Does the repair of hernia in patients with a ventral hernia with either tacks or sutures improve pain and mobility of patients?

Laparoscopic Articulated Continuous Suture vs tacks in patients with a ventral hernia repair, a randomised controlled trial to assess pain and mobility post-operatively.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000643875

Acronym

ERACS

Enrollment

Registered

2021-05-28

Start date

2021-07-23

Completion date

2022-07-28

Last updated

2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A hernia is a bulge of bowel or other abdominal organs through a weakness in the abdominal wall muscles. A ventral hernia is a type of hernia through the abdominal wall which appears in the middle of your abdomen. It may appear as a lump or bulge, and over time may increase in size and cause pain. This type of hernia can be caused by previous abdominal surgery, weak abdominal muscles, heavy lifting, pregnancy and other causes of weakness of the abdominal wall. When required, a hernia may be repaired surgically using either keyhole surgery (laparoscopic surgery) or a larger incision (open surgery). The goal of surgery is to repair the weakness in the abdominal wall to prevent the abdominal contents protruding through and causing a bulge and pain, and preventing strangulation of those abdominal contents. As part of the procedure, it is standard practice to place a supporting sheet of mesh to act as a reinforcing patch and to help strengthen the abdominal wall and keep the abdominal contents in place. Surgeons can use either sewing stitches (sutures) or tacks (small metallic fixtures) to secure this patch in place. Both of these methods are routinely used in this type of operation. The purpose of this study is to to see if suture repain is less painful than the tack repair and improve mobility for patients following this procedure. We will do this by comparing the two different surgical techniques used to secure the mesh in place.

Interventions

Suture fixation of surgical mesh to the abdominal wall during repair of ventral hernia. Procedure to be performed by a general surgeon who has completed at least 5 of these procedures as a consultant surgeon. Procedure duration is 30-60 minutes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All patients undergoing an elective laparoscopic repair of ventral hernia will be included provided they meet the following criteria: • Age 18 years or over • Provide written consent to participate in the study • Hernia defect size of 2-10cm as measured intra-operatively with insufflation pressure of 12mmHg • Hernia considered suitable for laparoscopic repair with either suture or tack fixation of mesh by operating surgeon • Proposed permanent coated mesh determined to be suitable for intra-peritoneal placement by the treating surgeon

Exclusion criteria

Patients will be excluded from the trial if they meet the following exclusion criteria: • Recurrent hernia with previous intraperitoneal mesh • Known allergic reaction to bupivacaine or ropivacaine • Large (>10cms) hernias not suitable for laparoscopic repair • Umbilical defects most appropriate for open primary suture repair • Incarcerated, strangulated or obstructed hernias booked as emergency cases.

Outcome results