the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery

NCT ID: NCT05138965

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-10

Study Completion Date

2024-03-15

Brief Summary

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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

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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.

Conditions

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Healing of the Wound After Rectovaginal Fistula Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

the mCP with alginates dressing

Intervention Type 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.

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.

only alginates dressing

Intervention Type PROCEDURE

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

Interventions

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the mCP 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.

Intervention Type PROCEDURE

only alginates dressing

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

Intervention Type PROCEDURE

Other Intervention Names

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the method of cotton padding with alginates dressing only alginates dressing without the mCP

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* rectovaginal fistula because of IBD,radiation,cancer.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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FENG Li-peng

Attending Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LI guodong

Role: STUDY_DIRECTOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Locations

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, , China

Site Status

Beijing Mayinglong Changqing Anorectal Hospital

Beijing, , China

Site Status

Southern District of Guang'an men Hospital,China Academy of Chinese Medical Sciences

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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2021-11-15

Identifier Type: -

Identifier Source: org_study_id

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