Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy.

Conditions
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Colon Cancer, Anastomosis

Intervention / Treatment
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* Procedure: Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA)
* Procedure: Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracorporeal ileocolic anastomosis (IIA)<br>After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected and a side-to-side anastomosis is fashioned with a laparoscopic stapler. | Procedure: Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA)<br>* After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The antimesenteric side of the stapled ends of the transverse colon and terminal ileum are approximated by a stay suture tied intracorporeally and then held by the assistant. An antimesenteric enterotomy and an antimesenteric colotomy are made about 10 cm distal to the stapled ends of the transverse colon and terminal ileum, respectively. A side-to-side anastomosis is fashioned with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The enterotomies are then closed by two layers of reabsorbable sutures tied intracorporeally. The specimen is delivered through a small Pfannenstiel or a median incision. A big dressing covering all incisions will be applied, similar to that used for the EIA group.<br>|
| Active Comparator: Extracorporeal ileocolic anastomosis<br>After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. Then, a primary ileocolic side-to-side handsewn or mechanical anastomosis is fashioned extracorporeally. | Procedure: Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA)<br>* After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. A primary ileocolic side-to-side handsewn or mechanical (with GIA stapler - Covidien Medtronic) anastomosis is fashioned and the bowel returned to the abdominal cavity. After reinduction of pneumoperitoneum, the lack of twists of the ileocolic anastomosis is checked. A big dressing covering all incisions will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of incisions |  | At the end of the operation | 
| Intraoperative complications |  | intraoperatively | 
| Number of lymph nodes harvested | evaluation of the number of lymph nodes in the specimen on pathology report | 3 weeks | 
| 30-day postoperative morbidity according to the Clavien-Dindo classification |  | 1 month | 
| First gas and stool passage |  | 1 week | 
| Evaluation of postoperative pain (VAS) | measurement of VAS scores | 1 week | 
| Duration of intravenous analgesic therapy |  | 1 week | 
| Narcotics use rate | percentage of patients requiring narcotics after surgery | from day 1 to day 5 after surgery | 
| Reoperation rate |  | 1 week | 
| Hospital readmission | rate and causes of hospital readmission | 90 days | 
| 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 | 
| Rate of incisional hernias |  | postoperatively at 3 and 6 months | 
| Quality of life | the SF-12 questionnaire will assess quality of life | preoperatively, at 3 and 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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right colon, laparoscopic right colectomy, intracorporeal anastomosis, extracorporeal anastomosis, hospital stay, quality of life, costs