Clinical trial NCT05138965: the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery
Official title: Research About the Method of Cotton Padding Promoting the Healing of the Wound After Rectovaginal Fistula Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healing of the Wound After Rectovaginal Fistula Surgery
Keywords: Rectovaginal Fistula
Healing
Cotton Padding
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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)

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* rectovaginal fistula because of parturition,stapler,traumatic injury.

Exclusion Criteria:

* rectovaginal fistula because of IBD,radiation,cancer.

Primary outcomes:
measure: the time of healing
timeFrame: 28days-40days
Secondary outcomes:
measure: the time of staying hospital
timeFrame: 7days-21days
measure: occurrence rate of complications
timeFrame: 1day-90days
Other outcomes:
measure: the quality of life post-operation
timeFrame: 90days-180days
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
city: Beijing
country: China
facility: Beijing Mayinglong Changqing Anorectal Hospital
city: Beijing
country: China
facility: Southern District of Guang'an men Hospital,China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: LI guodong
role: STUDY_DIRECTOR
References: