INCH-trial: A multicenter randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional-hernia repair.

INCH-trial: A multicenter randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional-hernia repair. - INCH-trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41404

Enrollment

250

Registered

2011-08-11

Start date

2012-08-01

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

ventral hernia/ incisional hernia

Interventions

Patients will either undergo laparoscopic or open incisional hernia repair. There two groups will be compared.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who: - have an incisional hernia - the need/wish for surgical repair - laparoscopic repair is feasible gave informed consent

Exclusion criteria

Exclusion criteria: Patients who: - Are pregnant - Have an ostomy - Are younger than 18 years old have an open abdomen treatment in the medical history.

Design outcomes

Primary

Measure	Time frame
Primary outcomes are: -Length of hospital stay -Quality of life measures through SF-36 and CCS.	—

Secondary

Measure	Time frame
Secondary endpoints are: - Time to full recovery within a three months period. -Re-operation rate for recurrence or complications of the incisional hernia repair. The analysis will be continued after the cost-effectiveness study has ended, a longer follow-up is needed to examine the recurrence-rate. -28 days post surgery morbidity and mortality, -Shape of the abdomen: a digital photograph of the abdomen using raster-stereography will be taken pre- and post-operatively to analyse the change in the abdominal shape. -Total mean costs will be related to the following effect measures in the cost-effectiveness analyses: 1) Time to full recovery 2) Quality-adjusted life-years (QALYs) based on the SF-36.	—

Measure

Time frame

Secondary endpoints are: - Time to full recovery within a three months period. -Re-operation rate for recurrence or complications of the incisional hernia repair. The analysis will be continued after the cost-effectiveness study has ended, a longer follow-up is needed to examine the recurrence-rate. -28 days post surgery morbidity and mortality, -Shape of the abdomen: a digital photograph of the abdomen using raster-stereography will be taken pre- and post-operatively to analyse the change in the abdominal shape. -Total mean costs will be related to the following effect measures in the cost-effectiveness analyses: 1) Time to full recovery 2) Quality-adjusted life-years (QALYs) based on the SF-36.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)