An interventional study of Laparoscopic mesh hernia repair and Open anterior approach in Incisional Hernia and Umbilical Hernia, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.
The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.
Five hundred patients will be included in this randomized, multicentric trial.
Hypotheses are that laparoscopic approach: 1- reduces immediate parietal complications without increasing intra abdominal septic complications 2- is less invasive and also reduces patients' hospital stay and recovery time; 3- has the same efficacy, than open approach.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's enrollment of 98 is below the median of 110 across 130 interventional studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
group A: Laparoscopic approach
Procedure: Laparoscopic mesh hernia repair
group B: Open anterior approach
Procedure: Open anterior approach
The mesh is intraperitoneal
Also known as: laparoscpic mesh repair of incisional and umbilical hernia
The mesh is placed by an anterior approach. It is placed after incision of the skin over or under the abdominal muscles, or is intraperitoneal
Also known as: Conventional treatment of incisional and umbilical hernia
Parietal postoperative complications: 1- haematoma, 2- abscess, 3- seroma 4- cutaneous necrosis
Time frame: 2 months
Postoperative intra abdominal complications: peritonitis, occlusion, haemorrhage
Time frame: 2 months
Postoperative pain: measured by a- Visual Analogic Score (VAS 0-10): 1-number of days with VAS > 5; 2- maximal VAS, and b- duration (days) of morphine use
Time frame: 2 months
Postoperative fever > 38°5
Time frame: 2 months
Postoperative ileus
Time frame: 2 months
Postoperative phlebitis
Time frame: 2 months
Postoperative pulmonary embolism
Time frame: 2 months
Postoperative urinary infection
Time frame: 2 months
Duration of hospital stay
Time frame: 2 months
Duration of drainage
Time frame: 2 months
Mesh infection
Time frame: 24 months
Peritonitis due to intraperitoneal mesh
Time frame: 24 months
Occlusion due to intra peritoneal mesh
Time frame: 2 months
Recurrence of incisional or umbilical hernia
Time frame: 24 months
Trocar site hernia
Time frame: 24 months
This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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