Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03191318
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2017-06-15
Brief Title:
Comparison of Enhanced Recovery After Surgery ERAS Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy
Sponsor:
GEM Hospital Research Center
Organization:
GEM Hospital Research Center
Study Overview
Official Title:
Randomized Control Trial to Compare the Outcomes of Enhanced Recovery After Surgery ERAS Pathway and Standard Recovery Pathway After Laparoscopic Sleeve Gastrectomy
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BARI-ERAS
Brief Summary:
The aim of this study is to compare two postoperative recovery pathways namely enhanced recovery after surgery ERAS pathway and conventional recovery pathway after laparoscopic sleeve gastrectomy with respect to outcomes including hospital stay postoperative pain and other postoperative outcomes
Detailed Description:
The Enhanced recovery after surgery ERAS pathway initially introduced for colorectal surgery is an evidence based perioperative pathway which has resulted in earlier recovery less pain and lower complication rates Bariatric surgical patients without severe co-morbidities are good candidates for ERAS pathway but the application of ERAS concepts has been limited in this field specially in Asia
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None