An observational study in Healing of the Wound After Rectovaginal Fistula Surgery, sponsored by China Academy of Chinese Medical Sciences. Completed at 3 sites in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by China Academy of Chinese Medical Sciences · Observational
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.
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.
China Academy of Chinese Medical Sciences is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
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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)
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Exclusion Criteria:
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.
Procedure: the mCP with alginates dressing
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.
Procedure: only 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.
Also known as: the method of cotton padding with alginates dressing
Only alginates dressing will be placed above the RVF wound without any pressure.
Also known as: only alginates dressing without the mCP
the time of healing
the time of healing
Time frame: 28days-40days
the time of staying hospital
the time of staying hospital
Time frame: 7days-21days
occurrence rate of complications
occurrence rate of complications,including recurrence,blooding,wound dehiscence.
Time frame: 1day-90days
the quality of life post-operation
using the Wexner continence score (WCS) or the Vaizey score (VS) to assess the fecal incontinence,and using the Female sexual function index (FSFI) to assess the sex life,and aslo using the Clavien-Dindo classification(CDC) to assess other situation postoperatively.
Time frame: 90days-180days
Plan to share: Yes — Individual participant data that underline the results reported in the article after identification, excluding the private information of participants.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Becoming available after publication and ending 12 months following article publication.
Access criteria: Proposals should be emailed to venus59514@sina.com.To gain access, data requestors will need to sign a data access agreement and offer payment.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Rectovaginal Fistula
China Academy of Chinese Medical Sciences