Fat Injection for Rectocele Treatment: A Novel Approach

Browse trials for

• Rectocele 50
• Pelvic Organ Prolapse 521

Keywords

• Rectocele
• Pelvic Floor Dysfunction
• Fat Grafting
• Autologous Fat Injection
• Obstructive Defecation
• Pelvic Organ Prolapse
• Vaginal Bulge

Rectocele

50 studies on the registry are indexed under Rectocele; 9 are open to participants now.

This study's planned enrollment of 25 is below the median of 62 across 37 interventional studies indexed under Rectocele.

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Study arms

• Experimental
  Fat Injection for Rectocele

  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.

  Procedure: Autologous Fat Injection for Rectocele

Interventions

• ProcedureAutologous Fat Injection for Rectocele

  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.

Primary outcomes

1. 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.

   Time frame: 6 months post-procedure

2. 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)

   Time frame: 6 months post-procedure

Secondary outcomes

1. 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.

   Time frame: 6 months post-procedure

2. 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

   Time frame: Up to 1 week post-procedure

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data will be available beginning 6 months after publication of the primary results and will be available for 2 years.

Access criteria: Access to the de-identified dataset will be granted to researchers who provide a methodologically sound proposal, subject to review and approval by the study team. Proposals should be directed to the principal investigator, and approved proposals will require a data use agreement. Data will be shared via secure data-sharing platforms or repositories.