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.
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.
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:
- Rectovaginal fistula caused by obstetric problems
- Female >20 years
Exclusion criteria:
- other causes of rectovaginal fistula as Crohn's disease or malignant fistula
- 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.
- Conditions
- Recto Vaginal Fistula
- 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 group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | RVF with Martius flap Receives: Procedure: rectovaginal fistula repair with Martius flap |
| group 2 | Experimental | RVF 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.
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.
- First posted13 Feb 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recto Vaginal FistulaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer Alsaied Alnaimy, Zagazig University
- Investigators
- tamer A. alnaimy, MD, Principal investigator, Zagazig University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04267757
- Acronym / sponsor ID
- zagazig 2
- Conditions
- Recto Vaginal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Rectovaginal fistula caused by obstetric problems
- Female >20 years
Exclusion criteria:
- other causes of rectovaginal fistula as Crohn's disease or malignant fistula
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Procedure: rectovaginal fistula repair with Martius flapRVF with Martius flap |
| group 2 | Experimental | Procedure: rectovaginal fistula repair with Martius flapRVF without Martius flap |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1- Rectovaginal fistula caused by obstetric problems 2- Female >20 years
Key exclusion criteria (2 listed)
- other causes of rectovaginal fistula as Crohn's disease or malignant fistula
- complex and recurrent fistula -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rectovaginal fistula repair with Martius flaprectovaginal fistula repair with Martius flap | Procedure or surgery | group 1, group 2 |
Primary outcome
rectovaginal fistula repair with or without Martius flap
Time frame: 1 year
detect recurrence in rectovaginal fistula repair with or without Martius flap
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tamer A. alnaimy, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
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.