Fat Injection for Rectocele Treatment: A Novel Approach

Not Applicable

Not yet recruiting

• Conditions: Rectocele; Pelvic Organ Prolapse; Obstructive Defecation Syndrome
• Interventions: Procedure: Autologous Fat Injection for Rectocele

• Registration Number: NCT06604702
• Lead Sponsor: Cairo University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-20
• Primary Completion: 2025-10-20
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fat Injection for Rectocele	Autologous 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.

Primary Outcome Measures

Name	Time	Method
Reduction in Rectocele Size	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	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)

Secondary Outcome Measures

Name	Time	Method
Rate of Recurrence of Rectocele	6 months post-procedure	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.
Postoperative Pain	Up to 1 week post-procedure	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