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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-08

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.

Detailed Description

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Conditions

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Rectocele Enterocele Rectal Prolapse

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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)

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female patients.
* 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 is unable / unwilling to provide informed consent.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Duomed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Stephanie De Munter, PhD

Role: CONTACT

+32 (0)11 28 69 48

Anne Dams, MD

Role: CONTACT

+32 (0)89 32 60 20

Facility Contacts

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Anne Dams, MD

Role: primary

+32 (0)89 32 60 20

Other Identifiers

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DM-ZOL-02

Identifier Type: -

Identifier Source: org_study_id

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