Fat Injection for Rectocele Treatment: A Novel Approach

NCT06604702 | Not Yet Recruiting

• 1 other identifier: MD-260-2022
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Keywords

Rectocele; Pelvic Floor Dysfunction; Fat Grafting; Autologous Fat Injection; Obstructive Defecation; Pelvic Organ Prolapse; Vaginal Bulge

Outcome Measures

Primary Outcomes (2)

• Reduction in Rectocele Size

  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.

  6 months post-procedure

• Symptom Relief

  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)

  6 months post-procedure

Secondary Outcomes (2)

• Rate of Recurrence of Rectocele

  6 months post-procedure

• Postoperative Pain

  Up to 1 week post-procedure

Study Arms (1)

Fat Injection for Rectocele

EXPERIMENTAL

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.

Procedure: Autologous Fat Injection for Rectocele

Interventions

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.

Fat Injection for Rectocele

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Female patients ageing from 18 to 60 years presenting to general surgery department of Cairo university hospitals complaining of chronic constipation or obstructed defecation syndrome posterior with posterior vaginal bulge and diagnosed with rectocele
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Rectocele; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Prolapse

Central Study Contacts

Eslam Mohamed Hagagy Mohamed, MSc

CONTACT

01020487095; Eslam22hego@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of the General Surgery, Cairo University

Model Details: Single-arm prospective interventional trial where all participants undergo submucosal fat injections for the treatment of rectocele.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 20, 2024
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 6 months after publication of the primary results and will be available for 2 years.
• Access Criteria: Access to the de-identified dataset will be granted to researchers who provide a methodologically sound proposal, subject to review and approval by the study team. Proposals should be directed to the principal investigator, and approved proposals will require a data use agreement. Data will be shared via secure data-sharing platforms or repositories.