Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.
- Conditions
- Colon CancerAnastomosis
- Interventions
- Procedure: Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA)Procedure: Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA)
- Registration Number
- NCT03045107
- Lead Sponsor
- University of Turin, Italy
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intracorporeal ileocolic anastomosis (IIA) Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA) 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. Extracorporeal ileocolic anastomosis Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA) 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.
- Primary Outcome Measures
Name Time Method Length of hospital stay 1 month
- Secondary Outcome Measures
Name Time Method Hospital readmission 90 days rate and causes of hospital readmission
Length of incisions At the end of the operation Intraoperative complications intraoperatively Number of lymph nodes harvested 3 weeks evaluation of the number of lymph nodes in the specimen on pathology report
30-day postoperative morbidity according to the Clavien-Dindo classification 1 month First gas and stool passage 1 week Evaluation of postoperative pain (VAS) 1 week measurement of VAS scores
Duration of intravenous analgesic therapy 1 week Narcotics use rate from day 1 to day 5 after surgery percentage of patients requiring narcotics after surgery
Reoperation rate 1 week In-hospital costs 60 days 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.
Rate of incisional hernias postoperatively at 3 and 6 months Quality of life preoperatively, at 3 and 6 months after surgery the SF-12 questionnaire will assess quality of life
Trial Locations
- Locations (1)
Department of Surgical Sciences, University of Torino, AOU Città della Salute e della Scienza
🇮🇹Torino, Italy