the Method of Cotton Padding Promoting the Rectovaginal Fistula Surgery

NCT05138965 | Completed

• 1 other identifier: 2021-11-15
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Healing of the Wound After Rectovaginal Fistula Surgery

Keywords

Rectovaginal Fistula; Healing; Cotton Padding

Outcome Measures

Primary Outcomes (1)

• the time of healing

  the time of healing

  28days-40days

Secondary Outcomes (2)

• the time of staying hospital

  7days-21days

• occurrence rate of complications

  1day-90days

Other Outcomes (1)

• the quality of life post-operation

  90days-180days

Study Arms (2)

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

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

Interventions

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.

Also known as: the method of cotton padding with alginates dressing

using the mCP

only alginates dressing PROCEDURE

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

Also known as: only alginates dressing without the mCP

no using the mCP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

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

You may not qualify if:

• rectovaginal fistula because of IBD,radiation,cancer.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

Study Sites (3)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, 100053, China

Location

Beijing Mayinglong Changqing Anorectal Hospital

Beijing, 100195, China

Location

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

Beijing, 102618, China

Location

MeSH Terms

Conditions

Rectovaginal Fistula

Condition Hierarchy (Ancestors)

Rectal Fistula; Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Vaginal Fistula; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• LI guodong

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 1, 2021
• Study Start: January 10, 2022
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

CN (3)