interventions
PROCEDURELaparoscopic right colectomy
Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L
Sponsors
Scientific Institute San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or more * Benign o neoplastic disease of right colon * Elective laparoscopic surgery
Exclusion criteria
* Emergency surgery * Adhesion or infiltration of near organs * Severe heart disease ( New York Heart Association class \> 3 ) * Severe respiratory disease ( arterial PO2 \< 70 torr ) * Severe Liver disease (Child-Pugh class C) * Ongoing infections * Number of plasmatic neutrophil \< a 2.0 x 10 9/L * Other contraindications to laparoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative canalisation time and length of stay | Post-operative stay (about 7 days) | Comparison of post-operative bowel movement time (fist flastus and first dejection) and overall length of stay between the two study groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of post-operative ileum and complications. Valuation of global costs | 12 months | Comparison of post-operative short and long-term complications (in particular post-operative ileum) between the two study groups. Valuation of global costs differences. |
Countries
Italy
Contacts
Primary ContactAndrea Vignali, MD
Outcome results
None listed