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Clinical Trials/NCT03067519
NCT03067519CompletedNot Applicable

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

University of Rwanda1 site in 1 country62 target enrollmentStarted: October 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
1
Primary Endpoint
hospital stay

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Patients were randomly put in group using sealed envelop.

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients admitted for elective abdominal surgery

Exclusion Criteria

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

Outcomes

Primary Outcomes

hospital stay

Time Frame: within 30 days

numbers of days spent in hospital

Secondary Outcomes

  • Major complications(within 30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ndayizeye Leonard

consultant surgeon, honorary lecturer university of Rwanda

University of Rwanda

Study Sites (1)

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