Trial document




drksid header

  DRKS00005662

Trial Description

start of 1:1-Block title

Title

Secondary structural Changes of the Rectal Wall in Rectal Prolapse: a Functional Pathological Study on Resection Specimens with Correlation of Clinical Findings

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The rectum assumes a central role as sensory and evacuatory organ for defaecation. Sensory and motoric function of the rectum require intact nerval and muscular organic structures. Conversely, the last decade has brought a growing awareness, better understanding and new treatment options for certain acquired degenerative disorders of the rectum.

In this context the rectal prolapse (a plug-like intussusception of the organ into itself) is in the focus of medical attention. It appears probable that due to mechanical strain on the tissue the prolapse will itself cause secondary damage within the microscopic architecture of the rectal wall which leads to functional impairement. Rectal prolape may therefore also cause permanent rectal dysfunction.

For this study resection specimens of so-called STARR-operations (a procedure for the operative treatment of rectal prolapse) are to be pathologically examined for macro- and micromorphological changes which are then correlated to clinical findings. This is done by a study adapted recording of the clinical data and by detailled histopathological examination of the specimens according to defined functional and neuropthological criteria.

For this study the current clinical practise in diagnosis, indication, operative therapy, and postoperative treatment of patients undergoing a STARR-procedure remains unaltered.

The causal sequence of „prolapse-structural damage-functional deficit“ seems very probable and is the underlying hypothesis of this study.
A clarification of this hypothesis would substantially contribute to our understanding of constipation and incontinence particularly in the elderly. Both disorders have a significant negative impact on the quality of life in the elderly and they are, in this era of „demographic change“, also of considerable socio-economic relevance.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The physiology of defaecation is still not fully understood (12,17,18,21). There is consensus that the perception of increased intraluminal pressure in the rectum perceived by hitherto not unequivocally identified receptors will initiate the urge of defaecation (12, 17,18,21,23). This pressure increase usually occurs rapidly by mass peristalsis mainly from the sigmoid colon. Mass peristalsis can also be initiated by other stimuli such as emotion (13) („fright“), cold temperature, stimulating substances (e.g. coffee).
Above a certain threshold rectal intraluminal pressure initiates the urge to defecate. The threshold for urge appears to be variable and may be influenced by acquired changes of the rectal wall (caused by e.g. inflammatory diseases or radiation, acquired degenerative changes) (15,29,30,32).
Contrary to widely held beliefs a physiologically intact rectum has no role as reservoir. However, with advancing age and acquired degenerative changes and ensuing loss of evacuatory strength it may mimick a stool filled reservoir. During the resting phase of the physiologically intact rectum there appear to be retrograde propulsory motor complexes to tranport smaller amounts of faecal matter back into the sigmoid colon until mass peristalsis from above is initiated (22). Retrograde propulsive activity is also stimulated by the conscious suppression of defecation urge. The rectum also acts as barrier to break colonic peristalsis.which is not propagated into the rectum (21). A chronically stool impacted rectum can therefore be taken as evidence for a functional defect.
Defaecation can be consciously initiated via parasympathic mediation. To evacuate stool the levator and anal sphincters are relaxed which opens the anal canal. The rectum contracts mainly axially. To achieve this „axial contraction“ the colonic tenia spread anatomically over the rectum to form the external layer of the muscularis propria which covers the entire organ. There is however also a transverse contracting peristalsis in the rectum by the inner and more circularly structured layer of the rectal muscularis propria (12,17,18,21). Straining by tensing the abdominal wall musculature supports the evacuation.
The rectum therefore assumes a central role as sensory and evacuatory organ for defaecation. It may conversely be postulated that sensory and motoric function of the rectum require intact nerval and muscular organic structures.
The last decade has brought a growing awareness, better understanding and new treatment options for certain acquired degenerative disorders of the rectum. These changes are mainly agephysiological.and easily diagnosed by simple clinical examination. In this context the inner rectal prolapse is in the focus of medical attention and is recognised as major mechanical cause for obstructed defaecation. Meanwhile this causality has become largely accepted among surgeons as a pathophysiological concept termed „obstructed defaecation syndrome (ODS)“ (1-3,6,7,9,10,19,20,24,25,28).
The inner rectal prolapse is a plug-like intussusception of the rectum in itself. Variants of this are „mucosal prolapse“ which is in essential a precursor of the former, but also „haemorrhoidal prolapse“ which is a frequent and often symptomatic associated disorder. The intussuception acts like a valve which has to be overcome to allow for the passage of stool. Also commonly associated in females are rectoceles. They are a consequence of an often palpable structural degenerative weakness typically of the anterior rectal wall (recto-vaginal septum).
The present discussion of the pathophysiology of obstructed defaecation is by and large limited to the mechanistic aspect of the physical obstruction caused by the plug-like inner prolapse.
Despite this, there have over the years consistently been reports of severe motoric and sensory disturbances of the rectum detected in patients with constipation, defaecatory obstruction and faecal incontinence (4,5,8,11,14,16,26,27,31). Radiological imaging of rectal prolapse patients (particularly by dynamic defaecography) regularly reveals an extremely flaccid and dilated rectum. In addition, these patients very often exhibit high grades of sensibility disturbances and/or evacuatory dysfunctions detected by balloon-expulsion-tests. These dysfunctions very often persist despite operative therapy of the obstructing prolapse.
In this context it appears unlikely that a markedly flaccid and dilated intussuscepting rectum still retains the structural sensori-motoric integrity which is required for physiological defaecation. Conversely, a structurally normal and tight rectum will not be flaccid enough to undergo intussusception. Accordingly, resection specimen of prolapsing rectum frequently appear fibrosed and scarred.
It may therefore be postulated that the mechanics of internal rectal prolapse cause secondary structural trauma within the rectal wall which in turn leads to functional sensori-motoric impairment of rectal function. Thus, rectal prolapse would generally cause a secondary functional deficit (in addition to the mere mechanical obstruction which is hitherto recognised, only). The causal sequence of „prolapse-structural damage-functional deficit“ seems very probable and is the underlying hypothesis of this study.
A clarification of this hypothesis would substantially contribute to our understanding of constipation and incontinence particularly in the elderly. Both disorders have a significant negative impact on the quality of life in the elderly and they are, in this era of „demographic change“, also of considerable socio-economic relevance.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005662
  •   2014/01/21
  •   [---]*
  •   yes
  •   Approved
  •   2013-629-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   K62.3 -  Rectal prolapse
  •   K59.0 -  Constipation
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients who are diagnosed with obstructed defaecation and rectocele/rectal prolapse following the routine preoperative therapeutic and diagnostic protocol and who are indicated for the STARR-procedure. For this study STARR resection specimens are to be pathologically examined for macro- and micromorphological changes which are then correlated to clinical findings. This is done by a study adapted recording of the clinical data and by a detailed histopathological examination of the specimens according to functional and neuropthological criteria.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- rate and extent of histopathologically ascertainable structural impairement and defects in STARR-specimens

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- correlation of documented structural damage with clinical findings, patient age, and sex

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/01/23
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients who are diagnosed with obstructed defaecation and rectocele/rectal prolapse following the routine preoperative therapeutic and diagnostic protocol and who are indicated for the STARR-procedure.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

previous rectal operation during the last 12 months

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Institut für Neuropathologie
    • Mr.  Prof. Dr. med.  Werner  Paulus 
    • Domagkstr.19
    • 48149  Münster
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/11/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.