Fat Injection for Rectocele Treatment: A Novel Approach

Cairo University (CU)

Status: Not yet enrolling

Conditions: Pelvic Organ Prolapse; Obstructive Defecation Syndrome; Rectocele

Treatments: Procedure: Autologous Fat Injection for Rectocele

Study type: Interventional

Funder types: Other

Identifiers

NCT06604702

MD-260-2022

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Fat Injection for Rectocele

Experimental group

Description:

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.

Treatment:

Procedure: Autologous Fat Injection for Rectocele