A Phase 3 interventional study of Umbilical port placement and Paraumbilical port placement in Incisional Hernia, sponsored by Hospital General Universitario Elche. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-09.
Sponsored by Hospital General Universitario Elche · Phase 3, Interventional, and Prevention
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.
Patients will be randomized into 2 groups:
Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.
Patients will be randomized into 2 groups:
Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's planned enrollment of 180 is above the median of 110 across 130 interventional studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →Hospital General Universitario Elche is the lead sponsor of 44 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers.
Procedure: Umbilical port placement
A bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle.
Procedure: Paraumbilical port placement
The port will be inserted in the midline at the level of the umbilicus.
The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus.
Incisional hernia at the level of the trocar insertion
The incisional hernia at the level of the umbilical or paraumbilial trocar insertion will be assessed by physical examination, or with ultrasonography in case of doubts.
Time frame: 12 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2020 (actual). Primary completion is estimated for Sep 2021, 14 months after the start.
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Hospital General Universitario Elche