A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
NCT ID: NCT04564677
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2021-02-08
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients eligible for laparoscopic ventral mesh rectopexy
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR)
Ifabond (Péters surgical)
Ifabond (Péters surgical) is a CE-marked synthetic surgical glue for internal and external use. The glue is non-toxic, biocompatible and biodegradable. It is commercially available and can be used for mesh fixation, as tissue adhesive, for sealing of sutured tissue and for hemostasis.
Interventions
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Ifabond (Péters surgical)
Ifabond (Péters surgical) is a CE-marked synthetic surgical glue for internal and external use. The glue is non-toxic, biocompatible and biodegradable. It is commercially available and can be used for mesh fixation, as tissue adhesive, for sealing of sutured tissue and for hemostasis.
Eligibility Criteria
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Inclusion Criteria
* Patient ≥ 18 years of age at study entry.
* Patient and investigator signed and dated the informed consent form prior to the index-procedure.
* Patient with primary rectal prolapse (grades I to V according to the Oxford scale), rectocele and/or enterocele.
Exclusion Criteria
* Patient with recurrent rectal prolapse, rectocele and/or enterocele.
* Patient is unable to comply with the study protocol or proposed follow-up visits.
* Patient has a contra-indication for laparoscopic ventral mesh rectopexy.
18 Years
FEMALE
No
Sponsors
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Duomed
INDUSTRY
Responsible Party
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Principal Investigators
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Anne Dams, MD
Role: PRINCIPAL_INVESTIGATOR
Ziekenhuis Oost-Limburg (ZOL)
Locations
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Ziekenhuis Oost-Limburg (ZOL)
Genk, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Anne Dams, MD
Role: primary
Other Identifiers
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DM-ZOL-02
Identifier Type: -
Identifier Source: org_study_id
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