Trial document




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  DRKS00010207

Trial Description

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Title

Effects of laparoscopic resection rectopexy on urinary symptoms in female patients

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Trial Acronym

n.a.

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Laparoscopic resection rectopexy is an established procedure for the repair rectal prolapse. Following this operation, some patients may notice a change of their bladder function. Of these, most will be noticing an improvement. However, in rare instances, a deterioration of bladder function or new urinary symptoms may also be noted. Both potential effects are well recognized. However, so far they have been only insufficiently recorded and quantified in the medical literature. This study therefore aims at clarifying the incidence of positive and negative effects of laparoscopic resection rectopexy on urinary symptoms in female patients.

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Brief Summary in Scientific Language

Rectal prolapse is a functionally important partial aspect of a structural pelvic floor and pelvic organ degeneration mainly due to a progressive and acquired connective tissue and musculo-ligamentous weakness. These changes are commonly summarised as “pelvic floor insufficiency”. Within this degenerative process the bladder commonly also descends caudally particularly in women. The anatomic dislocation of the bladder commonly causes functional problems. In addition to their bowel related problems caused by the rectal prolapse many female patients therefore also report urinary symptoms such as voiding problems and incontinence. Conversely, a detailed interview of female patients seeking therapy for their functional bladder disorders commonly reveals concomitant symptoms of obstructed defaecation or anal incontinence (1,2). The recognition that morphological changes and functional deficits of pelvic floor insufficiency are usually not limited to just one organ entity is the rationale behind interdisciplinary pelvic floor centers which meanwhile have been established in many parts (3-5).

Laparoscopic resection rectopexy is a widely accepted operative treatment of rectal prolapse (6-9). The principles of this operation are the complete mobilization of the rectum down to the pelvic floor. In addition, the pendent sigmoid colon is resected, as to elevate and straighten the entire left sided colorectum up towards the left colonic flexure without any significant residual looping. As a side effect of this procedure the straightening of the mobilized rectum also elevates the ventral compartment including the bladder at least partially, thereby correcting the pre-existing descend. Accordingly, some patient report improved urinary voiding and continence. On the other hand, the operative trauma of the deep mobilization of the rectum may cause temporary or permanent nervous damage of bladder function. So far, both potential effects of laparoscopic rectopexy are only captured not systematically but mostly sporadically.

Literature:

1. Ellington D, Mann M, Bowling C, Drelichman E, Greer W, Szychowski J, Richter H. Pelvic floor symptoms and quality of life analyses in women undergoing surgery for rectal prolapse. World J Colorectal Surg. 2013;3:1-10
2. Pironi D, Pontone S, Podzemny V, Panarese A, Vendettuoli M, Mascagni D, Filippini A. Combined Burch urethropexy and anterior rectopexy in pelvic organ prolapse: skip the mesh. Langenbecks Arch Surg. 2012;397:1157-65
3. Caraballo R, Bologna RA, Lukban J, Whitmore KE. Sacral nerve stimulation as a treatment for urge incontinence and associated pelvic floor disorders at a pelvic floor center: a follow-up study. Urology. 2001;57(6 Suppl 1):121
4. Iachetta RP, Cola A, Villani RD. Sacral nerve stimulation in the treatment of fecal incontinence - the experience of a pelvic floor center : short term results. J Interv Gastroenterol. 2012;2:189-192
5. Kapoor DS, Sultan AH, Thakar R, Abulafi MA, Swift RI, Ness W. Management of complex pelvic floor disorders in a multidisciplinary pelvic floor clinic. Colorectal Dis. 2008;10:118-23
6. Foppa C, Martinek L, Arnaud JP, Bergamaschi R. Ten-year follow up after laparoscopic suture rectopexy for full-thickness rectal prolapse. Colorectal Dis. 2014;16:809-14
7. Johnson E, Stangeland A, Johannessen HO, Carlsen E. Resection rectopexy for external rectal prolapse reduces constipation and anal incontinence. Scand J Surg. 2007;96:56-61
8. Kim M, Reibetanz J, Boenicke L, Germer CT, Jayne D, Isbert C. Quality of life after laparoscopic resection rectopexy. Int J Colorectal Dis. 2012;27:489-95
9. Laubert T, Kleemann M, Roblick UJ, Bürk C, Hildebrand P, Lewejohann J, Schlöricke E, Bruch HP. Obstructive defecation syndrome: 19 years of experience with laparoscopic resection rectopexy. Tech Coloproctol. 2013;17:307-14

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Organizational Data

  •   DRKS00010207
  •   2016/03/22
  •   [---]*
  •   yes
  •   Approved
  •   2015-327-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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

  •   K62.3 -  Rectal prolapse
  •   N39.48 -  [generalization N39.4: Other specified urinary incontinence]
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Interventions/Observational Groups

  •   Included are female patients who are indicated for laparoscopic resection rectopexy.

    Patients are recruited via the coloproctological outpatient clinic run by the department. All patients consulting this clinic receive the ICIQ questionnaire (1) as part of the diagnostic routine. Also within the framework of the usual preoperative assessment patients indicated for laparoscopic resection rectopexy also have a sonographic measuring of residual urine. The study therefore does not change the usual preoperative routine. A control examination is also routinely scheduled at a six weeks postoperatively. For the purpose of this study patients are asked at the 6-week postoperative control visit to again fill in the ICIQ-questionnaire as well as a customized study questionnaire and to undergo a repeat ultrasound assessment of residual urine.

    Literature:
    1. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence.Neurourol Urodyn. 2004;23:322-30
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Rate of subjectively noticed changes of urinary symptoms (positive and/or negative) before and after lapsroscopic resection rectopexy

The rates will be assessed by comparison of pre- and 6-week postoperative assessment of ICIQ-questionnaires, customized study questionnaire, sonsographic assessment of residual urine.

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Secondary Outcome

Objective rate of change of residual urine (positive and /or negative) as assessed by ultrasound before and after resection rectopexy
Pre- and postoperative correlation of subjective urinary symptom perception with objective assessment of residual urine

The rates will be assessed by comparison of pre- and 6-week postoperative assessment of ICIQ-questionnaires, customized study questionnaire, sonsographic assessment of residual urine.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2016/04/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Female patients who are indicated for laparoscopic resection rectopexy
informed consent
age 18 or older

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Exclusion Criteria

no consent to participate in the study
patients younger than 18 years

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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
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    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
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    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
    • Mr.  Priv.-Doz. Dr. med.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.