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NCT Number: NCT06604702

Fat Injection for Rectocele Treatment: A Novel Approach

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.

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Key information

Conditions

Rectocele Digestive System Diseases Gastrointestinal Diseases Hernia Intestinal Diseases Obstructive Defecation Syndrome Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Fat Injection for Rectocele

Procedure

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

    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.

  2. 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)

Secondary outcomes

  1. Rate of Recurrence of Rectocele

    Time frame: 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.

  2. Postoperative Pain

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eslam Mohamed Hagagy Mohamed, MSc

CONTACT

[email protected]

01020487095 ext. +2

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Fat Injection for Treatment of Rectocele a Novel Technique for Treatment of Tectocele

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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