PMID- 33176211
OWN - NLM
STAT- MEDLINE
DCOM- 20210405
LR  - 20210405
IS  - 1743-9159 (Electronic)
IS  - 1743-9159 (Linking)
VI  - 84
DP  - 2020 Dec
TI  - Assessment of a circular powered stapler for creation of anastomosis in 
      left-sided colorectal surgery: A prospective cohort study.
PG  - 140-146
LID - S1743-9191(20)30772-X [pii]
LID - 10.1016/j.ijsu.2020.11.001 [doi]
AB  - BACKGROUND: Circular staplers perform a critical function for creation of 
      anastomoses in colorectal surgeries. Powered stapling systems allow for reduced 
      force required by surgeons to fire the device and may provide advantages for 
      creating a secure anastomosis. The objective of this study was to evaluate the 
      clinical performance of a novel circular powered stapler in a post-market 
      setting, during left-sided colectomy procedures. MATERIALS AND METHODS: 
      Consecutive subjects underwent left-sided colorectal resections that included 
      anastomosis performed with the ECHELON CIRCULAR Powered Stapler (ECP). The 
      primary endpoint was the frequency in which a stapler performance issue was 
      observed. Secondary endpoints included evaluation of ease of use of the device 
      via a surgeon satisfaction questionnaire, and monitoring/recording of 
      procedure-related adverse events (AEs). RESULTS: A total of 168 anastomoses were 
      performed with the ECP. Surgical approaches included robotic-assisted (n = 74, 
      44.0%), laparoscopic (n = 71, 42.3%), open (n = 20, 11.9%), and hand-assisted 
      minimally invasive (n = 3, 1.8%) procedures. There were 22 occurrences of device 
      performance issues in 20 (11.9%) subjects during surgery. No positive 
      intraoperative leak tests were observed, and only 1 issue was related to a 
      procedure-related AE or surgical complication, which was an instance of 
      incomplete surgical donut necessitating re-anastomosis. Postoperative anastomotic 
      leaks were experienced in 4 (2.4%) subjects. Clavien-Dindo classification of all 
      AEs indicated that 92.0% were Grades I or II. Participating surgeons rated the 
      ECP as easier to use compared to previously used manual circular staplers in 
      85.7% of procedures. CONCLUSION: The circular powered stapler exhibited few 
      clinically relevant performance issues, an overall favorable safety profile, and 
      ease of use for creation of left-sided colon anastomoses.
CI  - Copyright (c) 2020 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights 
      reserved.
FAU - Herzig, Daniel O
AU  - Herzig DO
AD  - Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 
      97239, USA.
FAU - Ogilvie, James W
AU  - Ogilvie JW
AD  - Spectrum Health, 4100 Lake Dr SE STE 205, Grand Rapids, MI, USA.
FAU - Chudzinski, Allen
AU  - Chudzinski A
AD  - AdventHealth Tampa, 3000 Medical Park Dr #500, Tampa, FL, 33611, USA.
FAU - Ferrara, Andrea
AU  - Ferrara A
AD  - Colon and Rectal Clinic of Orlando, Orlando, FL, USA.
FAU - Ashraf, Shazad Q
AU  - Ashraf SQ
AD  - University Hospitals Birmingham NHS, Queen Elizabeth Hospital, Mindelsohn Way, 
      Edgbaston, Birmingham, B15 2GW, UK.
FAU - Jimenez-Rodriguez, Rosa M
AU  - Jimenez-Rodriguez RM
AD  - Hospital Universitario Virgen Del Rocio, Unidad de Coloproctologia, Sevilla, 
      41013, Spain.
FAU - Van der Speeten, Kurt
AU  - Van der Speeten K
AD  - Ziekenhuis Oost-Limburg, Schiepse Bos 6, 3600, Genk, Belgium.
FAU - Kinross, James
AU  - Kinross J
AD  - St. Mary's Hospital, Imperial College London, Praed St, Paddington, London, W2 
      1NY, UK.
FAU - Schimmelpenning, Hendrik
AU  - Schimmelpenning H
AD  - Schon Klinik Neustadt, Am Kiebitzberg 10 D, 23730, Neustadt in Holstein, Germany.
FAU - Sagar, Peter M
AU  - Sagar PM
AD  - St James's University Hospital, Beckett St, Leeds, LS9 7TF, UK.
FAU - Cannon, Jamie A
AU  - Cannon JA
AD  - University of Alabama Birmingham School of Medicine, 2000 6th Ave S 1st Floor, 
      Birmingham, AL, 35233, USA.
FAU - Schwiers, Michael L
AU  - Schwiers ML
AD  - Ethicon Endo-Surgery, Inc, 4545 Creek Rd, Blue Ash, OH, 45242, USA.
FAU - Singleton, David W
AU  - Singleton DW
AD  - Ethicon Endo-Surgery, Inc, 4545 Creek Rd, Blue Ash, OH, 45242, USA. Electronic 
      address: dsingl12@its.jnj.com.
FAU - Waggoner, Jason R
AU  - Waggoner JR
AD  - Ethicon Endo-Surgery, Inc, 4545 Creek Rd, Blue Ash, OH, 45242, USA.
FAU - Fryrear, Raymond 2nd
AU  - Fryrear R 2nd
AD  - Ethicon Endo-Surgery, Inc, 4545 Creek Rd, Blue Ash, OH, 45242, USA.
FAU - Sylla, Patricia
AU  - Sylla P
AD  - Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, 5 E 98th St 14th 
      Fl, Ste D, New York, NY, 10029, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20201108
PL  - United States
TA  - Int J Surg
JT  - International journal of surgery (London, England)
JID - 101228232
SB  - IM
CIN - Int J Surg. 2021 Jan;85:55-56. PMID: 33359387
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anastomosis, Surgical/adverse effects/*methods
MH  - Colectomy/adverse effects/instrumentation/*methods
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - *Surgical Staplers
OTO - NOTNLM
OT  - Anastomosis
OT  - Anastomotic leak
OT  - Circular stapler
OT  - Colectomy
OT  - Colorectal
OT  - Powered stapler
EDAT- 2020/11/12 06:00
MHDA- 2021/04/07 06:00
CRDT- 2020/11/11 20:08
PHST- 2020/07/27 00:00 [received]
PHST- 2020/10/31 00:00 [revised]
PHST- 2020/11/03 00:00 [accepted]
PHST- 2020/11/12 06:00 [pubmed]
PHST- 2021/04/07 06:00 [medline]
PHST- 2020/11/11 20:08 [entrez]
AID - S1743-9191(20)30772-X [pii]
AID - 10.1016/j.ijsu.2020.11.001 [doi]
PST - ppublish
SO  - Int J Surg. 2020 Dec;84:140-146. doi: 10.1016/j.ijsu.2020.11.001. Epub 2020 Nov 
      8.