Healing of the Wound After Rectovaginal Fistula SurgeryNCT05138965
the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery
An observational study of Healing of the Wound After Rectovaginal Fistula Surgery, run by China Academy of Chinese Medical Sciences at 3 sites in China.
Trial summary
The method of Cotton Padding (mCP) was summarized by combining with many years clinical experience and the traditional ancient books.The mCP could be used in Rectovaginal Fistula (RVF) post operation effectively,in order to improve the wound.The research aim is to observe if the mCP could influence the time of staying… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Healing of the Wound After Rectovaginal Fistula Surgery
- What is being tested?
- the mCP with alginates dressing and only alginates dressing
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 3 sitesChina
- Study dates
- 10 Jan 2022to 15 Mar 2024
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Rectovaginal fistulae are rare and account for less than 5% of all anorectal fistulae[1,2]. The most common cause of RVF is obstetric trauma[2]. Trauma to the rectum, perineum,or vagina may cause RVF.The commonest form of trauma is during or following surgery, although blunt or penetrating trauma to the perineum or use of a foreign body in the vagina or rectum are well-recognized causes.The use of surgical stapling devices during stapled hemorrhoidectomy and stapled transanal rectal resections (STARR) have been implicated. (© Springer Nature Switzerland AG 2021. G.A.Santoro et al. (eds.), Pelvic Floor Disorders, https://doi.org/10.1007/978-3-030-40862-6_79)
Who may be able to join
- rectovaginal fistula because of parturition,stapler,traumatic injury.
Who cannot join
- rectovaginal fistula because of IBD,radiation,cancer.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, 100053
Beijing Mayinglong Changqing Anorectal Hospital
Beijing, 100195
Southern District of Guang'an men Hospital,China Academy of Chinese Medical Sciences
Beijing, 102618
About this study
Official title: Research About the Method of Cotton Padding Promoting the Healing of the Wound After Rectovaginal Fistula Surgery
The method of Cotton Padding (mCP) was summarized by combining with many years clinical experience and the traditional ancient books.The mCP could be used in Rectovaginal Fistula (RVF) post operation effectively,in order to improve the wound.The research aim is to observe if the mCP could influence the time of staying in hospital, healing time after RVF surgery.
Read the detailed description
The method of Cotton Padding (mCP) originating from extensive and profound traditional chinese medicine (TCM) and being one of traditional surgical treatments of chronic wounds,could promote the wound healing after RVF surgery in previous clinical experience.
The research aim is to observe if the mCP could influence the time of staying in hospital, healing time,quality of life,complications after RVF surgery.
Also,investigators will try to explain the mechanism about the mDM improving the wound healing by the chinese architectural theory and the nanomechanical properties.
- Being tested
- the mCP with alginates dressing, only alginates dressing
- Keywords
- Rectovaginal Fistula, Healing, Cotton Padding
- Medical subject headings
- Rectovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the mCP with alginates dressingProcedure or surgery
Also called the method of cotton padding with alginates dressing
The method is to use gauzes folded onto the RVF wound surface to compact the deep wound so as to solid and durable,when the gauzes surface will be covered by alginates dressing.
only alginates dressingProcedure or surgery
Also called only alginates dressing without the mCP
Only alginates dressing will be placed above the RVF wound without any pressure.
| Study group | Role | What they receive |
|---|---|---|
| using the mCP | When the secretion reducing or the wound suture being removed, two pieces of 5cm×7cm-12p sterile gauzes will be crimped by the long side as the center of the reel,and be made as cylindrical gauze rolls with about D=1.5cm. After cleaning the wound, the cylindrical gauze rolls with its surface covered by alginates dressing will be placed above the vaginal wound with the help of endoscope.Itself tension of the rolls pressuring on the wound and the deep tissue can promote the wound healing. The rolls will be placed on about 5-6 hours every time, 2 times a day, for 7 days.Then observing the wound, if necessary, the method will be executed for another 7 days. Receives: Procedure: the mCP with alginates dressing | |
| no using the mCP | When the secretion reducing or the wound suture bing removed, only alginates dressing will be placed above the vaginal wound with the help of endoscope, without any pressure, being placed about 5-6 hours every time, 2 times a day, for 7 days. Receives: Procedure: only alginates dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time of healing
the time of healing
Measured: 28days-40days
Secondary outcomes (2)
the time of staying hospital
the time of staying hospital
Measured: 7days-21days
occurrence rate of complications
occurrence rate of complications,including recurrence,blooding,wound dehiscence.
Measured: 1day-90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start10 Jan 2022
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing of the Wound After Rectovaginal Fistula 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FENG Li-peng, China Academy of Chinese Medical Sciences
- Investigators
- LI guodong, Study director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138965
- Sponsor's protocol ID
- 2021-11-15
- Status last verified
- Mar 2024
- First submitted
- 15 Nov 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline the results reported in the article after identification, excluding the private information of participants.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research About the Method of Cotton Padding Promoting the Healing of the Wound After Rectovaginal Fistula Surgery
- ClinicalTrials.gov ID
- NCT05138965
- Acronym / sponsor ID
- 2021-11-15
- Keywords
- Rectovaginal Fistula, Healing, Cotton Padding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 1 Dec 2021 (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.
The method of Cotton Padding (mCP) was summarized by combining with many years clinical experience and the traditional ancient books.The mCP could be used in Rectovaginal Fistula (RVF) post operation effectively,in order to improve the wound.The research aim is to observe if the mCP could influence the time of staying in hospital, healing time after RVF surgery.
Detailed description
The method of Cotton Padding (mCP) originating from extensive and profound traditional chinese medicine (TCM) and being one of traditional surgical treatments of chronic wounds,could promote the wound healing after RVF surgery in previous clinical experience.
The research aim is to observe if the mCP could influence the time of staying in hospital, healing time,quality of life,complications after RVF surgery.
Also,investigators will try to explain the mechanism about the mDM improving the wound healing by the chinese architectural theory and the nanomechanical properties.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| using the mCP | – | Procedure: the mCP with alginates dressingWhen the secretion reducing or the wound suture being removed, two pieces of 5cm×7cm-12p sterile gauzes will be crimped by the long side as the center of the reel,and be made as cylindrical gauze rolls with about D=1.5cm. After cleaning the wound, the cylindrical gauze rolls with its surface covered by alginates dressing will be placed above the vaginal wound with the help of endoscope.Itself tension of the rolls pressuring on the wound and the deep tissue can promote the wound healing. The rolls will be placed on about 5-6 hours every time, 2 times a day, for 7 days.Then observing the wound, if necessary, the method will be executed for another 7 days. |
| no using the mCP | – | Procedure: only alginates dressingWhen the secretion reducing or the wound suture bing removed, only alginates dressing will be placed above the vaginal wound with the help of endoscope, without any pressure, being placed about 5-6 hours every time, 2 times a day, for 7 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Rectovaginal fistulae are rare and account for less than 5% of all anorectal fistulae[1,2]. The most common cause of RVF is obstetric trauma[2]. Trauma to the rectum, perineum,or vagina may cause RVF.The commonest form of trauma is during or following surgery, although blunt or penetrating trauma to the perineum or use of a foreign body in the vagina or rectum are well-recognized causes.The use of surgical stapling devices during stapled hemorrhoidectomy and stapled transanal rectal resections (STARR) have been implicated. (© Springer Nature Switzerland AG 2021. G.A.Santoro et al. (eds.), Pelvic Floor Disorders, https://doi.org/10.1007/978-3-030-40862-6_79)
Key inclusion criteria (1 listed)
- rectovaginal fistula because of parturition,stapler,traumatic injury.
Key exclusion criteria (1 listed)
- rectovaginal fistula because of IBD,radiation,cancer.
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 |
|---|---|---|
| the mCP with alginates dressingAlso: the method of cotton padding with alginates dressingThe method is to use gauzes folded onto the RVF wound surface to compact the deep wound so as to solid and durable,when the gauzes surface will be covered by alginates dressing. | Procedure or surgery | using the mCP |
| only alginates dressingAlso: only alginates dressing without the mCPOnly alginates dressing will be placed above the RVF wound without any pressure. | Procedure or surgery | no using the mCP |
Primary outcome
the time of healing
Time frame: 28days-40days
the time of healing
2 secondary outcomes
the time of staying hospital
Time frame: 7days-21days
occurrence rate of complications
Time frame: 1day-90days
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 18 Mar 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported in the article after identification, excluding the private information of participants.
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.
LI guodong study director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healing of the Wound After Rectovaginal Fistula Surgery, run by China Academy of Chinese Medical Sciences at 3 sites in China.
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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
the time of healing (time frame: 28days-40days). 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 18 Mar 2024.