Clinical trial NCT04350203: Surgical-Site Infection After Laparoscopic Right Colectomy
Official title: Surgical-Site Infection After Laparoscopic Right Colectomy: A Cohort Study Comparing Intracorporeal Anastomosis in Front of Extracorporeal Anastomosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Keywords: Right Colectomy
Laparoscopy
Intracorporeal Anastomosis
Extracorporeal Anastomosis
Colorectal Cancer
Lead sponsor: Hospital Plató
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients over 18 years candidates for scheduled surgery requiring laparoscopic right colon resection (ascendant or transverse colon)

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 \[4\].

Eligibility criteria: 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.

Primary outcomes:
measure: Anastomotic leak rate
timeFrame: 30 days
measure: Intraabdominal Abscess rate
timeFrame: 30 days
measure: Wound Infection
timeFrame: 30 days
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: 30 days
measure: postoperative complications 1
timeFrame: 30 days
measure: postoperative complications 2
timeFrame: 30 days
measure: Operating time of the procedure
timeFrame: During the perioperative period
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Plató
Study officials:
affiliation: Chief, Dept. of Surgery
name: Carlos Hoyuela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes 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.
citation: Hoyuela C, Guillaumes S, Ardid J, Hidalgo NJ, Bachero I, Trias M, Martrat A. The impact of intracorporeal anastomosis in right laparoscopic colectomy in the surgical site infections and the hospital stay: a cohort study. Updates Surg. 2021 Dec;73(6):2125-2135. doi: 10.1007/s13304-021-00998-5. Epub 2021 Feb 15.