Surgical-Site Infection After Laparoscopic Right Colectomy

April 14, 2020 updated by: Hospital Plató

Surgical-Site Infection After Laparoscopic Right Colectomy: A Cohort Study Comparing Intracorporeal Anastomosis in Front of Extracorporeal Anastomosis

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08006
        • Hospital Plató

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients over 18 years candidates for scheduled surgery requiring laparoscopic right colon resection (ascendant or transverse colon)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intracorporeal Anatomosis (IA)
Laparoscopic Right colectomy with intracorporeal (IA) side-to-side isoperistaltic anastomosis
First, the right colon dissection was completed by laparoscopy. An isoperistaltic side-to-side ileocolonic mechanical anastomosis was then performed by using a linear cutting stapler. The enterotomy used to enter the stapler was closed with a running suture (3-0 absorbable monofilament or a 3-0 barbed suture). Finally, the specimen was extracted through a Pfannenstiel mini-laparotomy (4-5 cm).
Extracorporeal Anastomosis (EA)
Patients submitted to a Laparoscopic Right Colectomy with extracorporeal anastomosis (EA)
First, the right colon was widely mobilized. A small laparotomy was performed in the mid/upper abdomen to exteriorize the colon and to perform a side-to-side mechanical anastomosis, using a linear cutting stapler (GIA). The bowel opening was closed either with a manual suture or by a second firing of the GIA.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Carlos Hoyuela, MD, PhD, Chief, Dept. of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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