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Status unknownNCT03255239Updated Aug 23, 2017

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

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

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Ventral Hernia
  • Ventral Incisional Hernia
  • Umbilical Hernia

Keywords

  • ventral hernia
  • Open mesh repair
  • Polyester mesh
  • Preperitoneal
  • Retromuscular
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Preperitoneal mesh repair

    Ventral hernia repair using polyester preperitoneal mesh repair

    Procedure: Ventral hernia repair

  • Experimental
    Retromuscular mesh repair

    Ventral hernia repair using polyester retromuscular mesh repair

    Procedure: Ventral hernia repair

  • Experimental
    Suture repair

    Ventral hernia repair using suture repair

    Procedure: Ventral hernia repair

Interventions

  • ProcedureVentral 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

05

What researchers measure

Primary outcomes

  1. Recurrence rates

    Late complications of ventral hernia repair

    Time frame: One year

Secondary outcomes

  1. Operating time

    operating time evaluated as skin-to-skin time

    Time frame: 15 to 90 minutes

  2. Early complication

    Early complicaion including seroma and hematoma formation, wound infection and fistula

    Time frame: 30 days

  3. 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

06

Study locations

1 of 1 sites recruiting
  • Taher Sfar Hospital
    Mahdia, 5100, Tunisia
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03255239
Lead sponsor
Hôpital Universitaire Taher Sfar
Responsible party
Mohamed Ali Chaouch (Resident of general surgery, Hôpital Universitaire Taher Sfar) — Principal investigator
First posted
Aug 21, 2017
Start date
Aug 1, 2017
Primary completion
Aug 1, 2017
Completion
Dec 31, 2019 (estimated)
Last update
Aug 23, 2017

Study contacts

Moez Boudokhane, MD
Contact
Moez-chir@yahoo.fr
98461511 ext. +216
Mohamed Ali Chaouch, RD
Contact
Docmedalichaouch@gmail.com
26205105 ext. +216

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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