Fast Track Surgery for Abdominal Surgery in Rwanda | NCT03067519

Studies
Fast Track Surgery for Abdominal Surgery in Rwanda

NCT03067519

Sponsor

University of Rwanda

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Elective Surgical Procedures

Interventions

Fast track surgery
Conventional management

Countries

Rwanda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015Actual

Primary Completion Date

Dec 31, 2015Actual

Completion Date

Jan 31, 2016Actual

First Submitted Date

Feb 21, 2017

First Submission Date that Met QC Criteria

Feb 24, 2017

First Posted Date

Mar 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2017

Last Update Posted Date

Mar 3, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ndayizeye Leonard, consultant surgeon, honorary lecturer university of Rwanda, University of RwandaPrincipal Investigator

Lead Sponsor

University of RwandaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fast track surgery	Other	early feeding and mobilization after surgery	Fast track surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients admitted for elective abdominal surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AHMED KISWEZI, MMed	University of Rwanda	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
university teaching hospital Kigali		Kigali			Rwanda

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided