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

This study is currently recruiting participants.
Verified March 2014 by University Hospital Inselspital, Berne
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01280370
First received: January 19, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Incisional Hernia Repair
Procedure: Abdominal surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Laparoscopic and Open Hernia Repair: a Multicenter Cohort Study

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • recurrence rate [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • surgical site infections [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • chronic pain [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • length of hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • morbidity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • cosmetic results [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • rigidity of the abdominal wall [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: September 2010
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
1.patients treated in a laparoscopic manner
2.
2. patients treated in open operative manner
Procedure: Abdominal surgery
intraoperative mesh implantation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients undergoing incisional hernia repair

Criteria

Inclusion Criteria:

  • patients over 18 years old
  • written informed consent
  • primary or recurrent incisional hernia

Exclusion Criteria

  • systemic or severe local infections
  • emergency procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280370

Contacts
Contact: Beldi 0041 31 632b85 92 guido.beldi@insel.ch
Contact: Barbara Uhlmann, Study Nurse 0041 31 632 23 26 barbara.uhlmann@insel.ch

Locations
Switzerland
Dep. of Visceral and transplant surgery, Berne University Hospital Recruiting
Berne, Switzerland, 3010
Contact: Guido Beldi, PD Dr. med.    0041 31 632 82 75    guido.beldi@insel.ch   
Principal Investigator: Guido Beldi, PD Dr. med.         
Sub-Investigator: Anita Kurmann, Dr. med.         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Beldi Berne, University Hospital, University of Beren, Switzerland
  More Information

No publications provided

Responsible Party: PD Dr. med. Guido Beldi, Insel, University Hospital
ClinicalTrials.gov Identifier: NCT01280370     History of Changes
Other Study ID Numbers: 231/09
Study First Received: January 19, 2011
Last Updated: March 3, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
Incisional hernia repair

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 17, 2014