Fast Track Surgery for Abdominal Surgery in Rwanda

Elective Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067519
• Other study ID #: URwanda
• Status: Completed
• Phase: N/A
• First received: February 21, 2017
• Last updated: March 1, 2017
• Start date: October 2015
• Est. completion date: January 31, 2016

Study information

• Verified date: March 2017
• Source: University of Rwanda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 31, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• patients admitted for elective abdominal surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Elective Surgical Procedures

Intervention

Other:
• Fast track surgery
early feeding and mobilization after surgery
• Conventional management
Management per the primary surgeon

Locations

Country	Name	City	State
Rwanda	university teaching hospital Kigali	Kigali City

Sponsors (1)

Lead Sponsor	Collaborator
University of Rwanda

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital stay	numbers of days spent in hospital	within 30 days
Secondary	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