Fat Injection for Rectocele Treatment: A Novel Approach

NCT ID: NCT06604702

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2025-10-20

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.

Conditions

Rectocele; Pelvic Organ Prolapse; Obstructive Defecation Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Autologous Fat Injection for Rectocele

Intervention Type: 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.

Interventions

Autologous 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Eslam Mohamed Hagagy Mohamed

Resident of the General Surgery, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Eslam Mohamed Hagagy Mohamed, MSc

Role: CONTACT

Eslam22hego@gmail.com

01020487095 ext. +2

Other Identifiers

MD-260-2022

Identifier Type: -

Identifier Source: org_study_id