A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy (POP-01)
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ClinicalTrials.gov Identifier: NCT04564677 |
Recruitment Status :
Recruiting
First Posted : September 25, 2020
Last Update Posted : October 10, 2023
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Sponsor:
Duomed
Information provided by (Responsible Party):
Duomed
Tracking Information | |||||||||
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First Submitted Date | September 3, 2020 | ||||||||
First Posted Date | September 25, 2020 | ||||||||
Last Update Posted Date | October 10, 2023 | ||||||||
Actual Study Start Date | February 8, 2021 | ||||||||
Estimated Primary Completion Date | November 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy | ||||||||
Official Title | A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy | ||||||||
Brief Summary | 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 | Not Provided | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy. | ||||||||
Condition |
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Intervention | Device: 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.
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Study Groups/Cohorts | Patients eligible for laparoscopic ventral mesh rectopexy
Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy (LVMR)
Intervention: Device: Ifabond (Péters surgical)
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
150 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 31, 2025 | ||||||||
Estimated Primary Completion Date | November 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Belgium | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT04564677 | ||||||||
Other Study ID Numbers | DM-ZOL-02 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Duomed | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor | Duomed | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | Duomed | ||||||||
Verification Date | October 2023 |