Clinical trial NCT03045107: Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.
Official title: Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Anastomosis
Keywords: right colon
laparoscopic right colectomy
intracorporeal anastomosis
extracorporeal anastomosis
hospital stay
quality of life
costs
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of hospital stay
timeFrame: 1 month
Secondary outcomes:
measure: Length of incisions
timeFrame: At the end of the operation
measure: Intraoperative complications
timeFrame: intraoperatively
measure: Number of lymph nodes harvested
timeFrame: 3 weeks
measure: 30-day postoperative morbidity according to the Clavien-Dindo classification
timeFrame: 1 month
measure: First gas and stool passage
timeFrame: 1 week
measure: Evaluation of postoperative pain (VAS)
timeFrame: 1 week
measure: Duration of intravenous analgesic therapy
timeFrame: 1 week
measure: Narcotics use rate
timeFrame: from day 1 to day 5 after surgery
measure: Reoperation rate
timeFrame: 1 week
measure: Hospital readmission
timeFrame: 90 days
measure: In-hospital costs
timeFrame: 60 days
measure: Rate of incisional hernias
timeFrame: postoperatively at 3 and 6 months
measure: Quality of life
timeFrame: preoperatively, at 3 and 6 months after surgery
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Department of Surgical Sciences, University of Torino, AOU Città della Salute e della Scienza
Study officials:
affiliation: University of Turin, Italy
name: Mario Morino, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Seno E, Allaix ME, Ammirati CA, Bonino MA, Arezzo A, Mistrangelo M, Morino M. Intracorporeal or extracorporeal ileocolic anastomosis after laparoscopic right colectomy: cost analysis of the Torino trial. Surg Endosc. 2023 Jan;37(1):479-485. doi: 10.1007/s00464-022-09546-7. Epub 2022 Aug 23.
citation: Allaix ME, Degiuli M, Bonino MA, Arezzo A, Mistrangelo M, Passera R, Morino M. Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy: A Double-blinded Randomized Controlled Trial. Ann Surg. 2019 Nov;270(5):762-767. doi: 10.1097/SLA.0000000000003519.