Effects of laparoscopic resection rectopexy on urinary symptoms in female patients
Organizational Data
- DRKS-ID:
- DRKS00010207
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2016-03-22
- Last update in DRKS:
- 2022-07-18
- Registration type:
- Prospective
Acronym/abbreviation of the study
n.a.
URL of the study
No Entry
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.
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
Health condition or problem studied
- ICD10:
- K62.3 - Rectal prolapse
- ICD10:
- N39.48
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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
Endpoints
- 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.
- 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.
Study Design
- Purpose:
- Prognosis
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center St. Barbara-Klinik Hamm
Recruitment period and number of participants
- Planned study start date:
- 2016-04-01
- Actual study start date:
- 2016-04-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-08-16
- Target Sample Size:
- 100
- Final Sample Size:
- 100
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik HammPriv.-Doz. Dr. med. Matthias KraemerAm Heessener Wald 159073 HammGermany
- Telephone:
- +49-2381-6811401
- Fax:
- +49-2381-6811168
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.barbaraklinik.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik HammPriv.-Doz. Dr. med. Matthias KraemerAm Heessener Wald 159073 HammGermany
- Telephone:
- +49-2381-6811401
- Fax:
- +49-2381-6811168
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.barbaraklinik.de
Contact for Public Queries
- Address:
- Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik HammPriv.-Doz. Dr. med. Matthias KraemerAm Heessener Wald 159073 HammGermany
- Telephone:
- +49-2381-6811401
- Fax:
- +49-2381-6811168
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.barbaraklinik.de
Principal Investigator
- Address:
- Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik HammPriv.-Doz. Dr. med. Matthias KraemerAm Heessener Wald 159073 HammGermany
- Telephone:
- +49-2381-6811401
- Fax:
- +49-2381-6811168
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.barbaraklinik.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Abteilung Allgemein- und Viszeralchirurgie, KoloproktologieSt. Barbara-Klinik HammAm Heessener Wald 159073 HammGermany
- Telephone:
- +49-2381-6811401
- Fax:
- +49-2381-6811168
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.barbaraklinik.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität MünsterGartenstraße 210-21448147 MünsterGermany
- Telephone:
- +49-251-9292460
- Fax:
- +49-251-9292478
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-06-23
- Ethics committee number:
- 2015-327-f-S
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-08-14
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Laparoscopic resection rectopexy significantly affects preexisting urinary symptoms in female patients. M. Kraemer, S. Kraemer, C. Ceran C Int J Colorectal Dis 2022; 37:1301-07
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry