The effect of the enhanced recovery after surgery (ERAS) program on length of stay among abdominal surgery patients at Mbarara Regional Referral Hospital, Uganda
| ISRCTN | ISRCTN62342149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62342149 |
| ClinicalTrials.gov number | NCT03665376 |
- Submission date
- 03/03/2020
- Registration date
- 09/03/2020
- Last edited
- 09/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Namugongo
Nsawo Community Estate
Valley View lane
Kampala
37844
Uganda
 ORCID ID |
0000-0001-7198-4033 |
|---|---|
| Phone | +256 772456587 |
| sergetshijuke@yahoo.fr |
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Feasibility and efficacy of Enhanced Recovery After Surgery (ERAS) on length of stay among laparotomy patients at Mbarara Regional Referral Hospital, Uganda |
| Study acronym | ERAS |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2016 |
| Completion date | 15/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 33 |
| Key inclusion criteria | 1. 18 years of age and above 2. Scheduled for non-emergency laparotomy |
| Key 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 |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 30/07/2017 |
Locations
Countries of recruitment
- Uganda
Study participating centre
Mbarara
00256
Uganda
Sponsor information
University/education
Kabale Highway
Mbarara
P.O. Box 1410
Uganda
| Phone | +256 485433795 |
|---|---|
| sec.rec@must.ac.ug | |
| Website | http://www.must.ac.ug/ |
"ROR" |
https://ror.org/01bkn5154 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Editorial Notes
09/03/2020: Trial’s existence confirmed by Faculty of Medicine Research Committee (FRC) at Mbarara University of Science and Technology (MUST)
