Surgical-Site Infection After Laparoscopic Right Colectomy

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350203
• Other study ID #: HPlato
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2020
• Source: Hospital Plató
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 28, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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).
• 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.

Locations

Country	Name	City	State
Spain	Hospital Plató	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Plató

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leak rate	percentage of clinical anastomotic leak leading to an intervention	30 days
Primary	Intraabdominal Abscess rate	percentage of abdominal abscess (clinical or radiological) leading to an intervention (surgical or percutaneous)	30 days
Primary	Wound Infection	percentage of wound infection (deep or superficial)	30 days
Secondary	Length of Hospital Stay	days that patients required hospitalization	30 days
Secondary	postoperative complications 1	global morbidity evaluated according the Dindo-Clavien Classification	30 days
Secondary	postoperative complications 2	postoperative haemorrhage needing intervention (surgical or endoscopic)	30 days
Secondary	Operating time of the procedure	Total duration of the surgical procedure (in minutes)	During the perioperative period

External Links

•   American Society of Anesthesiologists. ASA Physical Status Classification System
•   Centers for Disease Control and Prevention. National Healthcare Safety Network (NHSN) Procedure-Associated (PA) Module: Surgical Site Infection (SSI) Event