Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.
Intracorporeal or Extracorporeal 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.
While there are no differences in oncologic principles (no touch technique, proximal vessel
 ligation, lymphadenectomy) between laparoscopic right colectomy with IIA and EIA, potential
 advantages of IIA are: (1) no need for extensive mobilization of the transverse colon to
 reach the abdominal wall; (2) performing the anastomosis away from the abdominal wall may
 lead to reduced rates of superficial site infection; (3) a shorter incision for the specimen
 extraction may be associated with clinical benefits such as less pain and lower rates of
 superficial site infections; (4) laparoscopic visualization during the creation of the IIA
 may reduce unrecognized twisting of the terminal ileum mesentery, and (5) the ability to
 remove the specimen through any type of incision, with subsequent reduced risks of incisional
 hernias in case of Pfannenstiel incision when compared to midline or off-midline incisions.

 Some retrospective and heterogeneous studies comparing perioperative outcomes after
 laparoscopic right colectomy with EIA and IIA have been published in the last decade,
 reporting controversial results. Furthermore, the results of recent metanalyses are
 challenged by the heterogeneity and the poor quality of the published studies. Lastly, no
 comprehensive economic evaluation of the two procedures have been performed yet.

 Consecutive patients with right colon tumors are included in a randomized controlled trial.
 This is a single Institution prospective randomized controlled trial comparing the outcomes
 in patients undergoing laparoscopic right colectomy with IIA or EIA for right colon neoplasm.
 Eligible patients will be randomly assigned in a 1:1 ratio to undergo either laparoscopic IA
 or EA according to a list of randomization numbers with treatment assignments. This list will
 be computer generated. An Internet application will allow central randomization.

 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 include 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.
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.