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

NCT03665376 | Completed

• 1 other identifier: MUST16/2017
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparotomy

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

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

  From the day of surgical operation up to time 14 days

Secondary Outcomes (2)

• Perioperative morbidity and mortality

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

• Readmission rate

  Within 14 days from the day of discharge from the hospital

Study Arms (2)

ERAS arm

EXPERIMENTAL

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; Combination Product: Enhanced Recovery After Surgery (ERAS)

Control arm

NO INTERVENTION

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.

Interventions

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.

Also known as: 5% Dextrose orally

ERAS arm

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.

Also known as: Fast Track Surgery, Multimodal Rehabilitation

ERAS arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We enrolled adult patients, 18 years of age and above, scheduled for non-emergency laparotomy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, 00256, Uganda

Location

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Officials

• Serge M Tshijuke, MD, MMed

  Kabale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly allocated into two arms: intervention arm (ERAS) and control arm

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 11, 2018
• Study Start: June 1, 2017
• Primary Completion: July 30, 2017
• Study Completion: August 15, 2017
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

UG (1)