Clinical trial NCT03665376: Feasibility and Efficacy of Enhanced Recovery After Surgery (ERAS) on Length of Stay Among Laparotomy Patients at Mbarara Regional Referral Hospital
Official title: Feasibility and Efficacy of Enhanced Recovery After Surgery (ERAS) on Length of Stay Among Laparotomy Patients at Mbarara Regional Referral Hospital, Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparotomy
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly allocated into two arms: intervention arm (ERAS) and control arm
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: From the day of surgical operation up to time 14 days
Secondary outcomes:
measure: Perioperative morbidity and mortality
timeFrame: From the start of surgical intervention to 14 days after discharge from the hospital
measure: Readmission rate
timeFrame: Within 14 days from the day of discharge from the hospital
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara Regional Referral Hospital
Study officials:
affiliation: Kabale University
name: Serge M Tshijuke, MD, MMed
role: PRINCIPAL_INVESTIGATOR
References: