Plain English Summary
Background and study aims
A laparotomy is a surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity.
Enhanced recovery after surgery (ERAS) is a model of care for elective surgery that combines elements of care to form a structured pathway to decrease physical issues after surgery, which may lead to complications and death during and after the surgery, and increase the length of hospital stay. The main goal of ERAS is to enhance the recovery of patients and thus reduce the length of hospital stay, minimize cost, complications and readmission rates after surgery. ERAS is being safely implemented across the world. But it has not been implemented in the low-income African countries. There is need to examine the feasibility of the ERAS in our settings. Studies done outside Uganda (Egypt and South Africa) have demonstrated that ERAS program can be feasible and yields favorable outcomes in patients. This study will help to improve on the management and treatment of patients before, during and after operation.
Who can participate?
Patients 18 years of age and above, scheduled for non-emergency laparotomy.
What does the study involve?
Participants will be randomly allocated to receive the ERAS care pathway or treatment as usual for up to 14 days after their surgery.
What are the possible benefits and risks of participating?
The benefits of participating: This study will help to improve on the management and treatment of patients before, during and after operation. Participants will also be given counselling and health education about their sickness.
The Risks: Minimal to mild pain may be experienced during mobilization after operation.
Where is the study run from?
Mbarara regional referral Hospital, Uganda
When is the study starting and how long is it expected to run for?
June 2017 to August 2017
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Serge Mudipanu Tshijuke
sergetshijuke@yahoo.fr
Trial website
Contact information
Type
Scientific
Primary contact
Dr Serge Mudipanu Tshijuke
ORCID ID
http://orcid.org/0000-0001-7198-4033
Contact details
Namugongo
Nsawo Community Estate
Valley View lane
Kampala
37844
Uganda
+256 772456587
sergetshijuke@yahoo.fr
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
NCT03665376
Protocol/serial number
Nil known
Study information
Scientific 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
Study hypothesis
1. Is the ERAS program feasible at MRRH?
2. Is there any difference in the length of post-operative hospital stay that can occur with the implementation of ERAS?
3. Which perioperative complications may arise during implementation of ERAS in laparotomies?
Ethics approval
Approved 06/04/2017, Faculty of Medicine Research Committee (FRC) at Mbarara University of Science and Technology (MUST) (P.O. Box 1410, Mbarara – Uganda; +256-485-433-795; sec.rec@must.ac.ug), ref: MUREC 1/7
Study design
Single-centre interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Laparotomy
Intervention
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.
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.
Numbers for randomisation into groups were generated and kept in sealed envelopes. Neither the investigators nor the study participants were blinded.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Length of hospital stay from the day of surgical operation up to 14 days
Secondary outcome measures
1. Adverse events or death occurring during or 14 days after the surgical operation
2. Readmission rate measured as admission of a patient in the hospital within 14 days after discharge
Overall trial start date
01/07/2016
Overall trial end date
15/08/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 18 years of age and above
2. Scheduled for non-emergency laparotomy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Total final enrolment
33
Participant exclusion criteria
1. Pregnancy
2. Admitted for emergency laparotomy, or had ASA physical status score greater than III
3. Scheduled for other surgery other than elective gastrointestinal laparotomy
4. Diabetic patients
Recruitment start date
01/06/2017
Recruitment end date
30/07/2017
Locations
Countries of recruitment
Uganda
Trial participating centre
Mbarara regional referral Hospital
Kabale highway
Mbarara
00256
Uganda
Sponsor information
Organisation
Mbarara University of Science and Technology
Sponsor details
Kabale Highway
Mbarara
P.O. Box 1410
Uganda
+256 485433795
sec.rec@must.ac.ug
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
01/06/2020
Participant level data
Available on request
Basic results (scientific)
Publication list