Skip to main content
OpenTrials
Completed

NCT Number: NCT04350203

Surgical-Site Infection After Laparoscopic Right Colectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic right colectomy with intracorporeal anastomosis (IA)

Procedure

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)

Procedure

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.

Primary outcomes

  1. Anastomotic leak rate

    Time frame: 30 days

    percentage of clinical anastomotic leak leading to an intervention

  2. Intraabdominal Abscess rate

    Time frame: 30 days

    percentage of abdominal abscess (clinical or radiological) leading to an intervention (surgical or percutaneous)

  3. Wound Infection

    Time frame: 30 days

    percentage of wound infection (deep or superficial)

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: 30 days

    days that patients required hospitalization

  2. postoperative complications 1

    Time frame: 30 days

    global morbidity evaluated according the Dindo-Clavien Classification

  3. postoperative complications 2

    Time frame: 30 days

    postoperative haemorrhage needing intervention (surgical or endoscopic)

  4. Operating time of the procedure

    Time frame: During the perioperative period

    Total duration of the surgical procedure (in minutes)

Sponsors and collaborators

Lead sponsor

Hospital Plató

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2020
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.