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NCT Number: NCT05138965

the Method of Cotton Padding Promoting the 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.

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Key information

Conditions

Healing of the Wound After Rectovaginal Fistula Surgery Digestive System Diseases Digestive System Fistula Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula Rectovaginal Fistula Urogenital Diseases Vaginal Diseases Vaginal Fistula

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Beijing Mayinglong Changqing Anorectal Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • rectovaginal fistula because of IBD,radiation,cancer.

Treatment and study plan

the mCP with alginates dressing

Procedure

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.

Other names: the method of cotton padding with alginates dressing

only alginates dressing

Procedure

Only alginates dressing will be placed above the RVF wound without any pressure.

Other names: only alginates dressing without the mCP

Primary outcomes

  1. the time of healing

    Time frame: 28days-40days

    the time of healing

Secondary outcomes

  1. the time of staying hospital

    Time frame: 7days-21days

    the time of staying hospital

  2. occurrence rate of complications

    Time frame: 1day-90days

    occurrence rate of complications,including recurrence,blooding,wound dehiscence.

Other outcomes

  1. the quality of life post-operation

    Time frame: 90days-180days

    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.

Sponsors and collaborators

Lead sponsor

China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Research About the Method of Cotton Padding Promoting the Healing of the Wound After Rectovaginal Fistula Surgery

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 1, 2021
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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