Fat Injection for Rectocele Treatment: A Novel Approach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Fat Injection for Rectocele.
- Who it may be relevant to
- Registry conditions: Rectocele, Pelvic Organ Prolapse, Obstructive Defecation Syndrome. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fat Injection for Treatment of Rectocele a Novel Technique for Treatment of Tectocele
Overview
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.
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 bu
Primary outcome measures
- Reduction in Rectocele Size [Time frame: 6 months post-procedure]
- Symptom Relief [Time frame: 6 months post-procedure]
Secondary outcome measures (2)
- Rate of Recurrence of Rectocele [Time frame: 6 months post-procedure]
- Postoperative Pain [Time frame: Up to 1 week post-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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Shafik IA, Abdelfatah MM, Shafik A Jr, Hagagy E, Ali M. Evaluation of autologous fat injection as a minimally invasive technique for rectocele repair: a prospective pilot study. Tech Coloproctol. 2026 May 1;30(1):58. doi: 10.1007/s10151-026-03322-8. PMID 42065829
Identifiers
NCT: NCT06604702 · MD-260-2022