Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Colon Cancer | Study protocol

Surgical site infection after intracorporeal anastomosis for left-sided colon cancer: study protocol for a non-inferiority multicenter randomized controlled trial (STARS)

Authors: Liang He, Meng Li, Jia-xin Zhang, Wei-hua Tong, Yan Chen, Quan Wang

Published in: Trials | Issue 1/2022

Login to get access

Abstract

Background

Surgical site infection (SSI), as one of the most common hospital-acquired infection, is usually associated with increased morbidity, mortality, and health care burden. SSI is a significant perioperative complication after colon cancer surgery, particularly for left-sided colon cancer. This paper describes the background and design of the “Surgical Site Infection after intracorporeal anastomosis for Left-sided Colon Cancer: study protocol for a non-inferiority multicenter Randomized Controlled Trial (STARS).” The STARS trial aims to compare the incidence of SSI after intracorporeal anastomosis and extracorporeal anastomosis after radical resection of colon cancer and to explore the risk factors of SSI.

Methods

A total of 354 left colon cancer patients from 8 hospitals in China will be enrolled in this multi-center randomized controlled study. The primary outcome of this study is the incidence of SSI 30 days after left-sided colon cancer surgery. Secondary outcome measures include operation time, blood loss, conversion rate, incidence of perioperative complications, completeness of resection, number of lymph nodes collected and postoperative recovery characteristics, 3-year disease-free survival, and 5-year overall survival. The first patient was enrolled in January 2021.

Discussion

To our knowledge, this is the first prospective multicenter study to investigate whether there is a difference in the SSI incidence after intracorporeal and extracorporeal anastomosis for left-sided colon cancer in China. The results may provide more evidence that supports performing total laparoscopic left-sided colon cancer surgery.

Trial registration

The trial has been registered on ClinicalTrials.gov website (ID: NCT04201717). Registered on September 22, 2020
Appendix
Available only for authorised users
Literature
1.
2.
Lee MS, Menter DG, Kopetz S. Right versus left colon cancer biology: integrating the consensus molecular subtypes. J Natl Compr Canc Netw. 2017;15(3):411–9.CrossRefPubMed
3.
Meguid RA, Slidell MB, Wolfgang CL, Chang DC, Ahuja N. Is there a difference in survival between right- versus left-sided colon cancers? Ann Surg Oncol. 2008;15(9):2388–94.CrossRefPubMedPubMedCentral
4.
Dienstmann R, Salazar R, Tabernero J. Personalizing colon cancer adjuvant therapy: selecting optimal treatments for individual patients. J Clin Oncol. 2015;33(16):1787–96.CrossRefPubMed
5.
Hawkins AT, Ford MM, Geiger TM, Hopkins MB, Kachnic LA, Muldoon RL, et al. Neoadjuvant radiation for clinical T4 colon cancer: a potential improvement to overall survival. Surgery. 2019;165(2):469–75.CrossRefPubMed
6.
Mohamed F. Colon cancer surgery: is it what you do, or the way you do it that matters? Lancet Gastroenterol Hepatol. 2017;2(4):237–8.CrossRefPubMed
7.
Liu ZH, Wang N, Wang FQ, Dong Q, Ding J. Oncological outcomes of laparoscopic versus open surgery in pT4 colon cancers: a systematic review and meta-analysis. Int J Surg. 2018;56:221–33.CrossRefPubMed
8.
Park JH, Park HC, Park SC, Sohn DK, Oh JH, Kang SB, et al. Laparoscopic approach for left-sided T4 colon cancer is a safe and feasible procedure, compared to open surgery. Surg Endosc. 2019;33(9):2843–9.CrossRefPubMed
9.
Kitano S, Inomata M, Mizusawa J, Katayama H, Watanabe M, Yamamoto S, et al. Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2017;2(4):261–8.CrossRefPubMed
10.
Yamaguchi S, Tashiro J, Araki R, Okuda J, Hanai T, Otsuka K, et al. Laparoscopic versus open resection for transverse and descending colon cancer: Short-term and long-term outcomes of a multicenter retrospective study of 1830 patients. Asian J Endosc Surg. 2017;10(3):268–75.CrossRefPubMed
11.
Zywot A, Lau CSM, Stephen Fletcher H, Paul S. Bundles prevent surgical site infections after colorectal surgery: meta-analysis and systematic review. J Gastrointest Surg. 2017;21(11):1915–30.CrossRefPubMed
12.
Olguín Joseau S, Bollati NP, Reimondez S, Signorini F, Rossini AM, Maldonado PS, et al. Risk factors for surgical site infection in colon surgery in our population. Rev Fac Cien Med Univ Nac Cordoba. 2018;75(4):229–33.CrossRefPubMed
13.
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999;27(2):97–132 quiz 133-134; discussion 196.CrossRefPubMed
14.
Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, et al. American College of Surgeons and Surgical Infection Society: surgical site infection guidelines, 2016 update. J Am Coll Surg. 2017;224(1):59–74.CrossRefPubMed
15.
Murray AC, Pasam R, Estrada D, Kiran RP. Risk of surgical site infection varies based on location of disease and segment of colorectal resection for cancer. Dis Colon Rectum. 2016;59(6):493–500.CrossRefPubMed
16.
Caroff DA, Chan C, Kleinman K, Calderwood MS, Wolf R, Wick EC, et al. Association of open approach vs laparoscopic approach with risk of surgical site infection after colon surgery. JAMA Netw Open. 2019;2(10):e1913570.CrossRefPubMedPubMedCentral
17.
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
18.
Hageman D, Caillet V, Kostohryz J, Madick S. Laparoscopic-assisted colon surgery. AORN J. 2008;88(3):403–12 quiz 413-406.CrossRefPubMed
19.
Kong AP, Tran CL, Stamos MJ. Laparoscopic-assisted colectomy: technique and discussion. Surg Technol Int. 2006;15:95–101.PubMed
20.
Su H, Jin W, Wang P, Bao M, Wang X, Zhao C, et al. Comparing short-time outcomes of three-dimensional and two-dimensional totally laparoscopic surgery for colon cancer using overlapped delta-shaped anastomosis. Onco Targets Ther. 2019;12:669–75.CrossRefPubMedPubMedCentral
21.
Swaid F, Sroka G, Madi H, Shteinberg D, Somri M, Matter I. Totally laparoscopic versus laparoscopic-assisted left colectomy for cancer: a retrospective review. Surg Endosc. 2016;30(6):2481–8.CrossRefPubMed
22.
23.
Sormani MP. The most frequently asked question to a statistician: the sample size. Mult Scler. 2017;23(5):644–6.CrossRefPubMed
24.
Badia JM, Casey AL, Petrosillo N, Hudson PM, Mitchell SA, Crosby C. Impact of surgical site infection on healthcare costs and patient outcomes: a systematic review in six European countries. J Hosp Infect. 2017;96(1):1–15.CrossRefPubMed
Metadata
Title
Surgical site infection after intracorporeal anastomosis for left-sided colon cancer: study protocol for a non-inferiority multicenter randomized controlled trial (STARS)
Authors
Liang He
Meng Li
Jia-xin Zhang
Wei-hua Tong
Yan Chen
Quan Wang
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06914-5

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue

Study protocol

Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial

Study protocol

Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium-risk hypertensive patients: study protocol for a randomized double-blind controlled trial

Study protocol

Implant migration and functional outcome of Reverse Shoulder Lateralized Glenosphere Line Extension System: a study protocol for a randomized controlled trial

Study protocol

Prophylactic abdominal drainage or no drainage after distal pancreatectomy (PANDORINA): a binational multicenter randomized controlled trial

Study protocol

Effect of vaginal antiseptic prior to caesarean section on the rate of post-caesarean complications: a blinded randomised controlled trial

Research

Recruitment to a large scale randomised controlled clinical trial in primary care: the Helicobacter Eradication Aspirin Trial (HEAT)