Fast Track Surgery for Abdominal Surgery in Rwanda

NCT ID: NCT03067519

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-01-31

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.

Conditions

Elective Surgical Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fast track surgery

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

Group Type: EXPERIMENTAL

Fast track surgery

Intervention Type: OTHER

early feeding and mobilization after surgery

Conventional management

usual postoperative care per surgeon

Group Type: ACTIVE_COMPARATOR

Conventional management

Intervention Type: OTHER

Management per the primary surgeon

Interventions

Fast track surgery

early feeding and mobilization after surgery

Intervention Type: OTHER

Conventional management

Management per the primary surgeon

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients admitted for elective abdominal surgery

Exclusion Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rwanda

OTHER

Sponsor Role: lead

Responsible Party

Ndayizeye Leonard

consultant surgeon, honorary lecturer university of Rwanda

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED KISWEZI, MMed

Role: STUDY_DIRECTOR

University of Rwanda

Locations

university teaching hospital Kigali

Kigali, , Rwanda

Countries

Rwanda

Other Identifiers

URwanda

Identifier Type: -

Identifier Source: org_study_id