Surgical-Site Infection After Laparoscopic Right Colectomy
1 other identifier
observational
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedFirst Submitted
Initial submission to the registry
April 14, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedApril 16, 2020
April 1, 2020
9.1 years
April 14, 2020
April 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Anastomotic leak rate
percentage of clinical anastomotic leak leading to an intervention
30 days
Intraabdominal Abscess rate
percentage of abdominal abscess (clinical or radiological) leading to an intervention (surgical or percutaneous)
30 days
Wound Infection
percentage of wound infection (deep or superficial)
30 days
Secondary Outcomes (4)
Length of Hospital Stay
30 days
postoperative complications 1
30 days
postoperative complications 2
30 days
Operating time of the procedure
During the perioperative period
Study Arms (2)
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)
Interventions
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).
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.
Eligibility Criteria
patients over 18 years candidates for scheduled surgery requiring laparoscopic right colon resection (ascendant or transverse colon)
You may qualify if:
- patients over 18 years candidates for scheduled surgery with curative intention to resect a benign or malignant neoplasm of the right colon
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Platólead
Study Sites (1)
Hospital Plató
Barcelona, 08006, Spain
Related Publications (4)
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.
PMID: 1759770BACKGROUNDvan 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.
PMID: 27287905BACKGROUNDClavien 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.
PMID: 19638912BACKGROUNDHoyuela 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.
PMID: 33590349DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Hoyuela, MD, PhD
Chief, Dept. of Surgery
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2020
First Posted
April 16, 2020
Study Start
January 1, 2011
Primary Completion
February 1, 2020
Study Completion
February 28, 2020
Last Updated
April 16, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share