Comparison of Enhanced Recovery After Surgery (ERAS) Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy
NCT ID: NCT03191318
Last Updated: 2018-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-09-01
2018-08-01
Brief Summary
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Detailed Description
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Although the current literature shows that 2 randomized clinical trials (RCT) have been performed for application of ERAS in bariatric surgery, data is still scarce as per outcomes with respect to postoperative pain and analgesic usage. One of the RCTs has compared with historical controls and both the RCTs have not clearly defined their conventional standard pathways. In this study, the investigators have clearly defined both ERAS pathway and standard pathway leaving no ambiguity.
This study is a prospective, randomized, parallel group trial comparing ERAS pathway and standard pathway after laparoscopic sleeve gastrectomy in relation to the hospital stay, postoperative pain, complications and other perioperative parameters.
This is a single institute based trial, being conducted at GEM hospital and research centre, Coimbatore, TN, India. The trial has been approved by the GEM Hospital ethical committee.
In this trial, the investigators are planning to enroll participants with morbid obesity planned to undergo laparoscopic sleeve gastrectomy. After full assessment, informed consent, these participants will be randomised using computer generated random numbers either into ERAS pathway group or into Standard pathway group.
All the intraoperative and perioperative details with respect to anaesthetic drugs usage, intravenous fluid requirement, time to ambulation, time to oral liquids, postoperative pain score, analgesic requirement and hospital stay will be recorded in the proforma.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ERAS pathway
Laparoscopic sleeve gastrectomy with ERAS pathway
ERAS pathway
ERAS pathway after laparoscopic sleeve gastrectomy
Standard pathway
Laparoscopic sleeve gastrectomy with standard pathway
Standard pathway
Standard pathway after laparoscopic sleeve gastrectomy
Interventions
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ERAS pathway
ERAS pathway after laparoscopic sleeve gastrectomy
Standard pathway
Standard pathway after laparoscopic sleeve gastrectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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GEM Hospital & Research Center
OTHER
Responsible Party
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Principal Investigators
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C Palanivelu, MS, MCh
Role: STUDY_CHAIR
GEM Hospital & Research centre
P Praveen Raj, MS, DNB
Role: STUDY_DIRECTOR
GEM Hospital and Research centre
M S Prabhakaran, DA
Role: PRINCIPAL_INVESTIGATOR
GEM Hospital & Research centre
Siddhartha Bhattacharya, MS, DNB, FNB
Role: PRINCIPAL_INVESTIGATOR
GEM Hospital & Research centre
Locations
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Gem Hospital and Research Centre
Coimbatore, Tamil Nadu, India
Countries
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References
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Pimenta GP, Capellan DA, de Aguilar-Nascimento JE. Sleeve Gastrectomy With or Without a Multimodal Perioperative Care. A Randomized Pilot Study. Obes Surg. 2015 Sep;25(9):1639-46. doi: 10.1007/s11695-015-1573-2.
Lemanu DP, Singh PP, Berridge K, Burr M, Birch C, Babor R, MacCormick AD, Arroll B, Hill AG. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg. 2013 Mar;100(4):482-9. doi: 10.1002/bjs.9026. Epub 2013 Jan 21.
Prabhakaran S, Misra S, Magila M, Kumar SS, Kasthuri S, Palanivelu C, Raj PP. Randomized Controlled Trial Comparing the Outcomes of Enhanced Recovery After Surgery and Standard Recovery Pathways in Laparoscopic Sleeve Gastrectomy. Obes Surg. 2020 Sep;30(9):3273-3279. doi: 10.1007/s11695-020-04585-2.
Other Identifiers
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BARI-01
Identifier Type: -
Identifier Source: org_study_id
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