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OpenTrials
Completed

NCT Number: NCT01132209

Suture Techniques to Reduce the Incidence of The inCisional Hernia

The objective of the study is reduction of the incidence of the most frequent complication of abdominal surgery, incisional hernia. In this multi center double-blinded prospective randomized controlled trial, in which a new suture technique using small bites is compared with the traditionally applied large bites (mass closure) technique for midline incisions.

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Key information

Conditions

Hernia Burst Abdomen Incisional Hernia Infections Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Quality of Life Signs and Symptoms Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3000CA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • All laparotomies with a midline incision
  • Age > 18 years

Exclusion criteria

  • Previous incisional hernia after midline incision
  • Previous surgery through a midline incision within 3 months
  • Pregnancy (in women)

Treatment and study plan

Closure of the abdominal wall after midline incisions

Procedure

Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques

Primary outcomes

  1. Incisional hernia occurrence within one year after operation clinical and/or radiographically detected

    Time frame: one year

Secondary outcomes

  1. postoperative complications; in particular wound infection (during admission), burst abdomen (during admission) and wound pain (measured with a visual analog scale (VAS) during the first 6 days after surgery).

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Elisabeth-TweeSteden Ziekenhuis
  • Groene Hart Ziekenhuis
  • Havenziekenhuis
  • Kennemer Gasthuis
  • Meander Medical Center
  • Red Cross Hospital Beverwijk
  • Rijnstate Hospital
  • Sint Franciscus Gasthuis
  • Vlietland Ziekenhuis

Registry information

Acronym: STITCH

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
May 27, 2010
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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