Trial document





This trial has been registered retrospectively.
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  DRKS00008020

Trial Description

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Title

Single versus Multiple Layer Closure for Supracostal Incision

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Trial Acronym

SIMULAC

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Single versus Multiple Layer Closure for Flank Incision

The supracostal incision is a common access for retroperitoneal organs in urology. It allows for instance operations on the kidney such as partial nephrectomies. One major drawback is the high occurance of flank bulges (up to 50%) of after surgery due to injury of muscles and nerves. Generally wound closure is performed in layers with multiple sutures that possibly lead to further nerval damage. One alternative is to only suture the external fascial layer, which is the most relevant fascial stabilization structures.

Aim of the study is to compare the multiple layer closure and the single layer closure. We expect a reduction in flank bulges without an higher risk of postoperative herniation.

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Brief Summary in Scientific Language

Aim of the study is the comparison of a single layer versus a multiple layer wound closure after supracostal incision in terms of posoperative flank bulge and hernia.


The supracostal incision is ommon for surgery on retroperitoneal organs. It is considered to be the gold standard for kidney and upper urinary tract surgery in modern urology. Wound closure is generally performed in layers to adapt the different muscofascial layers. Frequent complications after supracostal incision are flank bulges, chronic neuralgia and hernia. The aim of the SIMULAC study is to access whether a single (external) layer closure reduces the risk of flank bulges and chronic neuralgia without harboring the risk of an increased number of hernia.
Generally supracostal incision is performed above the 11th or 12th rip and requires the sectioning of three muscle layers with the respective fascia. Branches of nerves that innervate the muscles of the lateral abdominal wall run between the layers and can possibly be damaged during incision. Anatomical studies suggest that this may cause flank bulges. Data regarding the incidence and risk factor for flank bulges is not sufficient. A retrospective Analysis of 100 patients undergoing an operation with supracostal incision found almost 50% of flank bulges and chronic neuralgia. Herniation was found in 7% of the cases, which is comparable to what has been described for median laparotomy (1,2).

Up to now the reason for flunk bulges is believed to be due to the indispensable sectioning of nerve branches during the incision and hernia due to insufficient wound closure or poor tissue quality. It is easily conceivable that an additional damage of the nerves can happen during the multi-layer closure, as often muscle and soft tissue is captured within the suture. On the other hand the external fascia is believed to be the main stabilization structure of the lateral abdominal wall (3-5). Consequently, the hypothesis of the SIMULAC study is that a single (external) layer closure of the supracostal incision reduces nerve damage and hence the occurrence of lank bulges without an increased rate of herniation.
In summary, there is little evidence on techniques and complications of the supracostal incision. Since it is widely used there is a strong need to access advances and drawbacks of different techniques for wound closure in a prospective randomized multi-institutional study.

1. Chatterjee S, Nam R, Fleshner N, Klotz L. Permanent flank bulge is a consequence of flank incision for radical nephrectomy in one half of patients. Urol Oncol 2004;22:36-9.
2. Honig MP, Mason RA, Giron F. Wound complications of the retroperitoneal approach to the aorta and iliac vessels. J Vasc Surg 1992;15:28-33; discussion -4.
3. Crouzet S, Chopra S, Tsai S, et al. Flank Muscle Volume Changes After Open and Laparoscopic Partial Nephrectomy. J Endourol 2014.
4. Ozel L, Marur T, Unal E, et al. Avoiding abdominal flank bulge after lumbotomy incision: cadaveric study and ultrasonographic investigation. Transplant Proc 2012;44:1618-22.
5. Gardner GP, Josephs LG, Rosca M, Rich J, Woodson J, Menzoian JO. The retroperitoneal incision. An evaluation of postoperative flank 'bulge'. Arch Surg 1994;129:753-6.

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Organizational Data

  •   DRKS00008020
  •   2015/09/14
  •   [---]*
  •   yes
  •   Approved
  •   2015-516N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1169-3244 
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Health Condition or Problem studied

  •   Operations (e.g. open partial nephrectomy) that require a supracostal incision
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Interventions/Observational Groups

  •   Closure of the medial muscle- and fascia-layer (fascia-layer of the external fascia of the m. transversus/Mm. intercostales intimi and the internal fascia of the M. obliquus internus/Mm. intercostales interni with the fascia-layer of the external fascia of the M. obliquus internus/Mm. intercostales interni and the internal fascia of the M. obliquus externus/Mm. intercostales externi) with Vicryl 0 single-knot suture , subsequently closure of the external fascia of the M obliquus externus/Mm. intercostales externi with a continuous PDS-sling (SIMULAC I).
  •   Closure of the external fascia of the M obliquus externus/Mm. intercostales externi with a continuous PDS-sling (SIMULAC II).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Rate of Flank Bulge after 6 months in the clincial examination

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Secondary Outcome

Rate of hernia after 6 months in the clinical examination and variefied in an MRI
Rate of paresthesia/pain after 6 month examined with a visual analog scale

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2015/06/01
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

required operation with a supracostal incision
age ≥ 18
informed consens
expected survival ≥ 12 month

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Exclusion Criteria

immunosupression
drugs or alcohol abusus
current chemotherapy or chemotherapy with in the last two weeks
current radiotherapy of the abdomen or thorax
radiotherapy of the abdomen or thorax within the last six weeks
severe psychiatric disorder
emergency or revision surgery
Infectious diseases
demented or incompliant patient

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Addresses

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    • Universitätsklinikum Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Klinik für UrologieUniversitätsmedizin Mannheim
    • Mr.  Dr.  Maximilian  Kriegmair 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Klinik für UrologieUniversitätsmedizin Mannheim
    • Mr.  Dr.  Maximilian  Kriegmair 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Urology Universitätsmedizin Mannheim
    • Mr.  Prof  Maurice  Michel 
    • Theodor-Kutzer-Ufer 1-3
    • 61867  Mannheim
    • Germany
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Status

  •   Recruiting ongoing
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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.