Clinical trial NCT04543214: Outcome of Enhanced Recovery After Surgery (ERAS) Protocols in Patients Undergoing Small Bowel Surgery
Official title: Outcome of Enhanced Recovery After Surgery (ERAS) Protocols in Patients Undergoing Small Bowel Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enhanced Recovery After Surgery
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2020-09-10
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: 2 weeks
measure: Postoperative wound infection
timeFrame: 2 weeks
measure: Anastomotic leakage
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Institute of Medical Sciences
state: Punjab
Study officials:
References: