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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03665376
Other study ID # MUST16/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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