Febrile MorbidityNCT03537313
Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy
A study testing Vagina douching and Vagina painting in people with Febrile Morbidity, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile morbidity after total abdominal hysterectomy Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Febrile Morbidity
- What is being tested?
- Vagina douching and Vagina painting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteThailand
- Study dates
- 15 Aug 2018to 30 Sep 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who undergoing total abdominal hysterectomy
- Woman who agrees to participate in this study
Who cannot join
- Women with history of sea-food or iodine allergy
- Women who undergo emergency TAH
- Women who have intestinal resection in this operation
- Women who have active pelvic inflammatory disease before operation
- Women who have fever before operation
- Women who received antibiotic within 1 weeks before operation
- Women who be immunocompromised host
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy: A Factorial 2-by-2 Open-labeled Randomized Controlled Trial
Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile morbidity after total abdominal hysterectomy
Read the detailed description
Total abdominal hysterectomy (TAH) is the most common gynecologic operation worldwide. The two most common complications after TAH are febrile and infectious morbidities, incidence varying between 5 and 50 percent. After performing TAH, vaginal canal must be breached and closed to be blind-pouch stump. Routing vaginal douching at the night before and on the morning of the surgical date, and intra-operative painting are routinely practiced. However, no good quality of evidence base supports the effectiveness of vaginal douching and painting in preventing febrile and infectious morbidities after TAH.
- Conditions
- Febrile Morbidity
- Being tested
- Vagina douching, Vagina painting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagina douchingProcedure or surgery
Vaginal douches with 1000 ml of 1% povidone-iodine solution on the night before surgery and again on the morning of surgery
Vagina paintingProcedure or surgery
Vaginal painting of vagina stump after hysterectomy with 10% povidone-iodine solution 30 ml
| Study group | Role | What they receive |
|---|---|---|
| Control-douching group | No intervention | No preoperative vagina douching |
| Control-painting group | No intervention | No intra-operative vagina painting |
| Vaginal douching group | Experimental | Preoperative vaginal douches with povidone-iodine solution Receives: Procedure: Vagina douching |
| Vaginal painting group | Experimental | Intra-operative vaginal painting with povidone-iodine solution Receives: Procedure: Vagina painting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Febrile morbidity
Defined as the presence of an oral temperature > 38 o C (100.4 o F) on two occasions at least 4 hours apart in the post-operative period excluding the first 24 hours
Measured: Day 1-7 after surgery
Secondary outcomes (2)
Vaginal cuff infection
Defined as redness, tenderness, infiltration or abscess at vaginal cuff
Measured: 2 weeks after surgery
Other infectious morbidities
Defined by the presence of a urinary tract infection, abdominal wound infection, or pneumonitis; urinary tract infection defined as symptomatic infection with a mid-steam urine specimen showed bacterial growth > 105 bacteria/ml of urine; surgical wound infection defined as redness, tenderness, infiltration or abscess; pneumonitis defined as fever, physical and radiological findings of consolidation
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start15 Aug 2018
- Primary completion15 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile MorbidityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Factorial 2-by-2 open labeled randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537313
- Sponsor's protocol ID
- RJVAG001
- Status last verified
- May 2018
- First submitted
- 11 May 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Douching and Painting in Women Who Underwent Total Abdominal Hysterectomy: A Factorial 2-by-2 Open-labeled Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03537313
- Acronym / sponsor ID
- RJVAG001
- Conditions
- Febrile Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 25 May 2018 (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.
Comparison of the effectiveness of povidone-iodine douching and painting for reducing febrile morbidity after total abdominal hysterectomy
Detailed description
Total abdominal hysterectomy (TAH) is the most common gynecologic operation worldwide. The two most common complications after TAH are febrile and infectious morbidities, incidence varying between 5 and 50 percent. After performing TAH, vaginal canal must be breached and closed to be blind-pouch stump. Routing vaginal douching at the night before and on the morning of the surgical date, and intra-operative painting are routinely practiced. However, no good quality of evidence base supports the effectiveness of vaginal douching and painting in preventing febrile and infectious morbidities after TAH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Factorial 2-by-2 open labeled randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control-douching group | No intervention | –No preoperative vagina douching |
| Control-painting group | No intervention | –No intra-operative vagina painting |
| Vaginal douching group | Experimental | Procedure: Vagina douchingPreoperative vaginal douches with povidone-iodine solution |
| Vaginal painting group | Experimental | Procedure: Vagina paintingIntra-operative vaginal painting with povidone-iodine solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women who undergoing total abdominal hysterectomy
- Woman who agrees to participate in this study
Key exclusion criteria (7 listed)
- Women with history of sea-food or iodine allergy
- Women who undergo emergency TAH
- Women who have intestinal resection in this operation
- Women who have active pelvic inflammatory disease before operation
- Women who have fever before operation
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 |
|---|---|---|
| Vagina douchingVaginal douches with 1000 ml of 1% povidone-iodine solution on the night before surgery and again on the morning of surgery | Procedure or surgery | Vaginal douching group |
| Vagina paintingVaginal painting of vagina stump after hysterectomy with 10% povidone-iodine solution 30 ml | Procedure or surgery | Vaginal painting group |
Primary outcome
Febrile morbidity
Time frame: Day 1-7 after surgery
Defined as the presence of an oral temperature > 38 o C (100.4 o F) on two occasions at least 4 hours apart in the post-operative period excluding the first 24 hours
2 secondary outcomes
Vaginal cuff infection
Time frame: 2 weeks after surgery
Other infectious morbidities
Time frame: 2 weeks after surgery
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 22 Oct 2020.
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?
A study testing Vagina douching and Vagina painting in people with Febrile Morbidity, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 2 inclusion and 7 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 22 Oct 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 Thailand. 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?
Febrile morbidity (time frame: Day 1-7 after surgery). 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 22 Oct 2020.