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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00010207 |
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Date of registration:
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22/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of laparoscopic resection rectopexy on urinary symptoms in female patients
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Scientific title:
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Effects of laparoscopic resection rectopexy on urinary symptoms in female patients - n.a. |
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Date of first enrolment:
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01/04/2016 |
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Target sample size:
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100 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00010207 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: Prognosis
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Matthias
Kraemer |
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Address:
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Am Heessener Wald 1
59073
Hamm
Germany |
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Telephone:
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+49-2381-6811401 |
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Email:
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mkraemer@barbaraklinik.de |
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Affiliation:
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Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm |
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Name:
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Matthias
Kraemer |
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Address:
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Am Heessener Wald 1
59073
Hamm
Germany |
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Telephone:
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+49-2381-6811401 |
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Email:
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mkraemer@barbaraklinik.de |
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Affiliation:
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Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm |
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Key inclusion & exclusion criteria
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Inclusion criteria: Female patients who are indicated for laparoscopic resection rectopexy
informed consent
age 18 or older
Exclusion criteria: no consent to participate in the study
patients younger than 18 years
Age minimum:
18 Years
Age maximum:
None
Gender:
Female
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Health Condition(s) or Problem(s) studied
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K62.3
N39.48
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Rectal prolapse
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K62.3
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N39.48
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Intervention(s)
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Group 1: 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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Primary Outcome(s)
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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(s)
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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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Source(s) of Monetary Support
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Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik Hamm
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Ethics review
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Status: Approved
Approval date: 14/08/2015
Contact:
ethik-kommission@aekwl.de
Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster
+49-251-9292460
ethik-kommission@aekwl.de
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