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Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias

NCT03255239 — Not applicable, Unknown, 120 participants, Hôpital Universitaire Taher Sfar

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Randomized Clinical Trial Comparing Open Preperitoneal Mesh, Retromuscular Mesh and Suture Repair for Abdominal Wall Hernias Less Than 3 cm Diameter

RegistryNCT03255239
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment120 (Estimated)
SponsorHôpital Universitaire Taher Sfar (Other gov)
ConditionsVentral Hernia, Ventral Incisional Hernia, Umbilical Hernia
InterventionsVentral hernia repair (Procedure)
Datesstart 2017-08-01, primary completion 2017-08-01, completion 2019-12-31 (estimated), first posted 2017-08-21, last updated 2017-08-23
Locations1 site in Tunisia

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-Summary

Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Preperitoneal mesh repairExperimentalProcedure: Ventral hernia repairVentral hernia repair using polyester preperitoneal mesh repair
Retromuscular mesh repairExperimentalProcedure: Ventral hernia repairVentral hernia repair using polyester retromuscular mesh repair
Suture repairExperimentalProcedure: Ventral hernia repairVentral hernia repair using suture repair
  • Ventral hernia repair (Procedure), also known as retromuscular mesh repair, preperitoneal mesh repair, suture hernia repair: Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.

+Outcome measures

Primary outcomes

  • Recurrence rates [One year]: Late complications of ventral hernia repair

Secondary outcomes

  • Operating time [15 to 90 minutes]: operating time evaluated as skin-to-skin time
  • Early complication [30 days]: Early complicaion including seroma and hematoma formation, wound infection and fistula
  • Postoperative pain [6, 12 and 24 hours]: Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit

+Eligibility

Sex: All, ages: 18 Years to 90 Years, accepts healthy volunteers

Inclusion Criteria:

* Vebtral hernia or post incisional hernia diameter < 3 cm
* Male or female aged between 18 and 90 year-old
* Elective surgery for ventral hernia

Exclusion Criteria:

* Any contraindication to the prosthetic treatment.
* Any hernia or incisional hernia with a collar strictly greater than 3 cm.
* Previous hernia mesh repaired
* contraindication for general anaesthesia
* Pregnancy

+Locations (1)

FacilityCityCountryStatus
Taher Sfar HospitalMahdiaTunisiaRecruiting

My Notes