NCT04543214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 3, 2020

Last Update Submit

September 3, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

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.

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 10, 2020

Study Start

September 1, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations