Trial document




This trial has been registered retrospectively.
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  DRKS00013122

Trial Description

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Title

Prospective trial to assess the incidence of trocar-site hernias after laparoscopic bariatric procedures between patients that received closure of the fascia and the skin and patients who received closure of the cutaneous incision

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Trial Acronym

HERBALS (HErnia after BAriatric Laparoscopic Surgery)

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URL of the Trial

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Brief Summary in Lay Language

Hernias can develop after laparoscopic operations of the abdomen. The risk of developing a hernia is bigger after open surgery than after laparoscopic surgery. With this trial we plan to investigate the incidence of hernias following laparoscopic weight-loss surgery between patients where both abdominal layers were sutured after the operation and patients where only the skin incision was closed after the operation.
Patients who have received a laparoscopic weight-loss operation in our department between 2009 and 2016 will be eligible for enrollment in our trial.
All patients who have undergone weight-loss surgery in our clinic regularly visit our outpatient unit for follow-up examinations. The follow-up after weight-loss surgery involves a clinical examination and an ultrasonography of the abdomen. During this scheduled ultrasonography we are planning to examine the abdominal wall for hernias.

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Brief Summary in Scientific Language

Incisional hernias can develop after laparoscopic surgery. The risk of developing incisional hernias is probably higher after bariatric surgery, since the comorbidities of the bariatric patient (diabetes) can negatively influence the healing procedure. Furthermore, closing the fascia after the removal of the trocars is a challenging issue in the bariatric patient.
The incidence of trocar-site hernias in the bariatric population has been estimated to be 1-2%. However, a recently published prospective trial reported an incidence of up to 40%.
The precise estimation of the incidence of trocar site hernias after laparoscopic surgery is yet not possible. The question of closing both the fascia and the skin incision after bariatric surgery or only the skin incision is a very controversely discussed topic which appears in almost every bariatric meeting. Retrospective trials show similar trocar site hernia incidence in patients with closure of the fascia and the skin and patients with closure of the skin.
The european Guidelines for abdominal wall closure published 2 years ago did not offer specific recommendations on this issue, since the available literature is not adequate in order to be able to provide evidence.
New, high quality studies are necessary in this field. From the one side, complications of bariatric surgery have to be reduced to the minimum taking the high complication rate of interventions in the bariatric population into account. From the other side, fascia closure in the bariatric patient is associated with a relevant prolongation of the operative time and therefore, increasing rates of cardiorespiratory complications.
The aim of this prospective trial is to assess the incidence of trocar site hernia after bariatric procedures and to analyse if there is difference in the incidence between patients where only the Skin incision was closed and patients where both the skin and the underlying fascia were closed.
Eligible for enrollment are all patients who where operated laparoscopically for weight-loss in our department between 2009 and 2016. Every patient who has been operated in our department stays in a long-term follow-up. This follow-up includes clinical examination and ultrasonography of the abdomen. In this trial we are planning to examine all trocar insertion places for trocar site hernia after the laparoscopic bariatric procedure. This examination will be performed during the regular follow-up appointment of the patient in our outpatient clinic.

In July 2019 and after the end of the recruitment period we observed that a big number of our patients had surgery in the upper abdomen. This type of surgery makes the evaluation of trocar hernias caused by the bariatric procedure confusing. We therefore added the exclusion criteria 2-5 in order to allow for a more objective definition of the trocar hernias and the incidence of it. Furthermore, during the recruitment phase we detected that patients after abdominoplasty can be examined without problems using sonography. For this reason, the exclusion criterion 'patients after abdominoplasty' was removed.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013122
  •   2018/01/17
  •   [---]*
  •   yes
  •   Approved
  •   2017-593N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K43 -  Ventral hernia
  •   E66.02 -  [generalization E66.0: Obesity due to excess calories]
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Interventions/Observational Groups

  •   Patients, where both the skin incision and the underlying fascia were closed during the laparoscopic bariatric surgery. Using sonography scans, we are planing to examine the trocar insertion wounds for trocar associated hernias.
  •   Patients, where only the skin incision was closed during the laparoscopic bariatric surgery. Using sonography scans, we are planing to examine the trocar insertion wounds for trocar associated hernias.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Blinded
  •   investigator/therapist
  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint is the Incidence of trocar-site hernias after bariatric surgery considering the fascia closure as a possible influence factor. The primary endpoint will be evaluated using sonography scan and a minimum follow- up of one year after the operation.

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Secondary Outcome

Secondary endpoint is to detect how many patients actually have a symptomatic defect of the fascia and how many a symptomatic incisional hernia.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/08/01
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients who have undergone bariatric surgery in our department between 2009 and 2016

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Exclusion Criteria

1. Patients who are not able of consenting to the Trial
2. Patients with follow-up shorter than 9 months after the bariatric procedure
3. Patients with lalaparoscopic surgery in the upper abdomen before the bariatric procedure
4. Patients with any type of midline or transverse laparotomy in the upper abdomen before or after the bariatric procedure
5. Patients with procedures implementing implantable devices penetrating the fascial layer

After completing the recruitment (July 2019) we revised the exclusion criteria. The added ones are presented in number 2-5. The reason for the revision was to enable a more objective evaluation of the primary endpoint and reduce the bias.
Furthermore, the preexisting exclusion criterion 'patients after abdominoplasty' was removed because during the study we observed that these patients can be examined using sonography scans without any problems.

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Addresses

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    • Chirurgische Klinik, Universitätsmedizin Mannheim
    • Mr.  PD Dr.med.  Mirko  Otto 
    • Theodor-Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
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    •   0049-621-383-2225
    •   0049-621-383-3809
    •   mirko.otto at umm.de
    •   [---]*
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    • Chirurgische Klinik, Universitätsmedizin Mannheim
    • Mr.  Dr. med.  Ioannis  Karampinis 
    • Theodor-Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Chirurgische Klinik, Universitätsmedizin Mannheim
    • Mr.  PD Dr.med.  Mirko  Otto 
    • Theodor-Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address scientific-contact
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    •   0049-621-383-2225
    •   0049-621-383-3809
    •   mirko.otto at umm.de
    •   [---]*
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    • Chirurgische Klinik, Universitätsmedizin Mannheim
    • Mr.  PD Dr.med.  Mirko  Otto 
    • Theodor-Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address public-contact
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    •   0049-621-383-2225
    •   0049-621-383-3809
    •   mirko.otto at umm.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Chirurgische Klinik, Universitätsmedizin Mannheim
    • Mr.  PD Dr. med.  Mirko  Otto 
    • Theodor-Kutzer Ufer 1-3
    • 68167  Mannheim
    • Germany
    end of 1:1-Block address materialSupport
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    •   0049-621-383-2225
    •   0049-621-383-3809
    •   mirko.otto at umm.de
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2019/05/12
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.