PMID- 32827645
OWN - NLM
STAT- MEDLINE
DCOM- 20210329
LR  - 20211006
IS  - 1879-1190 (Electronic)
IS  - 1072-7515 (Print)
IS  - 1072-7515 (Linking)
VI  - 231
IP  - 5
DP  - 2020 Nov
TI  - Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low-to 
      Middle-Income Countries: A Phase II Noninferiority Randomized Controlled Study.
PG  - 511-519
LID - S1072-7515(20)32098-6 [pii]
LID - 10.1016/j.jamcollsurg.2020.07.783 [doi]
AB  - BACKGROUND: Minimal access surgery is not available to most people in rural areas 
      of low-to middle-income countries. This leads to an increase in morbidity and 
      economic loss to the poor and marginalized. Gasless laparoscopic (GAL) procedures 
      are possible in rural areas because they can be performed under spinal 
      anesthesia. In most cases, it does not require the logistics of providing gases 
      for pneumoperitoneum and general anesthesia. The current study compares GAL with 
      conventional laparoscopic (COL) operations for general surgical procedures. 
      METHODS: A single-center, nonblinded randomized controlled trial was conducted to 
      evaluate noninferiority of GAL vs COL at a teaching hospital in New Delhi, India. 
      Patients were allocated into 3 groups and underwent minimal access surgery 
      (cholecystectomies and appendectomies). The procedures were performed by 2 
      surgeons choosing randomly between GAL and COL. The data were collected by 
      postgraduates and analyzed by a biostatistician. RESULTS: One hundred patients 
      who met the inclusion criteria were allocated into 2 groups. No significant 
      difference was observed in the mean operating time between the GAL group (52.9 
      minutes) and the COL group (55 minutes) (p = 0.3). Intraoperative vital signs 
      were better in the GAL group (p < 0.05). The postoperative pain score was 
      slightly higher in the GAL group (p = 0.01); however, it did not require 
      additional analgesics. CONCLUSIONS: No significant differences were found between 
      the 2 groups. GAL can be considered as noninferior compared with COL and has the 
      potential to be adopted in low-resource settings.
CI  - Copyright (c) 2020 American College of Surgeons. Published by Elsevier Inc. All 
      rights reserved.
FAU - Mishra, Anurag
AU  - Mishra A
AD  - Department of Surgery, Maulana Azad Medical College, New Delhi, India. Electronic 
      address: anurag.alok@gmail.com.
FAU - Bains, Lovenish
AU  - Bains L
AD  - Department of Surgery, Maulana Azad Medical College, New Delhi, India.
FAU - Jesudin, Gnanaraj
AU  - Jesudin G
AD  - Project GILLS Association of Rural Surgeons of India, Dimapur, Nagaland, India.
FAU - Aruparayil, Noel
AU  - Aruparayil N
AD  - Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, 
      UK.
FAU - Singh, Rajdeep
AU  - Singh R
AD  - Department of Surgery, Maulana Azad Medical College, New Delhi, India.
FAU - Shashi
AU  - Shashi
AD  - Department of Surgery, Maulana Azad Medical College, New Delhi, India.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20200819
PL  - United States
TA  - J Am Coll Surg
JT  - Journal of the American College of Surgeons
JID - 9431305
SB  - IM
CIN - J Am Coll Surg. 2021 May;232(5):799. PMID: 33602612
CIN - J Am Coll Surg. 2021 May;232(5):799-801. PMID: 33612393
CIN - J Am Coll Surg. 2021 Jul;233(1):152-153. PMID: 33962854
CIN - J Am Coll Surg. 2021 Jul;233(1):152. PMID: 34052113
MH  - Adolescent
MH  - Adult
MH  - Appendectomy/*methods
MH  - Cholecystectomy/*methods
MH  - *Developing Countries
MH  - Equivalence Trials as Topic
MH  - Female
MH  - Humans
MH  - India
MH  - Laparoscopy/*methods
MH  - Male
MH  - Minimally Invasive Surgical Procedures
PMC - PMC7435287
EDAT- 2020/08/23 06:00
MHDA- 2021/03/30 06:00
PMCR- 2020/08/19
CRDT- 2020/08/23 06:00
PHST- 2020/06/14 00:00 [received]
PHST- 2020/06/30 00:00 [revised]
PHST- 2020/07/28 00:00 [accepted]
PHST- 2020/08/23 06:00 [pubmed]
PHST- 2021/03/30 06:00 [medline]
PHST- 2020/08/23 06:00 [entrez]
PHST- 2020/08/19 00:00 [pmc-release]
AID - S1072-7515(20)32098-6 [pii]
AID - 10.1016/j.jamcollsurg.2020.07.783 [doi]
PST - ppublish
SO  - J Am Coll Surg. 2020 Nov;231(5):511-519. doi: 10.1016/j.jamcollsurg.2020.07.783. 
      Epub 2020 Aug 19.