An interventional study of Ventral hernia repair in Ventral Hernia, Ventral Incisional Hernia and Umbilical Hernia, sponsored by Hôpital Universitaire Taher Sfar. Status unknown at 1 site in Tunisia. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by Hôpital Universitaire Taher Sfar · Not applicable, Interventional, and Treatment
Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter
Many techniques of ventral hernias repair have been reported. It is shown that open mesh hernia repairs have low recurrence and low complication rates then suture repair. But for hernias less than 3 cm some surgeons defend the treatment by suture. The main variable of interest is the location of mesh placement compared to suture repair. The investigator will compare in a prospective randomized clinical trial three techniques of abdominal wall hernia repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias less than 3 cm. All patients underwent general anesthesia. The investigators used Polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in animal models. Operative notes were physician-abstracted and the presence, type, and location of mesh prosthesis was recorded. Independent variables of interest were patient-level demographics (age and sex), facility where hernia repair occurred, year of hernia repair, preoperative comorbid conditions, history of prior repair, and intraoperative variables. The results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit, operating time evaluated as skin-to-skin time, drain management and both of early and late complications including seroma and hematoma formation, wound infection, fistula formation and recurrence rates.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's planned enrollment of 120 is above the median of 66 across 40 interventional studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →Hôpital Universitaire Taher Sfar is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Hernia, Umbilical, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hernia, Ventral. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Ventral hernia repair using polyester preperitoneal mesh repair
Procedure: Ventral hernia repair
Ventral hernia repair using polyester retromuscular mesh repair
Procedure: Ventral hernia repair
Ventral hernia repair using suture repair
Procedure: Ventral hernia repair
Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.
Also known as: retromuscular mesh repair, preperitoneal mesh repair, suture hernia repair
Recurrence rates
Late complications of ventral hernia repair
Time frame: One year
Operating time
operating time evaluated as skin-to-skin time
Time frame: 15 to 90 minutes
Early complication
Early complicaion including seroma and hematoma formation, wound infection and fistula
Time frame: 30 days
Postoperative pain
Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit
Time frame: 6, 12 and 24 hours
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Hôpital Universitaire Taher Sfar