RectoceleNCT06604702
Fat Injection for Rectocele Treatment: A Novel Approach
A study testing Autologous Fat Injection for Rectocele in people with Rectocele and Pelvic Organ Prolapse, run by Cairo University.
Trial summary
This clinical trial aims to evaluate the effectiveness of autologous fat grafting as a novel treatment for rectocele, a condition characterized by the herniation of rectal tissue into the posterior vaginal wall. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Rectocele, Pelvic Organ Prolapse, Obstructive Defecation Syndrome
- What is being tested?
- Autologous Fat Injection for Rectocele
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2024to 20 Oct 2025
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged between 18 and 60 years.
- Diagnosis of rectocele confirmed by defecography, with a rectocele size of 2 cm (mild) to 4 cm (moderate).
- Presenting with symptoms of obstructive defecation syndrome, including constipation, incomplete defecation, and/or vaginal bulge.
- Able to provide written informed consent to participate in the study.
Who cannot join
- Patients who have previously undergone surgical repair of rectocele.
- Presence of thrombosed hemorrhoids.
- History of sclerotherapy injection for rectocele.
- Diagnosis of anal stenosis.
- History of coagulopathy or current use of anticoagulant or antiplatelet medications.
- Refusal or inability to provide informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Fat Injection for Treatment of Rectocele a Novel Technique for Treatment of Tectocele
This clinical trial aims to evaluate the effectiveness of autologous fat grafting as a novel treatment for rectocele, a condition characterized by the herniation of rectal tissue into the posterior vaginal wall. Women aged 18 to 60 years with mild to moderate rectocele, presenting with symptoms such as obstructive defecation or vaginal bulge, will undergo submucosal fat injections. The study will assess the procedure\'s ability to alleviate symptoms and reduce prolapse recurrence. This prospective, single-arm trial will be conducted at Cairo University Hospitals.
- Being tested
- Autologous Fat Injection for Rectocele
- Keywords
- Rectocele, Pelvic Floor Dysfunction, Fat Grafting, Autologous Fat Injection, Obstructive Defecation, Pelvic Organ Prolapse, Vaginal Bulge
- Medical subject headings
- Rectocele, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fat Injection for RectoceleProcedure or surgery
In this procedure, autologous fat is harvested from the patient\'s lower abdomen using a multiport cannula. The fat is then processed via centrifugation to separate the viable fat cells, which are emulsified into nanofat. This nanofat is injected into the submucosal layer of the rectocele through the posterior vaginal wall, using an anoscope for guidance. The procedure is intended to reinforce the rectovaginal fascia, alleviate rectocele symptoms such as obstructive defecation and vaginal bulge, and reduce prolapse recurrence.
| Study group | Role | What they receive |
|---|---|---|
| Fat Injection for Rectocele | Experimental | Participants in this arm will undergo autologous fat injection as a novel treatment for rectocele. Fat grafts will be harvested from the patient's abdomen, processed to purify the fat, and injected into the submucosal layer of the rectocele through the posterior vaginal wall. This procedure aims to reduce the size of the rectocele, alleviate symptoms like vaginal bulge and obstructive defecation, and prevent recurrence. Receives: Procedure: Autologous Fat Injection for Rectocele |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Rectocele Size
The outcome will assess the reduction in rectocele size, measured by clinical examination and defecography. Improvement in rectocele grade will be quantified using a standardized rectocele grading scale.
Rectocele Grading Scale:
Grade 0: No prolapse of the rectal wall into the vaginal canal. Grade 1: Mild prolapse, where the rectal wall descends slightly into the vaginal canal, typically during straining, but does not reach the vaginal introitus.
Grade 2: Moderate prolapse, where the rectal wall descends to the level of the vaginal introitus during straining or bowel movements.
Grade 3: Severe prolapse, where the rectal wall protrudes beyond the vaginal introitus, visible externally, especially during straining.
This scale would be used to assess the reduction in rectocele size over time as part of your primary outcome. You can adjust the wording in the outcome measure description to reflect this specific scale.
Measured: 6 months post-procedure
Symptom Relief
In this we will evaluate the patient's relief from rectocele-associated symptoms, including vaginal bulge and obstructive defecation. This will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire. The PFDI-20 measures the severity of pelvic floor symptoms on a scale of 0 to 4 for each item, with higher scores indicating greater distress.
Unit of Measure: PFDI-20 Symptom Score (0-100, where 0 represents no distress and 100 represents maximum distress)
Measured: 6 months post-procedure
Secondary outcomes (2)
Rate of Recurrence of Rectocele
This outcome will track the recurrence of rectocele after the autologous fat injection procedure. Recurrence will be defined as the reappearance of rectocele symptoms or the identification of prolapse on clinical examination or defecography.
Measured: 6 months post-procedure
Postoperative Pain
This outcome will assess postoperative pain and discomfort using a standardized pain scale (e.g., Visual Analog Scale) at regular intervals. It will evaluate both the intensity and duration of pain following the fat injection procedure.
Visual Analog Scale (VAS) for Pain:
The Visual Analog Scale (VAS) is a tool used to measure pain intensity. It consists of a horizontal line, typically 10 cm in length, with the following markers:
0 cm: No Pain 5 cm: Moderate Pain 10 cm: Worst Pain Imaginable Participants will be asked to mark a point on the line that best represents their level of pain. The distance from the \"No Pain\" end to the mark is measured in centimeters to give a quantitative assessment of pain intensity.
Interpretation:
0 cm: No Pain 1-3 cm: Mild Pain 4-6 cm: Moderate Pain 7-9 cm: Severe Pain 10 cm: Worst Pain Possible
Measured: Up to 1 week post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Oct 2024 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RectoceleStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm prospective interventional trial where all participants undergo submucosal fat injections for the treatment of rectocele.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Mohamed Hagagy Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604702
- Sponsor's protocol ID
- MD-260-2022
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in publications will be shared. This includes data on clinical outcomes, participant demographics, and relevant procedural details. Supporting documents, such as the study protocol and statistical analysis plan, will also be made available.
Publications
Shafik IA, Abdelfatah MM, Shafik A Jr, Hagagy E, Ali M. Evaluation of autologous fat injection as a minimally invasive technique for rectocele repair: a prospective pilot study. Tech Coloproctol. 2026 May 1;30(1):58. doi: 10.1007/s10151-026-03322-8.
PubMed 42065829
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Injection for Treatment of Rectocele a Novel Technique for Treatment of Tectocele
- ClinicalTrials.gov ID
- NCT06604702
- Acronym / sponsor ID
- MD-260-2022
- Keywords
- Rectocele, Pelvic Floor Dysfunction, Fat Grafting, Autologous Fat Injection, Obstructive Defecation, Pelvic Organ Prolapse, Vaginal Bulge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
This clinical trial aims to evaluate the effectiveness of autologous fat grafting as a novel treatment for rectocele, a condition characterized by the herniation of rectal tissue into the posterior vaginal wall. Women aged 18 to 60 years with mild to moderate rectocele, presenting with symptoms such as obstructive defecation or vaginal bulge, will undergo submucosal fat injections. The study will assess the procedure\'s ability to alleviate symptoms and reduce prolapse recurrence. This prospective, single-arm trial will be conducted at Cairo University Hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm prospective interventional trial where all participants undergo submucosal fat injections for the treatment of rectocele.
| Arm | Type | Receives |
|---|---|---|
| Fat Injection for Rectocele | Experimental | Procedure: Autologous Fat Injection for RectoceleParticipants in this arm will undergo autologous fat injection as a novel treatment for rectocele. Fat grafts will be harvested from the patient's abdomen, processed to purify the fat, and injected into the submucosal layer of the rectocele through the posterior vaginal wall. This procedure aims to reduce the size of the rectocele, alleviate symptoms like vaginal bulge and obstructive defecation, and prevent recurrence. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients aged between 18 and 60 years.
- Diagnosis of rectocele confirmed by defecography, with a rectocele size of 2 cm (mild) to 4 cm (moderate).
- Presenting with symptoms of obstructive defecation syndrome, including constipation, incomplete defecation, and/or vaginal bulge.
- Able to provide written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Patients who have previously undergone surgical repair of rectocele.
- Presence of thrombosed hemorrhoids.
- History of sclerotherapy injection for rectocele.
- Diagnosis of anal stenosis.
- History of coagulopathy or current use of anticoagulant or antiplatelet medications.
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 |
|---|---|---|
| Autologous Fat Injection for RectoceleIn this procedure, autologous fat is harvested from the patient\'s lower abdomen using a multiport cannula. The fat is then processed via centrifugation to separate the viable fat cells, which are emulsified into nanofat. This nanofat is injected into the submucosal layer of the rectocele through the posterior vaginal wall, using an anoscope for guidance. The procedure is intended to reinforce the rectovaginal fascia, alleviate rectocele symptoms such as obstructive defecation and vaginal bulge, and reduce prolapse recurrence. | Procedure or surgery | Fat Injection for Rectocele |
Primary outcome
Reduction in Rectocele Size
Time frame: 6 months post-procedure
The outcome will assess the reduction in rectocele size, measured by clinical examination and defecography. Improvement in rectocele grade will be quantified using a standardized rectocele grading scale. Rectocele Grading Scale: Grade 0: No prolapse of the rectal wall into the vaginal canal. Grade 1: Mild prolapse, where the rectal wall descends slightly into the vaginal canal, typically during straining, but does not reach the vaginal introitus. Grade 2: Moderate prolapse, where the rectal wall descends to the level of the vaginal introitus during straining or bowel movements. Grade 3: Severe prolapse, where the rectal wall protrudes beyond the vaginal introitus, visible externally, especially during straining. This scale would be used to assess the reduction in rectocele size over time as part of your primary outcome. You can adjust the wording in the outcome measure description to reflect this specific scale.
Symptom Relief
Time frame: 6 months post-procedure
In this we will evaluate the patient's relief from rectocele-associated symptoms, including vaginal bulge and obstructive defecation. This will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire. The PFDI-20 measures the severity of pelvic floor symptoms on a scale of 0 to 4 for each item, with higher scores indicating greater distress. Unit of Measure: PFDI-20 Symptom Score (0-100, where 0 represents no distress and 100 represents maximum distress)
2 secondary outcomes
Rate of Recurrence of Rectocele
Time frame: 6 months post-procedure
Postoperative Pain
Time frame: Up to 1 week post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42065829Shafik IA, Abdelfatah MM, Shafik A Jr, Hagagy E, Ali M. Evaluation of autologous fat injection as a minimally invasive technique for rectocele repair: a prospective pilot study. Tech Coloproctol. 2026 May 1;30(1):58. doi: 10.1007/s10151-026-03322-8.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in publications will be shared. This includes data on clinical outcomes, participant demographics, and relevant procedural details. Supporting documents, such as the study protocol and statistical analysis plan, will also be made available.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Fat Injection for Rectocele in people with Rectocele and Pelvic Organ Prolapse, run by Cairo University.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam Mohamed Hagagy Mohamed, MSc (01020487095 ext. +2, Eslam22hego@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Rectocele Size (time frame: 6 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06604702, which also lists 1 linked publication.
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 19 Sep 2024.