Surgical-Site Infection After Laparoscopic Right Colectomy

H

Hospital Plató

Status

Completed

Conditions

Surgical Site Infection

Treatments

Procedure: Laparoscopic right colectomy with intracorporeal anastomosis (IA)
Procedure: Laparoscopic right colectomy with extracorporeal anastomosis (EA)

Study type

Observational

Funder types

Other

Identifiers

NCT04350203
HPlato

Details and patient eligibility

About

Laparoscopic right colectomy with intracorporeal anastomosis seems to be associated with several short-term benefits. It could reduce the postoperative infection rate and shorten the hospital stay. This study aimed to evaluate the postoperative surgical site infection (SSI) rate after laparoscopic right hemicolectomy with intracorporeal anastomosis, compared to extracorporeal anastomoses.

Full description

This is a comparative cohort study of two anastomosis techniques for laparoscopic right hemicolectomy. Between 2011 and 2019, all unselected consecutive patients who underwent a laparoscopic resection of the right colon were considered to be included in the study. The inclusion and exclusion criteria are detailed in the section below. Data were extracted from a prospectively maintained colorectal surgery database of a university-affiliated hospital in Barcelona. All included patients signed a standard consent form after being informed about the characteristics of the procedure. Institutional board approval was obtained before the review of the patients' data. Patients were divided into two groups, depending on the anastomotic technique performed: intracorporeal (IA) or extracorporeal. The primary endpoint of the study was to determine the surgical-site infection (SSI) rate and its potential impact on the length of hospital stay. Anastomotic leak was defined as a "leak of luminal contents from a surgical join between two hollow viscera" according to the Surgical Infection Study Group [1]. The evaluation of SSI, intraabdominal abscess and wound infection (both superficial and deep), was based on the Centers for Disease and Prevention definitions [2]. Secondary endpoints included other short-term postoperative complications (30 days), besides the SSI: hemorrhage (intraabdominal and anastomotic), ileus (intolerance to oral feeding beyond the fourth postoperative day or the need for insertion of a nasogastric tube), evisceration, medical complications, reoperations, and mortality. The severity of the complications was reported using the Clavien-Dindo classification [3]. The following variables were also collected: operating time (from the start of the incision to skin closure), concomitant surgery performed, assistance incision site (for anastomosis or specimen retrieval), conversion rate to open surgery (need for a laparotomy wider than 10 cm.), and oncological parameters as the size of the tumor, the depth of wall invasion (T) and the lymph node harvest. Patient demographics characteristics analyzed were age, sex, body mass index (BMI), and associated comorbidities. The anesthetic risk was measured according to the American Society of Anesthesiologists (ASA) classification system [4].

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients over 18 years candidates for scheduled surgery with curative intention to resect a benign or malignant neoplasm of the right colon

Exclusion criteria

  • stage IV disease (distant metastatic or intraabdominal disseminated disease that contraindicates surgery with curative intention)
  • emergency operation for complicated disease
  • medical contraindication for general anesthesia
  • pregnancy
  • chronic renal insufficiency requiring dialysis
  • or patient refusal and/or absence of informed consent.

Trial design

108 participants in 2 patient groups

Intracorporeal Anatomosis (IA)
Description:
Laparoscopic Right colectomy with intracorporeal (IA) side-to-side isoperistaltic anastomosis
Treatment:
Procedure: Laparoscopic right colectomy with intracorporeal anastomosis (IA)
Extracorporeal Anastomosis (EA)
Description:
Patients submitted to a Laparoscopic Right Colectomy with extracorporeal anastomosis (EA)
Treatment:
Procedure: Laparoscopic right colectomy with extracorporeal anastomosis (EA)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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