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

Enhanced Recovery After Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543214
• Other study ID #: s15
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: September 2020
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery

Intervention

Other:
• Enhanced recovery after surgery
Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response after surgery. It benefits patient by reducing complications and enhancing recovery and saves resources for the health care system. In this concept, surgeons work collaboratively with anesthesiologist, nurses, nutritionists and physical therapists to develop and manage the perioperative care.

Locations

Country	Name	City	State
Pakistan	Services Institute of Medical Sciences	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

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