PMID- 34463946
OWN - NLM
STAT- MEDLINE
DCOM- 20211123
LR  - 20220218
IS  - 2038-3312 (Electronic)
IS  - 2038-131X (Print)
IS  - 2038-131X (Linking)
VI  - 73
IP  - 6
DP  - 2021 Dec
TI  - Comparison of a new gasless method and the conventional CO(2) pneumoperitoneum 
      method in laparoendoscopic single-site cholecystectomy: a prospective randomized 
      clinical trial.
PG  - 2231-2238
LID - 10.1007/s13304-021-01154-9 [doi]
AB  - To avoid CO(2) pneumoperitoneum-associated cardiopulmonary side-effects during 
      conventional laparoscopic surgeries, we have developed a gasless laparoscopic 
      operation field formation (LOFF) device for laparoendoscopic single-site surgery. 
      The aim of this study is to analyze the safety and efficacy of the LOFF device 
      for laparoendoscopic single-site cholecystectomy and to verify its advantage of 
      avoiding CO(2) pneumoperitoneum-associated complications. In this prospective, 
      randomized, observer-blinded clinical trial, eligible participants were 
      randomized in a 1:1 ratio to undergo either conventional CO(2) pneumoperitoneum 
      assisted laparoendoscopic single-site cholecystectomy (LESS) or the new gasless 
      LOFF device assisted laparoendoscopic single-site cholecystectomy (LOFF-LESS). 
      Outcomes including intra-operative respiratory and hemodynamic parameters, 
      operation time, conversion rate, complication rate, et al were compared between 
      the two groups. A total of 100 patients were randomized to the LESS group 
      [n = 50; mean (SD) age, 49.5 (13.9) years; 24 (48.0%) women] and the LOFF-LESS 
      group [n = 50, mean (SD) age, 47.4 (13.3) years; 27 (54.0%) women]. Compared with 
      the LOFF-LESS group, the LESS group witnessed significant fluctuations in 
      intra-operative respiratory and hemodynamic parameters. The tracheal extubation 
      time of the LESS group was significantly longer (P = 0.001). The gasless LOFF 
      device is safe and feasible for simple laparoscopic cholecystectomy and has a 
      predominance of avoiding CO(2) pneumoperitoneum-associated cardiopulmonary 
      side-effects. Trial registration number: ChiCTR2000033702.
CI  - (c) 2021. The Author(s).
FAU - Jiang, Min
AU  - Jiang M
AD  - Center of Gallstone Disease, Shanghai East Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Zhao, Gang
AU  - Zhao G
AD  - Center of Gallstone Disease, Shanghai East Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Huang, Anhua
AU  - Huang A
AD  - Center of Gallstone Disease, Shanghai East Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Zhang, Kai
AU  - Zhang K
AD  - Center of Gallstone Disease, Shanghai East Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Wang, Bo
AU  - Wang B
AD  - Center of Gallstone Disease, Shanghai East Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Jiang, Zhaoyan
AU  - Jiang Z
AD  - Center of Gallstone Disease, Shanghai East Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Ding, Kan
AU  - Ding K
AD  - Center of Gallstone Disease, Shanghai East Hospital, Tongji University School of 
      Medicine, Shanghai, China.
FAU - Hu, Hai
AU  - Hu H
AUID- ORCID: 0000-0003-3964-8827
AD  - Center of Gallstone Disease, Shanghai East Hospital, Tongji University School of 
      Medicine, Shanghai, China. tongji_east@sina.com.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210831
PL  - Italy
TA  - Updates Surg
JT  - Updates in surgery
JID - 101539818
RN  - 142M471B3J (Carbon Dioxide)
SB  - IM
MH  - Carbon Dioxide
MH  - Cholecystectomy
MH  - *Cholecystectomy, Laparoscopic/adverse effects
MH  - Female
MH  - Humans
MH  - *Laparoscopy
MH  - Middle Aged
MH  - *Pneumoperitoneum
MH  - Pneumoperitoneum, Artificial
MH  - Prospective Studies
PMC - PMC8606390
OTO - NOTNLM
OT  - Carbon dioxide pneumoperitoneum
OT  - Gasless laparoscopic surgery
OT  - Laparoendoscopic single-site surgery
OT  - Laparoscopic cholecystectomy
OT  - Randomized controlled trial
COIS- The authors declare that they have no conflict of interests.
EDAT- 2021/09/01 06:00
MHDA- 2021/11/24 06:00
PMCR- 2021/08/31
CRDT- 2021/08/31 13:20
PHST- 2021/04/13 00:00 [received]
PHST- 2021/08/21 00:00 [accepted]
PHST- 2021/09/01 06:00 [pubmed]
PHST- 2021/11/24 06:00 [medline]
PHST- 2021/08/31 13:20 [entrez]
PHST- 2021/08/31 00:00 [pmc-release]
AID - 10.1007/s13304-021-01154-9 [pii]
AID - 1154 [pii]
AID - 10.1007/s13304-021-01154-9 [doi]
PST - ppublish
SO  - Updates Surg. 2021 Dec;73(6):2231-2238. doi: 10.1007/s13304-021-01154-9. Epub 
      2021 Aug 31.