Surgical-Site Infection After Laparoscopic Right Colectomy

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: February 1, 2020

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].

Interventions

  • Procedure: Laparoscopic right colectomy with intracorporeal anastomosis (IA)
    • 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).
  • Procedure: 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Plató
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Carlos Hoyuela, MD, PhD, Principal Investigator, Chief, Dept. of Surgery

References

Peel AL, Taylor EW. Proposed definitions for the audit of postoperative infection: a discussion paper. Surgical Infection Study Group. Ann R Coll Surg Engl. 1991 Nov;73(6):385-8.

van Oostendorp S, Elfrink A, Borstlap W, Schoonmade L, Sietses C, Meijerink J, Tuynman J. Intracorporeal versus extracorporeal anastomosis in right hemicolectomy: a systematic review and meta-analysis. Surg Endosc. 2017 Jan;31(1):64-77. doi: 10.1007/s00464-016-4982-y. Epub 2016 Jun 10. Review.

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

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