Enhanced Recovery After SurgeryNCT04543214
Outcome of Enhanced Recovery After Surgery (ERAS) Protocols in Patients Undergoing Small Bowel Surgery
An observational study of Enhanced Recovery After Surgery, run by Services Hospital, Lahore at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Enhanced Recovery After Surgery
- What is being tested?
- Enhanced recovery after surgery
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2017to 31 Aug 2019
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Elective surgery of small bowel resection
- Benign and malignant non metastatic disease
- ASA-I and ASA-II patients
Who cannot join
- Uncontrolled diabetes
- Metastatic disease
- Malnourished patients
- Chronic renal Failure
- Chronic liver disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences
Lahore, Punjab Province, 54000
About this study
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.
Read the 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.
- Conditions
- Enhanced Recovery After Surgery
- Being tested
- Enhanced recovery after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surgeryOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Number of days patients stays in hospital
Measured: 2 weeks
Postoperative wound infection
Number of patients developing erythema and purulent discharge from wound site
Measured: 2 weeks
Anastomotic leakage
Number of patients developing leak from anastomotic site
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Sep 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543214
- Sponsor's protocol ID
- s15
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Enhanced Recovery After Surgery (ERAS) Protocols in Patients Undergoing Small Bowel Surgery
- ClinicalTrials.gov ID
- NCT04543214
- Acronym / sponsor ID
- s15
- Conditions
- Enhanced Recovery After Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Elective surgery of small bowel resection
- Benign and malignant non metastatic disease
- ASA-I and ASA-II patients
Key exclusion criteria (5 listed)
- Uncontrolled diabetes
- Metastatic disease
- Malnourished patients
- Chronic renal Failure
- Chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery after surgeryEnhanced 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. | Other | – |
Primary outcome
Length of hospital stay
Time frame: 2 weeks
Number of days patients stays in hospital
Postoperative wound infection
Time frame: 2 weeks
Number of patients developing erythema and purulent discharge from wound site
Anastomotic leakage
Time frame: 4 weeks
Number of patients developing leak from anastomotic site
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enhanced Recovery After Surgery, run by Services Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.