Clinical trial NCT03191318: Comparison of Enhanced Recovery After Surgery (ERAS) Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy
Official title: Randomized Control Trial to Compare the Outcomes of Enhanced Recovery After Surgery (ERAS) Pathway and Standard Recovery Pathway After Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: ERAS
Enhanced recovery after sugery in bariatric surgery
sleeve gastrectomy
Lead sponsor: GEM Hospital & Research Center
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing laparoscopic sleeve gastrectomy during this study period

Exclusion Criteria:

* 1. Redo procedures 2. ASA III and above status 3. Previous major upper abdominal surgeries 4. Not willing to participate

Primary outcomes:
measure: Hospital stay
timeFrame: 7 days
Secondary outcomes:
measure: Pain score
timeFrame: Within 72 hours of surgery
measure: Operative time
timeFrame: Within 24 hours, in minutes
measure: Analgesic requirement
timeFrame: Within 72 hours
measure: Complication rate
timeFrame: Within 30 days
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: Gem Hospital and Research Centre
state: Tamil Nadu
Study officials:
affiliation: GEM Hospital & Research centre
name: C Palanivelu, MS, MCh
role: STUDY_CHAIR
affiliation: GEM Hospital and Research centre
name: P Praveen Raj, MS, DNB
role: STUDY_DIRECTOR
affiliation: GEM Hospital & Research centre
name: M S Prabhakaran, DA
role: PRINCIPAL_INVESTIGATOR
affiliation: GEM Hospital & Research centre
name: Siddhartha Bhattacharya, MS, DNB, FNB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.