Fat Injection for Rectocele Treatment: A Novel Approach

NCT06604702 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-20
Primary Completion
2025-10-20
Completion
2025-10-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604702 on ClinicalTrials.gov