NCT03067519

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

February 21, 2017

Last Update Submit

March 1, 2017

Conditions

Elective Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • hospital stay

    numbers of days spent in hospital

    within 30 days

Secondary Outcomes (1)

  • Major complications

    within 30 days

Study Arms (2)

Fast track surgery

EXPERIMENTAL

Intervention: Fast track surgery patients underwent early feeding and mobilization after surgery

Other: Fast track surgery

Conventional management

ACTIVE COMPARATOR

usual postoperative care per surgeon

Other: Conventional management

Interventions

Fast track surgeryOTHER

early feeding and mobilization after surgery

Fast track surgery
Conventional managementOTHER

Management per the primary surgeon

Conventional management

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted for elective abdominal surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university teaching hospital Kigali

Kigali, Rwanda

Location

Study Officials

  • AHMED KISWEZI, MMed

    University of Rwanda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients were randomly put in group using sealed envelop.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant surgeon, honorary lecturer university of Rwanda

Study Record Dates

First Submitted

February 21, 2017

First Posted

March 1, 2017

Study Start

October 1, 2015

Primary Completion

December 31, 2015

Study Completion

January 31, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

RW(1)