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OpenTrials
Completed

NCT Number: NCT01280370

Prospective Evaluation of Laparoscopic and Open Incisional Hernia Repair: a Multicenter Cohort Study

Nowadays incisional hernia are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study.

With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure.

Hypothesis:

Laparoscopic incisional hernia repair is associated with a lower recurrence rate compared to open incisional hernia repair.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Visceral and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

About this study

Background

Incisional hernia is a common long-term complication following abdominal surgery and is estimated to occur in 11-23% 1-3. Incisional hernia can be repaired by an open or by a laparoscopic approach. For incisional hernia prosthetic meshes are nowadays implanted for virtually all open and laparoscopic procedures.

The use of laparoscopy for the treatment of incisional hernia was first reported in 1993 by LeBlanc and Booth 4. Short term follow-up studies show that laparoscopic surgery is associated with decreased postoperative pain, reduced risks of surgical site infections due to minimal tissue dissection, a shorter length of hospital stay and a shorter overall recovery period 5-9.

Important long- term outcome parameters are recurrence rate and chronic pain 10,11. Recurrence after incisional hernia repair varies widely and ranges from 1% to 35% 1,3. Morbid obesity, a previous failed open repair, large defect size and postoperative complications are associated with an increased risk for recurrence 12. Heterogeneity of hernia size and follow-up further complicate comparison of the recurrence rate between different techniques. On average, 74% of recurrences occur within the first 3 years after initial repair 13. Series with an acceptable follow-up of at least 24 months report a recurrence rate in open and laparoscopic repair of approximately 10% 1. Currently, no well designed prospective study is available comparing the incidence of recurrence between open and laparoscopic incisional hernia repair.

Such variability of patients characteristics, surgical techniques and surgical skills are likely to confound a prospective randomized trial. Consequently, a cohort study is performed allowing each surgeon to perform the technique he is most familiar with.

The aim of this multicenter cohort study is to assess the incidence of recurrence 36 months after open and laparoscopic incisional hernia repair, performed in swiss hospitals.

Objective

All patients undergoing elective incisional hernia repair who meet the inclusion criteria (see below) are eligible for inclusion into the study. These patients will be informed about the details of the study preoperatively. After a patient has agreed to enroll into the study and has signed written informed consent, he/she will be advised to attend follow-up assessments according to the study plan.

Methods

All patients undergoing elective incisional hernia repair who meet the inclusion criteria (see below) are eligible for inclusion into the study. These patients will be informed about the details of the study preoperatively. After a patient has agreed to enroll into the study and has signed written informed consent, he/she will be advised to attend follow-up assessments according to the study plan.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 18 years old
  • Written informed consent
  • Primary or recurrent incisional hernia

Exclusion criteria

  • Systemic or severe local infections
  • Emergency procedures

Treatment and study plan

Abdominal surgery

Procedure

intraoperative mesh implantation

Primary outcomes

  1. recurrence rate

    Time frame: 36 months

Secondary outcomes

  1. surgical site infections

    Time frame: 36 months

  2. chronic pain

    Time frame: 36 months

  3. length of hospital stay

    Time frame: 3 months

  4. morbidity

    Time frame: 3 months

  5. cosmetic results

    Time frame: 36 months

  6. rigidity of the abdominal wall

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Prospective Evaluation of Laparoscopic and Open Hernia Repair: a Multicenter Cohort Study

Acronym: IHR_SALTC

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Jan 20, 2011
Registry last updated
Feb 15, 2019

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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