Feasibility and Efficacy of Enhanced Recovery After Surgery (ERAS) on Length of Stay Among Laparotomy Patients at Mbarara Regional Referral Hospital

Laparotomy Clinical Trial

— ERAS-Lap  

Official title:

Feasibility and Efficacy of Enhanced Recovery After Surgery (ERAS) on Length of Stay Among Laparotomy Patients at Mbarara Regional Referral Hospital, Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665376
• Other study ID #: MUST16/2017
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: August 15, 2017

Study information

• Verified date: September 2018
• Source: Mbarara University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main goal of ERAS is to enhance the recovery of patients, and this has secondary effects, such reduced length of hospital stay, minimal postoperative complications and lessen readmission rates. ERAS protocols have been shown to be feasible and safe across the world. Although it has been shown to be effective in the developed settings and can potentially reduce the length of hospital stay, and the cost of healthcare in the perioperative period. The multimodal program of ERAS has been less implemented in the low and middle income African countries. Studies done outside Uganda (Egypt and South Africa) have demonstrated that ERAS program can be feasible and yields favorable outcomes in patients.

Description:

The efficacy of ERAS has been demonstrated in resource rich settings but limited evidence is available from resource poor settings. The aim of this study was to determine the feasibility and test efficacy of ERAS in reducing length of post-operative hospital stay and the incidence of postoperative complications compared to the standard of care as the control group.

33 participants above 18 years of age, undergoing laparotomy, were randomly assigned to an intervention (ERAS) arm or to a control (standard surgical care) arm at Mbarara Regional Referral Hospital in Uganda. The ERAS and the control arm had 16 and 17 patients respectively, followed-up 14 days after surgery.

Patients in the ERAS arm had 2.4 days (SD 0.7) of post-operative hospital stay shorter than those in the control arm, p=0.0025 (4.1±0.2 vs 6.5±0.6 respectively). 18.8% of patients in the control arm developed post-operative complications compared to 5.9% in the ERAS arm (Statistical insignificance, p=0.34). ERAS patients passed flatus eight hours earlier than patients in the control arm, and mobilisation out of bed happened 12 hours earlier in the ERAS group p value=0.4.

ERAS is feasible at Mbarara Regional Referral Hospital, and it leads to reduced hospital stay duration but not post-operative complications in laparotomy cases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 15, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• We enrolled adult patients, 18 years of age and above, scheduled for non-emergency laparotomy.

Exclusion Criteria:

• Patients with age less than 18 years

• Pregnant patients

• Emergency Laparotomy

• American Society of Anesthesiologists (ASA) physical status score greater than 3

• Surgeries other than elective gastrointestinal laparotomy

• Diabetes patients

Related Conditions & MeSH terms

• Laparotomy

Intervention

Dietary Supplement:
• Carbohydrate drink load
Administration of 5% Dextrose orally as a carbohydrate drink load two hours before surgery and as an oral sips eight hours after the surgery.

Combination Product:
• Enhanced Recovery After Surgery (ERAS)
The ERAS intervention consisted of exposing patients to ERAS protocol of care as described by the ERAS Society® for the entire perioperative period. However, some of these ERAS protocols were modified to our local resources and requirements.

Locations

Country	Name	City	State
Uganda	Mbarara Regional Referral Hospital	Mbarara

Sponsors (1)

Lead Sponsor	Collaborator
Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	It is the duration of a single episode of hospitalization measured as time .	From the day of surgical operation up to time 14 days
Secondary	Perioperative morbidity and mortality	Adverse events or death occurring during or 14 days after the surgical operation	From the start of surgical intervention to 14 days after discharge from the hospital
Secondary	Readmission rate	Admission of a patient in the hospital within 14 days after discharge	Within 14 days from the day of discharge from the hospital