Comparison of Enhanced Recovery After Surgery (ERAS) Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy (BARI-ERAS)
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|ClinicalTrials.gov Identifier: NCT03191318|
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Other: ERAS pathway Other: Standard pathway||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Control Trial to Compare the Outcomes of Enhanced Recovery After Surgery (ERAS) Pathway and Standard Recovery Pathway After Laparoscopic Sleeve Gastrectomy|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||July 1, 2018|
|Actual Study Completion Date :||August 1, 2018|
Active Comparator: ERAS pathway
Laparoscopic sleeve gastrectomy with ERAS pathway
Other: ERAS pathway
ERAS pathway after laparoscopic sleeve gastrectomy
Other Name: Fast track pathway
Active Comparator: Standard pathway
Laparoscopic sleeve gastrectomy with standard pathway
Other: Standard pathway
Standard pathway after laparoscopic sleeve gastrectomy
Other Name: Coventional pathway
- Hospital stay [ Time Frame: 7 days ]Postoperative hospital stay of patients
- Pain score [ Time Frame: Within 72 hours of surgery ]Postoperative pain score
- Operative time [ Time Frame: Within 24 hours, in minutes ]Time taken to perform surgery
- Analgesic requirement [ Time Frame: Within 72 hours ]Post operative cumulative analgesic requirement
- Complication rate [ Time Frame: Within 30 days ]Post operative complications rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191318
|Gem Hospital and Research Centre|
|Coimbatore, Tamil Nadu, India, 641045|
|Study Chair:||C Palanivelu, MS, MCh||GEM Hospital & Research centre|
|Study Director:||P Praveen Raj, MS, DNB||GEM Hospital and Research centre|
|Principal Investigator:||M S Prabhakaran, DA||GEM Hospital & Research centre|
|Principal Investigator:||Siddhartha Bhattacharya, MS, DNB, FNB||GEM Hospital & Research centre|