Skip to content

Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.

Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03045107
Enrollment
140
Registered
2017-02-07
Start date
2017-02-01
Completion date
2020-07-30
Last updated
2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomosis, Colon Cancer

Keywords

right colon, laparoscopic right colectomy, intracorporeal anastomosis, extracorporeal anastomosis, hospital stay, quality of life, costs

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.

Interventions

PROCEDURELaparoscopic 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 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.

PROCEDURELaparoscopic 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. 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.

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

A big dressing covering all incisions will be applied at the end of each operation in both arms.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Length of hospital stay1 month

Secondary

MeasureTime frameDescription
Intraoperative complicationsintraoperatively
Number of lymph nodes harvested3 weeksevaluation of the number of lymph nodes in the specimen on pathology report
30-day postoperative morbidity according to the Clavien-Dindo classification1 month
First gas and stool passage1 week
Evaluation of postoperative pain (VAS)1 weekmeasurement of VAS scores
Duration of intravenous analgesic therapy1 week
Length of incisionsAt the end of the operation
Reoperation rate1 week
Hospital readmission90 daysrate and causes of hospital readmission
In-hospital costs60 daysCost 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 herniaspostoperatively at 3 and 6 months
Quality of lifepreoperatively, at 3 and 6 months after surgerythe SF-12 questionnaire will assess quality of life
Narcotics use ratefrom day 1 to day 5 after surgerypercentage of patients requiring narcotics after surgery

Countries

Italy

Contacts

Primary ContactMarco E Allaix, MD, PhD
mallaix@unito.it+390116335670

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026