Urinary IncontinenceNCT04008654
Evaluation of the Benefits of Enhanced Recovery After Surgery (ERAS) Protocol in Pelvic Prolapse
A study testing ERAS Protocol and Conventional care in people with Urinary Incontinence and Pelvic Organ Prolapse, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
ERAS protocols have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay. This study aims to investigate the impact of ERAS protocol on time to mobilization and length of hospital stay in patients undergoing surgery for urinary incontinence and pelvic… Read more about this study
- Who is it for?
- Ages 35 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence, Pelvic Organ Prolapse
- What is being tested?
- ERAS Protocol and Conventional care
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2019to 20 Feb 2020
- 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 35 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be scheduled for surgery because of urinary incontinence or pelvic organ prolapse
Who cannot join
- Insulin dependent diabetes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Please Enter the State Or Province, 34005
About this study
Official title: Implementation of ERAS Protocol in Patients Undergoing Surgery for Urinary Incontinence or Pelvic Organ Prolapse
ERAS protocols have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay. This study aims to investigate the impact of ERAS protocol on time to mobilization and length of hospital stay in patients undergoing surgery for urinary incontinence and pelvic prolapse.
Read the detailed description
ERAS protocols containing several preoperative, intraoperative and postoperative measures have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay in patients undergoing surgery. However, data concerning the role of ERAS protocols in urogynecological surgery is limited. The present study, therefore, aimed to address the role of ERAS protocols in patients undergoing surgery for urinary incontinence and pelvic prolapse.
- Conditions
- Urinary Incontinence, Pelvic Organ Prolapse
- Being tested
- ERAS Protocol, Conventional care
- Medical subject headings
- Urinary Incontinence, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS ProtocolBehavioural
Preoperative measures:
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 Avoiding premedication
Intraoperative measures:
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 (heating the body, and use of warmed up intravenous fluids)
Postoperative:
Application of midthoracic, epidural anesthesia/analgesia Refraining from use of nasogastric tube 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 Adherence to the protocol, and auditing results
Conventional careBehavioural
This group of patients will not receive the specific ERAS protocol but will receive conventional care.
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Active comparator | This groups will receive ERAS protocol Receives: Behavioral: ERAS Protocol |
| Conventional care | Placebo comparator | This group will not receive the ERAS protocol. Receives: Behavioral: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulation
Time to ambulation
Measured: Up to 1 week
Hospital stay
Length of hospital stay
Measured: Up to 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start5 Jul 2019
- Primary completion15 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huseyin Kiyak, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Huseyin Kiyak, MD, Principal investigator, Kanuni Sultan Suleyman Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008654
- Sponsor's protocol ID
- Huseyin2
- Status last verified
- Feb 2020
- First submitted
- 30 Jun 2019
- Last updated
- 20 Feb 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 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of ERAS Protocol in Patients Undergoing Surgery for Urinary Incontinence or Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT04008654
- Acronym / sponsor ID
- Huseyin2
- Conditions
- Urinary Incontinence, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 5 Jul 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 protocols have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay. This study aims to investigate the impact of ERAS protocol on time to mobilization and length of hospital stay in patients undergoing surgery for urinary incontinence and pelvic prolapse.
Detailed description
ERAS protocols containing several preoperative, intraoperative and postoperative measures have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay in patients undergoing surgery. However, data concerning the role of ERAS protocols in urogynecological surgery is limited. The present study, therefore, aimed to address the role of ERAS protocols in patients undergoing surgery for urinary incontinence and pelvic prolapse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Active comparator | Behavioral: ERAS ProtocolThis groups will receive ERAS protocol |
| Conventional care | Placebo comparator | Behavioral: Conventional careThis group will not receive the ERAS protocol. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be scheduled for surgery because of urinary incontinence or pelvic organ prolapse
Key exclusion criteria (1 listed)
- Insulin dependent diabetes
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 |
|---|---|---|
| ERAS ProtocolPreoperative measures: 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 Avoiding premedication Intraoperative measures: 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 (heating the body, and use of warmed up intravenous fluids) Postoperative: Application of midthoracic, epidural anesthesia/analgesia Refraining from use of nasogastric tube 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 Adherence to the protocol, and auditing results | Behavioural | ERAS group |
| Conventional careThis group of patients will not receive the specific ERAS protocol but will receive conventional care. | Behavioural | Conventional care |
Primary outcome
Ambulation
Time frame: Up to 1 week
Time to ambulation
Hospital stay
Time frame: Up to 1month
Length of hospital stay
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 20 Feb 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.
Huseyin Kiyak, 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 ERAS Protocol and Conventional care in people with Urinary Incontinence and Pelvic Organ Prolapse, 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 1 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 20 Feb 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 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. Some participants in this study may receive a placebo. 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?
Ambulation (time frame: Up to 1 week). The study lists 2 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 20 Feb 2020.