Surgical-Site Infection After Laparoscopic Right Colectomy

Completed

• Conditions: Surgical Site Infection
• Interventions: Procedure: Laparoscopic right colectomy with intracorporeal anastomosis (IA); Procedure: Laparoscopic right colectomy with extracorporeal anastomosis (EA)

• Registration Number: NCT04350203
• Lead Sponsor: Hospital Plató

Brief Summary

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.

Detailed 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 \[4\].

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-28
• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Study First Posted: 2020-04-16
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Anastomotic leak rate	30 days	percentage of clinical anastomotic leak leading to an intervention
Wound Infection	30 days	percentage of wound infection (deep or superficial)
Intraabdominal Abscess rate	30 days	percentage of abdominal abscess (clinical or radiological) leading to an intervention (surgical or percutaneous)

Secondary Outcome Measures

Name	Time	Method
postoperative complications 2	30 days	postoperative haemorrhage needing intervention (surgical or endoscopic)
postoperative complications 1	30 days	global morbidity evaluated according the Dindo-Clavien Classification
Length of Hospital Stay	30 days	days that patients required hospitalization
Operating time of the procedure	During the perioperative period	Total duration of the surgical procedure (in minutes)

Trial Locations

Locations (1)

Hospital Plató; 🇪🇸 Barcelona, Spain