Gem Hospital and Research Centre
Coimbatore, Tamil Nadu, 641045, India
NCT Number: NCT03191318
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Coimbatore, Tamil Nadu, 641045, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ERAS pathway after laparoscopic sleeve gastrectomy
Other names: Fast track pathway
Standard pathway after laparoscopic sleeve gastrectomy
Other names: Coventional pathway
Time frame: 7 days
Postoperative hospital stay of patients
Time frame: Within 72 hours of surgery
Postoperative pain score
Time frame: Within 24 hours, in minutes
Time taken to perform surgery
Time frame: Within 72 hours
Post operative cumulative analgesic requirement
Time frame: Within 30 days
Post operative complications rate
GEM Hospital & Research Center
Other
Randomized Control Trial to Compare the Outcomes of Enhanced Recovery After Surgery (ERAS) Pathway and Standard Recovery Pathway After Laparoscopic Sleeve Gastrectomy
Acronym: BARI-ERAS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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