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

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03255239
• Other study ID #: Abdominal wall hernia repair
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2017
• Last updated: August 22, 2017
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2017
• Source: Hôpital Universitaire Taher Sfar
• Contact: Moez Boudokhane, MD
• Phone: 98461511
• Email: Moez-chir[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2019
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Hernia, Ventral
• Incisional Hernia
• Umbilical Hernia
• Ventral Hernia
• Ventral Incisional Hernia

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Taher Sfar Hospital	Mahdia

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Universitaire Taher Sfar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rates	Late complications of ventral hernia repair	One year
Secondary	Operating time	operating time evaluated as skin-to-skin time	15 to 90 minutes
Secondary	Early complication	Early complicaion including seroma and hematoma formation, wound infection and fistula	30 days
Secondary	Postoperative pain	Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit	6, 12 and 24 hours