SurgeryNCT03986450
ERAS Protocol in Laparoscopic Hysterectomy
A study testing Enhanced recovery after surge(ERAS) protocol in people with Surgery, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay. This study aimed to investigate the impact of implementing ERAS protocols on healthcare costs in patients undergoing a laparoscopic hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Surgery
- What is being tested?
- Enhanced recovery after surge(ERAS) protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2019to 18 Jul 2019
- Phase
- Interventional
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be scheduled for laparoscopic hysterectomy
Who cannot join
- American Society of Anesthesiologists (ASA) class IV
- Development of complications during surgery
- Body mass index > 40 kg/m2
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital,
Istanbul, Please Enter the State Or Province, 34005
About this study
Official title: The Impact of Implementing ERAS Protocol on Healthcare Costs in Patients Undergoing Laparoscopic Hysterectomy
ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay. This study aimed to investigate the impact of implementing ERAS protocols on healthcare costs in patients undergoing a laparoscopic hysterectomy.
Read the detailed description
ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay in various kinds of surgical procedures. This study aimed to investigate whether ERAS protocol has an impact on healthcare costs in patients undergoing a laparoscopic hysterectomy. Patients scheduled for laparoscopic hysterectomy will be allocated to one of the study groups: ERAS group patients will receive ERAS protocol during the perioperative period; Conventional care groups will undergo standard abdominal hysterectomy without the implementation of ERAS protocol. The groups will be compared with respect to the length of hospital stay, rehospitalizations, and healthcare costs.
- Conditions
- Surgery
- Being tested
- Enhanced recovery after surge(ERAS) protocol
- Keywords
- Enhanced recovery after surgery, Laparoscopic hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surge(ERAS) protocolOther
The components of ERAS multidisciplinary pathway concerning preoperative, operative, and postoperative period are as follows:
- Preoperative care: Counseling before hospital admission Fluid, and carbohydrate loading Avoiding prolongation of the fasting period Avoiding bowel preparation or its application only in selective cases Application of antibiotic prophylaxis Application of thromboprophylaxis
- Perioperative care:
Use of short-acting anesthetic agents Application of midthoracic, epidural anesthesia/analgesia Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia
Postoperative care:
Application of midthoracic, epidural anesthesia/analgesia Prevention of nausea, and vomiting Refraining from salt, and water overload Earlier removal of catheters Initiation of oral intake at an early period Use of nonopioid oral analgesics/NSAIDs Early mobilization
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Active comparator | Patients in this group will receive ERAS protocol preoperatively, perioperatively and postoperatively. Receives: Other: Enhanced recovery after surge(ERAS) protocol |
| Control | No intervention | This group of patients will not receive ERAS care and will undergo a standard laparoscopic hysterectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare costs
Hospital costs will be obtained from the accounting office of the hospital
Measured: Up to one month
Secondary outcomes (1)
Length of stay
Length of hospital stay
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start20 Jun 2019 (estimated)
- Primary completion15 Jul 2019 (estimated)
- Study completion18 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysu Akca, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Aysu Akca, MD, Principal investigator, Kanuni Sultan Suleyman Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986450
- Sponsor's protocol ID
- AYSUAKCA2
- Status last verified
- Jun 2019
- First submitted
- 23 May 2019
- Last updated
- 14 Jun 2019
- Results posted
- 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 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Implementing ERAS Protocol on Healthcare Costs in Patients Undergoing Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT03986450
- Acronym / sponsor ID
- AYSUAKCA2
- Conditions
- Surgery
- Keywords
- Enhanced recovery after surgery, Laparoscopic hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Jun 2019 (estimated)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 18 Jul 2019 (estimated)
- First posted
- 14 Jun 2019 (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.
ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay. This study aimed to investigate the impact of implementing ERAS protocols on healthcare costs in patients undergoing a laparoscopic hysterectomy.
Detailed description
ERAS protocol has been shown to improve patient comfort and reduce the length of hospital stay in various kinds of surgical procedures. This study aimed to investigate whether ERAS protocol has an impact on healthcare costs in patients undergoing a laparoscopic hysterectomy. Patients scheduled for laparoscopic hysterectomy will be allocated to one of the study groups: ERAS group patients will receive ERAS protocol during the perioperative period; Conventional care groups will undergo standard abdominal hysterectomy without the implementation of ERAS protocol. The groups will be compared with respect to the length of hospital stay, rehospitalizations, and healthcare costs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Active comparator | Other: Enhanced recovery after surge(ERAS) protocolPatients in this group will receive ERAS protocol preoperatively, perioperatively and postoperatively. |
| Control | No intervention | –This group of patients will not receive ERAS care and will undergo a standard laparoscopic hysterectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be scheduled for laparoscopic hysterectomy
Key exclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) class IV
- Development of complications during surgery
- Body mass index > 40 kg/m2
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 surge(ERAS) protocolThe components of ERAS multidisciplinary pathway concerning preoperative, operative, and postoperative period are as follows: 1. Preoperative care: Counseling before hospital admission Fluid, and carbohydrate loading Avoiding prolongation of the fasting period Avoiding bowel preparation or its application only in selective cases Application of antibiotic prophylaxis Application of thromboprophylaxis 2. Perioperative care: Use of short-acting anesthetic agents Application of midthoracic, epidural anesthesia/analgesia Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia Postoperative care: Application of midthoracic, epidural anesthesia/analgesia Prevention of nausea, and vomiting Refraining from salt, and water overload Earlier removal of catheters Initiation of oral intake at an early period Use of nonopioid oral analgesics/NSAIDs Early mobilization | Other | ERAS group |
Primary outcome
Healthcare costs
Time frame: Up to one month
Hospital costs will be obtained from the accounting office of the hospital
1 secondary outcome
Length of stay
Time frame: Up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- 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.
Aysu Akca, MD principal investigator
Kanuni Sultan Suleyman Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced recovery after surge(ERAS) protocol in people with Surgery, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jun 2019. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysu Akca, MD (+902124041500, aysuakca4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare costs (time frame: Up to one month). 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 14 Jun 2019.