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Recto Vaginal FistulaNCT04267757

Transperineal Repair of Primary Obstetric Rectovaginal Fistulas

A study testing rectovaginal fistula repair with Martius flap in people with Recto Vaginal Fistula, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction: A rectovaginal fistula (RVF) is an epithelium-lined abnormal tract between the rectum and the vagina and is often a challenging problem for both the patients and to the surgeons. In literature, there is still debate regarding the best treatment options for rectovaginal fistulas. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Recto Vaginal Fistula
What is being tested?
rectovaginal fistula repair with Martius flap
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteEgypt
Study dates
1 Jan 2018to 1 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 1- Rectovaginal fistula caused by obstetric problems 2- Female >20 years

Who cannot join

  • other causes of rectovaginal fistula as Crohn's disease or malignant fistula
  • complex and recurrent fistula -

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tamer Alsaied Alnaimy

    Zagazig, Sharqia Province, 055

Other trials in Egypt

About this study

Official title: Transperineal Repair of Primary Obstetric Rectovaginal Fistulas With Fecal Incontinence Using Fistulectomy, Sphincteroplasty and With or Without Bulbocavernosus Muscle Flap:Surgical Pitfalls and Prevention of Recurrence

Introduction: A rectovaginal fistula (RVF) is an epithelium-lined abnormal tract between the rectum and the vagina and is often a challenging problem for both the patients and to the surgeons. In literature, there is still debate regarding the best treatment options for rectovaginal fistulas.

Aim: To assess the results of the treatment of rectovaginal fistulas with incontinence and impaired anal tonus using fistulectomy, sphincteroplasty with or without bulbocavernosus muscle (Martius) flap.

Materials and Methods: A total of 22 consecutive patients with simple RVFs were included and assigned to transperineal repair. The patients were divided into two groups , group1: with Martius flap; group2: without Martius flap .Postoperatively, patients were followed up for one year at the outpatient clinic or through telephone interviews with specific questionnaires to collect information on the status of fecal control, flatus, or fecal leakage from the vagina.

Read the detailed description

Introduction:

Rectovaginal fistulas represent an often devastating condition in patients and a challenge for surgeons because of their irritating and embarrassing symptoms and high failure rate after repair.Patients with rectovaginal fistulas typically present with complaints of passage of flatus or feces from the vagina with painful skin excoriation.

(1) The most common etiological cause of rectovaginal fistulas is obstetrical trauma. When obstructed labor is unrelieved, the presenting fetal part is impacted against the soft tissues of the pelvis leading to ischemic vascular injury and subsequent tissue necrosis and fistula formation. Other predisposing factors include forceps delivery, midline episiotomy, and third or fourth-degree perineal lacerations.( 2).

Evaluation of a patient with rectovaginal fistula includes a detailed history, examination of the rectum, vagina, and perineal body. The perineal body is often thin or nearly nonexistent in patients with sphincter injuries secondary to obstetrical trauma. Endoanal ultrasonography and pelvic Magnetic Resonance Imaging (MRI) to confirm sphincter injury and may provide valuable information before a planned repair. MR is the modality of choice for disease staging (sensitivity 91%) (3).

( Sagittal T2 MR imaging shows communication between the rectum tumor and the vagina) The experience of the surgeon and the previous attempts at repair are also important factors of the success rate of the operations [4)

There are various operative procedures, such as the advancement flap, sphincteroplasty and fistulectomy, coloanal anastomosis,and gracilis muscle repair to manage rectovaginal fistulas [5].

The choice of the operative technique greatly depends on the status of the fistula and the etiological rationale behind this medical complication [6.].

In this study, we have compared the outcomes of the fistulectomy and sphincteroplasty procedures with or without concomitant bulbocavernosus flap. All patients were incontinent and felt to have impaired anal tonus.

Patients and method:

Study design:

This prospective study involved 22 patients diagnosed with simple rectovaginal fistula from January 2018 to January 2019 at the General surgical department, faculty of medicine Zagazig University, Egypt. This study was approved by the institutional ethics board of our hospital. All patients who participated in the study provided informed consent.

rectovaginal examination, endoanal ultrasonography, and pelvic MRI findings were collected to assess the extension of the fistula. Colonoscopy was performed in selected patients with severe bowel symptoms such as bloody diarrhea to exclude inflammatory bowel disease. Decisions regarding operations were made cautiously and involved the whole medical team. All cases underwent fistulectomy, sphincteroplasty and with or without bulbocavernosus flap technique.All patients were evaluated for incontinence using Wexner Incontinence Score (WIS) [7) Method of randomization: simple randomization with a balance.

Patient selection:

Inclusion criteria:

  1. Rectovaginal fistula caused by obstetric problems
  2. Female >20 years

Exclusion criteria:

  1. other causes of rectovaginal fistula as Crohn's disease or malignant fistula
  2. complex and recurrent fistula

Three patients did not undergo surgery. One because of patient's choice, one because of minimal symptoms and one because fistula healed after medical therapy.

Methods:

Patients were given a mechanical bowel preparation the day before surgery and an enema on the morning of the operation. The patient was placed in the lithotomy position under spinal anesthesia. Antibiotics in the form of third generation cephalosporin and 500 mg of Metronidazole were given.

Sub mucosal lidocain 5% in adrenalized saline at a ratio of 1: 100 000 was injected around the fistula. Surgical excision of the fistula using scalpel was performed. Biopsies of rectal mucosa and the fistula margin were also obtained for pathological evaluation to exclude an underlying Crohn's disease or malignancy. A transverse perineal incision was done. Dissection of the internal sphincter fibers away from the external sphincter fibers was performed, allowing a tension free rectal closure at the fistulous site (Dissection of internal sphincter fi bers from external sphincter fi ber s.). Closure of the fistulous opening at the rectal side was done using Vicryl 3/0 sutures. This was followed by suturing of the rectovaginal septum to the internal sphincteric fibers using Vicryl 3/0 sutures (Suturing of internal sphincter fi bers to the rectovaginal septu m.). The bulbocavernosus muscle flap was harvested from the left side in all patients at its anterior part, preserving the posteroexternal vascular pedicle (Posterior muscle repair), through the same incision, and sutured across the rectum to its counterpart on the other side (Vaginal advancement fl a p.\& Fig. 1 a The fistulae are indicated by the two forceps passing through them; b The finger demonstrates the large recto-vaginal orifice) using 2/0 Vicryl sutures. The vaginal flap was advanced at the fistula site and sutured to the perineal skin using Vicryl 3/0 sutures (Preparation of the bulbocavernosus fl a p.\& Fig. 3 a, b After a right labial incision, the bulbocavernous muscle and the surrounding fibroadipose tissue were carefully mobilized, avoiding possible damage of the postero-external vascular pedicle\& Fig. 4 A subcutaneous tunnel connecting the two incisions was created after transecting superior to the bulbocavernous muscle\& Fig. 5 The final set-up with the interrupted absorbable sutures over the vaginal closure after sectioning of the longitudinal vaginal septum. The bulbocavernous muscle is clearly visible after the lay open of the perineovaginal tract).

No suction drain was used. No covering stoma was done. Postoperatively, Soft, stool was provided in the postoperative period at least for two weeks with the help of clear liquid diet, plenty fluid intake, and the use of stool softeners. Oral broad-spectrum antibiotic therapy was given for 3-5 days postoperatively. Sexual activity or any physical activities more strenuous than a slow walk were avoided by the patients for three weeks after the surgery. Follow up period up to one year.

Being tested
rectovaginal fistula repair with Martius flap
Medical subject headings
Rectovaginal Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rectovaginal fistula repair with Martius flapProcedure or surgery

    rectovaginal fistula repair with Martius flap

Study groups in NCT04267757
Study groupRoleWhat they receive
group 1ExperimentalRVF with Martius flap
Receives: Procedure: rectovaginal fistula repair with Martius flap
group 2ExperimentalRVF without Martius flap
Receives: Procedure: rectovaginal fistula repair with Martius flap

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rectovaginal fistula repair with or without Martius flap

    detect recurrence in rectovaginal fistula repair with or without Martius flap

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start1 Jan 2018
  3. Primary completion1 Jan 2019
  4. Study completion1 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04267757
Sponsor's protocol ID
zagazig 2
Status last verified
Feb 2020
First submitted
9 Feb 2020
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing rectovaginal fistula repair with Martius flap in people with Recto Vaginal Fistula, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rectovaginal fistula repair with or without Martius flap (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.

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