Fast Track Surgery for Abdominal Surgery in Rwanda

Fast Track Surgery for Abdominal Surgery in Rwanda: a Randomized Controlled Trial

Fast Track Surgery (FTS) was started in colorectal surgery, but was later applied to other surgical fields. Core elements include epidural or regional anaesthesia, perioperative fluid management, minimally invasive surgical techniques, pain control, and early mobilization and feeding. Beneficial effects of FTS include reduced costs, early hospital discharge, and increased availability of hospital beds.The main aim of this study was to explore the efficacy of FTS in the Rwandan surgical setting and to demonstrate the benefits of FTS.

it is study comparing the management of surgical patients using traditional management and fast track surgery. the study was done on patients undergoing elective abdominal surgery only

Study Overview

• Status: Completed
• Conditions: Elective Surgical Procedures
• Intervention / Treatment: Other: Fast track surgery; Other: Conventional management

Detailed Description

Fast track surgery (FTS) uses a multifaceted approach to reduce the stress response to surgery, thereby improving outcomes and decreasing length of hospital stay. The core elements of FTS include: epidural or regional anesthesia, peri-operative fluid management, minimally invasive techniques, optimal pain control, early initiation of oral feeding and early mobilization. The combination of these approaches has led to a significant reduction in complication rates, morbidity and mortality rates, duration of hospital stay and costs of hospitalization, and greatly improved postoperative recovery The main aim of this study was to explore the efficacy of FTS in the Rwandan surgical setting and to demonstrate the benefits of FTS.

This randomized control trial was conducted in CHUK over a period of three months (October - December, 2015). For patients in the FTS arm, the study investigator would assess patients on a daily basis and work with the primary surgical team. The study investigator would prompt the primary surgical team for early feeding, mobilization, pain control and fluid management recommendations.

Data were collected on variables including postoperative analgesia, mobilisation, resuming oral feeding, hospital stay and complications. The primary outcome was duration of postoperative hospital stay and secondary outcome was major complications.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Rwanda
  • Kigali City, Rwanda
    • university teaching hospital Kigali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients admitted for elective abdominal surgery

Exclusion Criteria:

• patients with comorbidity, American Society of Anesthesiologists score greater than 2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fast track surgery; Intervention: Fast track surgery patients underwent early feeding and mobilization after surgery	Other: Fast track surgery; early feeding and mobilization after surgery
Active Comparator: Conventional management; usual postoperative care per surgeon	Other: Conventional management; Management per the primary surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital stay	numbers of days spent in hospital	within 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major complications	Major complications were defined as: in-hospital death, intra-abdominal abscess, anastomotic leak, surgical site infection, pneumonia, urinary tract infection, and venous thromboembolism.	within 30 days

Collaborators and Investigators

• Sponsor: University of Rwanda
• Investigators: Study Director: AHMED KISWEZI, MMed, University of Rwanda

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): January 31, 2016

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: URwanda

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No