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

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ClinicalTrials.gov Identifier: NCT03665376
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Mbarara University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Laparotomy Dietary Supplement: Carbohydrate drink load Combination Product: Enhanced Recovery After Surgery (ERAS) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were randomly allocated into two arms: intervention arm (ERAS) and control arm
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Feasibility and Efficacy of Enhanced Recovery After Surgery (ERAS) on Length of Stay Among Laparotomy Patients at Mbarara Regional Referral Hospital, Uganda
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : August 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ERAS arm
Preoperative: Counseling and education about the ERAS program; Oral intake until 6 hours before the surgery; Carbohydrate drinks load; No mechanical bowel preparation; Antithrombotic prophylaxis (Tinzaparin 3500 IU) Intraoperative: Spinal anaesthesia (15 mg hyperbaric Bupivacaine + 200mcg intrathecal Morphine); Intravenous Ceftriaxone 2g, Metronidazole 500mg / Gentamycin 160mg, Ondansetron 8mg and Dexamethasone 8mg; Crystalloid fluid 10 to 20ml/Kg; Adrenaline 200mcg in each 500 ml of intravenous fluid; Avoidance of abdominal drains; Postoperative: Early oral intake; Nasogastric tube and urinary catheter removed immediately after the surgery; Early enteral nutrition; Chewing gum for 2 to 4 hours after surgery; Oral sips 8 hours postoperatively; Intravenous fluids discontinued at four hours after transfer to the ward.
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.
Other Name: 5% Dextrose orally

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.
Other Names:
  • Fast Track Surgery
  • Multimodal Rehabilitation

No Intervention: Control arm
Preoperative: No carbohydrate drink loads, no antithrombotic prophylaxis; Mechanical bowel preparation as needed; Spinal anaesthesia, fluid therapy and antibiotherapy done according to standard hospital practice. The urinary catheter and drains were removed at the discretion of the surgeon. Postoperative: Enteral feeding delayed by the auscultation of bowel sounds. The standard hospital practices involve keeping active the nasogastric tube, fasting patients postoperative, strict bed rest… Pain control was managed with medication of choice by surgeon and anesthesiologist.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665376


Locations
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Uganda
Mbarara Regional Referral Hospital
Mbarara, Uganda, 00256
Sponsors and Collaborators
Mbarara University of Science and Technology
Investigators
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Principal Investigator: Serge M Tshijuke, MD, MMed Kabale University

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Responsible Party: Mbarara University of Science and Technology
ClinicalTrials.gov Identifier: NCT03665376     History of Changes
Other Study ID Numbers: MUST16/2017
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No