Trial document




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  DRKS00017517

Trial Description

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Title

Hernia reduction following laparotomy using small stitch abdominal wall closure with or without mesh augmentation

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Trial Acronym

HULC

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URL of the Trial

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Brief Summary in Lay Language

Incisional hernias are one of the most frequent complications following open abdominal surgeries with a rate of 10-30%. Incisional hernias cause additional costs and reduced quality of life. In Germany, more than 51,000 hernia surgeries are performed annually, with a recurrence rate of up to 30%. Therefore, the prevention of incisional hernias is crucial. Technical improvements in recent years, such as the prophylactic insertion of a mesh or the closure of the abdominal wall in the so-called small stitches technique significantly reduce the rate of incisional hernias.
The aim of the HULC study is to investigate whether the combination of both techniques leads to an additional reduction of hernia rates. The primary end point is the hernia rate within 24 months after the operation. Other endpoints include surgical site infections, 30-day morbidity and quality of life.

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Brief Summary in Scientific Language

Incisional hernias (IHs) are among the most frequent complications following abdominal surgery causing substantial morbidity and mortality. Despite studies on the optimal closing technique for laparotomies IH rates following abdominal surgery are reported to be between 10-30% in RCTs and rise up to 36% in certain subgroups.
In Germany, more than 51,000 IH repairs are performed each year making it one of the most frequent operations.
A recent multicentre RCT has verified the superiority of abdominal closure in small stitches technique using a slowly absorbable suture and an increased suture-length to wound-length ratio of ≥ 4 in terms of reduced IH frequency in comparison to standard abdominal wall closure. Another promising strategy to prevent IHs is the placement of a prophylactic mesh during primary fascial closure. The objective of the HULC trial is to investigate whether prophylactic onlay mesh augmentation (OMA) in addition to abdominal wall closure in small stitches technique (SST) reduces the rate of IH formation in patients undergoing elective midline laparotomy compared to SST alone.

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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

  •   DRKS00017517
  •   2019/06/24
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  •   yes
  •   Approved
  •   S-361/2019, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1233-8181 
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Health Condition or Problem studied

  •   Scheduled elective abdominal operation via a midline laparotomy
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Interventions/Observational Groups

  •   Closure of the midline incision with a slowly absorbable monofilament suture in small stitches technique and additional onlay mesh augmentation using a polypropylene mesh
  •   Closure of the midline incision with a slowly absorbable monofilament suture in small stitch technique
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Incisional hernia rate within 24 months after intervention as defined by the European Hernia Society

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Secondary Outcome

1. Rate of superficial and deep surgical site infections according to Centers for Disease Control (CDC) criteria within one year in both groups;
2. Postoperative (30 day) morbidity according to the Dindo-Clavien classification;
3. Rate of non-infectious wound complications (hematoma, seroma) within 30 days after index Operation;
4. Rate of postoperative burst abdomen defined as missing continuity of the fascia in combination with wound dehiscence with consecutive reoperation within 30 days after index oeration;
5. Postoperative wound pain according to the numeric rating scale on postoperative days 5-7 and 30-35;
6. Quality of life measured with the SF-36 and EQ-5D questionnaires at baseline and at postoperative months 6, 12, and 24;
7. Length of postoperative hospital stay after index operation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/08/12
  •   812
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. Elective abdominal operation via a midline laparotomy
2. Planned clean or clean-contaminated operations according to the Centre for Disease Control (CDC) definition
3. Patient age at least 18 years
4. Ability to understand the nature and extent of the trial and to give written informed consent.
5. Written informed consent
6. Life expectancy at least 2 years

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Exclusion Criteria

1. American Society of Anaesthesiologists (ASA) grade > 3
2. Pregnant or lactating woman
3. Midline laparotomy within the last 60 days prior to trial intervention
4. Previous incisional abdominal hernia or fascial dehiscence
5. Planned relaparotomy via the midline incision within 2 years after trial intervention
6. Concurrent abdominal wall infections
7. Participation in another intervention-trial with interference of intervention and/or outcome of this study

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  PD Dr. med.  André L.  Mihaljevic 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  PD Dr. med.  André L.  Mihaljevic 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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