Condition category
Surgery
Date applied
03/03/2020
Date assigned
09/03/2020
Last edited
09/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

http://www.must.ac.ug/

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

Publication citations

Additional files

Editorial Notes

09/03/2020: Trial’s existence confirmed by Faculty of Medicine Research Committee (FRC) at Mbarara University of Science and Technology (MUST)