Fast Track Surgery for Abdominal Surgery in Rwanda

Sponsor
University of Rwanda (Other)
Overall Status
Completed
CT.gov ID
NCT03067519
Collaborator
(none)
62
1
2
4
15.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Fast track surgery
  • Other: Conventional management
N/A

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
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Patients were randomly put in group using sealed envelop.
Primary Purpose:
Treatment
Official Title:
Fast Track Surgery for Abdominal Surgery in Rwanda: a Randomized Controlled Trial
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Dec 31, 2015
Actual Study Completion Date :
Jan 31, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. hospital stay [within 30 days]

    numbers of days spent in hospital

Secondary Outcome Measures

  1. Major complications [within 30 days]

    Major complications were defined as: in-hospital death, intra-abdominal abscess, anastomotic leak, surgical site infection, pneumonia, urinary tract infection, and venous thromboembolism.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 university teaching hospital Kigali Kigali City Rwanda

Sponsors and Collaborators

  • University of Rwanda

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ndayizeye Leonard, consultant surgeon, honorary lecturer university of Rwanda, University of Rwanda
ClinicalTrials.gov Identifier:
NCT03067519
Other Study ID Numbers:
  • URwanda
First Posted:
Mar 1, 2017
Last Update Posted:
Mar 3, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 3, 2017