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NCT Number: NCT03665376

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

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.

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Key information

Conditions

Laparotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mbarara Regional Referral Hospital

Mbarara, 00256, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate drink load

Dietary Supplement

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

Other names: 5% Dextrose orally

Enhanced recovery after surgery (ERAS)

Combination Product

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.

Other names: Fast Track Surgery, Multimodal Rehabilitation

Primary outcomes

  1. Length of hospital stay

    Time frame: From the day of surgical operation up to time 14 days

    It is the duration of a single episode of hospitalization measured as time .

Secondary outcomes

  1. Perioperative morbidity and mortality

    Time frame: From the start of surgical intervention to 14 days after discharge from the hospital

    Adverse events or death occurring during or 14 days after the surgical operation

  2. Readmission rate

    Time frame: Within 14 days from the day of discharge from the hospital

    Admission of a patient in the hospital within 14 days after discharge

Sponsors and collaborators

Lead sponsor

Mbarara University of Science and Technology

Other

Registry information

Official study title

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

Acronym: ERAS-Lap

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2018
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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