the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery

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.

Study Overview

• Status: Completed
• Conditions: Healing of the Wound After Rectovaginal Fistula Surgery
• Intervention / Treatment: Procedure: the mCP with alginates dressing; Procedure: only alginates dressing

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

• Study Contact: Name: FENG lipeng; Phone Number: +86 13488814577; Email: venus59514@sina.com
• Study Contact Backup: Name: LI guodong; Phone Number: +86 (010)88001025; Email: angellea1028@qq.com

Study Locations

• China
  • Beijing, China, 100053
    • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  • Beijing, China, 100195
    • Beijing Mayinglong Changqing Anorectal Hospital
  • Beijing, China, 102618
    • Southern District of Guang'an men Hospital,China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• 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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

• rectovaginal fistula because of IBD,radiation,cancer.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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.; Other Names: the method of cotton padding 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.	Procedure: only alginates dressing; Only alginates dressing will be placed above the RVF wound without any pressure.; Other Names: only alginates dressing without the mCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time of healing	the time of healing	28days-40days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time of staying hospital	the time of staying hospital	7days-21days
occurrence rate of complications	occurrence rate of complications,including recurrence,blooding,wound dehiscence.	1day-90days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90days-180days

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Investigators: Study Director: LI guodong, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Healing; Rectovaginal Fistula; Cotton Padding
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Vaginal Diseases; Intestinal Fistula; Digestive System Fistula; Rectal Fistula; Vaginal Fistula; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Fistula; Rectovaginal Fistula
• Other Study ID Numbers: 2021-11-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underline the results reported in the article after identification, excluding the private information of participants.
• IPD Sharing Time Frame: Becoming available after publication and ending 12 months following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No