Outcome of Enhanced Recovery After Surgery (ERAS) Protocols in Patients Undergoing Small Bowel Surgery

It was a descriptive case series conducted it Department of Surgery, Services Hospital, Lahore. Total of 140 patients who underwent small bowel resection anastomosis were subjected to ERAS protocols.The objective of this study was to determine the outcome of applying enhanced recovery after surgery (ERAS) protocols in patients undergoing small bowel surgery.

Study Overview

• Status: Completed
• Conditions: Enhanced Recovery After Surgery
• Intervention / Treatment: Other: Enhanced recovery after surgery

Detailed Description

It was a descriptive case series study conducted at Surgical Unit II, Services Hospital, Lahore. Sample size of 140 cases was calculated with 95% confidence level, 4.5% margin of error while taking expected percentage of anastomotic leakage in 8% cases passed through Enhanced Recovery after Surgery protocole.9 Patients were selected by Non-probability Purposive Sampling. Patients of both sex groups with ages between 20-45 years. Having elective surgery of small bowel resection and anastomosis admitted through OPD were included in the study. Patient with co-morbid conditions falling in ASA Class III or greater and patients with metastatic tumours of small bowel were excluded from the study. 140 patients presenting in the surgical outdoor of Services Hospital, Lahore who fulfilled the inclusion criteria were included in the study. A detailed history was taken including demographic data (age, gender and address). Patients were requested to sign an informed consent after explaining them the details of the study. ERAS protocols were implemented. Patients were followed after 4 weeks post-operatively in outdoor and outcome were measured in terms of length of hospital stay, post-operative wound infection, anastomotic leakage and death. All the surgeries and the follow ups were performed by the consultant in charge of the unit to eliminate bias. Confounding variables were controlled by exclusion. All the data was recorded into the attached proforma.(annexed). All the collected data was entered into SPSS version 10. Numerical variables like age and length of hospital stay have been presented by mean ±SD. Categorical variables i-e gender, post-operative wound infection, anastomotic leakage and mortality have been presented by frequency and percentage. Data has been stratified for anastomotic leakage to deal with effect modifier. Chi square test has been applied post stratification with P-value ≤0.05 taken as significant.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Services Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Sample size of 140 cases was calculated with 95% confidence level, 4.5% margin of error while taking expected percentage of anastomotic leakage in 8% cases passed through Enhanced Recovery after Surgery protocole.

Description

Inclusion Criteria:

• Elective surgery of small bowel resection
• Benign and malignant non metastatic disease
• ASA-I and ASA-II patients

Exclusion Criteria:

• Uncontrolled diabetes
• Metastatic disease
• Malnourished patients
• Chronic renal Failure
• Chronic liver disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Number of days patients stays in hospital	2 weeks
Postoperative wound infection	Number of patients developing erythema and purulent discharge from wound site	2 weeks
Anastomotic leakage	Number of patients developing leak from anastomotic site	4 weeks

Collaborators and Investigators

• Sponsor: Services Hospital, Lahore

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: S15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No