Surgical Site InfectionNCT04350203
Surgical-Site Infection After Laparoscopic Right Colectomy
An observational study of Surgical Site Infection, run by Hospital Plató at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Laparoscopic right colectomy with intracorporeal anastomosis (IA) and Laparoscopic right colectomy with extracorporeal anastomosis (EA)
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2011to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients over 18 years candidates for scheduled surgery requiring laparoscopic right colon resection (ascendant or transverse colon)
Who may be able to join
- patients over 18 years candidates for scheduled surgery with curative intention to resect a benign or malignant neoplasm of the right colon
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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].
- Conditions
- Surgical Site Infection
- Being tested
- Laparoscopic right colectomy with intracorporeal anastomosis (IA), Laparoscopic right colectomy with extracorporeal anastomosis (EA)
- Keywords
- Right Colectomy, Laparoscopy, Intracorporeal Anastomosis, Extracorporeal Anastomosis, Colorectal Cancer
- Medical subject headings
- Surgical Wound Infection, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic right colectomy with intracorporeal anastomosis (IA)Procedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal Anatomosis (IA) | Laparoscopic Right colectomy with intracorporeal (IA) side-to-side isoperistaltic anastomosis Receives: Procedure: Laparoscopic right colectomy with intracorporeal anastomosis (IA) | |
| Extracorporeal Anastomosis (EA) | Patients submitted to a Laparoscopic Right Colectomy with extracorporeal anastomosis (EA) Receives: Procedure: Laparoscopic right colectomy with extracorporeal anastomosis (EA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak rate
percentage of clinical anastomotic leak leading to an intervention
Measured: 30 days
Intraabdominal Abscess rate
percentage of abdominal abscess (clinical or radiological) leading to an intervention (surgical or percutaneous)
Measured: 30 days
Wound Infection
percentage of wound infection (deep or superficial)
Measured: 30 days
Secondary outcomes (4)
Length of Hospital Stay
days that patients required hospitalization
Measured: 30 days
postoperative complications 1
global morbidity evaluated according the Dindo-Clavien Classification
Measured: 30 days
postoperative complications 2
postoperative haemorrhage needing intervention (surgical or endoscopic)
Measured: 30 days
Operating time of the procedure
Total duration of the surgical procedure (in minutes)
Measured: During the perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jan 2011
- Primary completion1 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Plató
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Hoyuela, MD, PhD, Principal investigator, Chief, Dept. of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350203
- Sponsor's protocol ID
- HPlato
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1759770van 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.
PubMed 27287905Clavien 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.
PubMed 19638912Hoyuela 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.
PubMed 33590349
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical-Site Infection After Laparoscopic Right Colectomy: A Cohort Study Comparing Intracorporeal Anastomosis in Front of Extracorporeal Anastomosis
- ClinicalTrials.gov ID
- NCT04350203
- Acronym / sponsor ID
- HPlato
- Conditions
- Surgical Site Infection
- Keywords
- Right Colectomy, Laparoscopy, Intracorporeal Anastomosis, Extracorporeal Anastomosis, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hospital PlatóUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal Anatomosis (IA) | – | Procedure: Laparoscopic right colectomy with intracorporeal anastomosis (IA)Laparoscopic Right colectomy with intracorporeal (IA) side-to-side isoperistaltic anastomosis |
| Extracorporeal Anastomosis (EA) | – | Procedure: Laparoscopic right colectomy with extracorporeal anastomosis (EA)Patients submitted to a Laparoscopic Right Colectomy with extracorporeal anastomosis (EA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients over 18 years candidates for scheduled surgery requiring laparoscopic right colon resection (ascendant or transverse colon)
Key inclusion criteria (1 listed)
- patients over 18 years candidates for scheduled surgery with curative intention to resect a benign or malignant neoplasm of the right colon
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Intracorporeal Anatomosis (IA) |
| 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. | Procedure or surgery | Extracorporeal Anastomosis (EA) |
Primary outcome
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)
4 secondary outcomes
Length of Hospital Stay
Time frame: 30 days
postoperative complications 1
Time frame: 30 days
postoperative complications 2
Time frame: 30 days
Operating time of the procedure
Time frame: During the perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Background: PubMed 1759770Peel 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.
- Background: PubMed 27287905van 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.
- Background: PubMed 19638912Clavien 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.
- Derived from this study: PubMed 33590349Hoyuela 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.
- American Society of Anesthesiologists. ASA Physical Status Classification SystemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Hoyuela, MD, PhD principal investigator
Chief, Dept. of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Hospital Plató at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leak rate (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04350203, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.