Fecal Incontinence Clinical Trial
Official title:
Evaluation of Anatomy and Symptoms After Surgery With a Novel Anterior Rectopexy in a Cohort With Combined Pelvic Defects.
Verified date | April 2024 |
Source | Sahlgrenska University Hospital, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Several pelvic prolapses can render defecation difficulties and they are often treated with different surgical techniques. This study will evaluate a novel variation of a laparoscopic technique used to treat rectal prolapse that is modified to treat multiple pelvic prolapses. 25 women with symptoms of obstructed defecation and multiple pelvic prolapses are assessed before and after surgery with clinical examination, defecography and a questionnaire for bowel function and quality of life. Follow up was scheduled after three and twelve months and at long term (minimum ten years).
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | April 1, 2025 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Symptoms of obstructed defecation, more than one posterior pelvic organ prolapse, undergone conservative treatment Exclusion Criteria: - Anismus |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Sahlgrenska University Hospital, Sweden |
Boons P, Collinson R, Cunningham C, Lindsey I. Laparoscopic ventral rectopexy for external rectal prolapse improves constipation and avoids de novo constipation. Colorectal Dis. 2010 Jun;12(6):526-32. doi: 10.1111/j.1463-1318.2009.01859.x. Epub 2009 Apr 10. — View Citation
D'Hoore A, Penninckx F. Laparoscopic ventral recto(colpo)pexy for rectal prolapse: surgical technique and outcome for 109 patients. Surg Endosc. 2006 Dec;20(12):1919-23. doi: 10.1007/s00464-005-0485-y. — View Citation
Mellgren A, Bremmer S, Johansson C, Dolk A, Uden R, Ahlback SO, Holmstrom B. Defecography. Results of investigations in 2,816 patients. Dis Colon Rectum. 1994 Nov;37(11):1133-41. doi: 10.1007/BF02049817. — View Citation
Mellgren A, Dolk A, Johansson C, Bremmer S, Anzen B, Holmstrom B. Enterocele is correctable using the Ripstein rectopexy. Dis Colon Rectum. 1994 Aug;37(8):800-4. doi: 10.1007/BF02050145. — View Citation
Tsunoda A, Takahashi T, Matsuda S, Kusanagi H. Long-term annual functional outcome after laparoscopic ventral rectopexy for rectoanal intussusception and/or rectocele: evaluation of sustained improvement. Tech Coloproctol. 2021 Dec;25(12):1281-1289. doi: 10.1007/s10151-021-02499-4. Epub 2021 Oct 11. — View Citation
van Geluwe B, Wolthuis A, Penninckx F, D'Hoore A. Lessons learned after more than 400 laparoscopic ventral rectopexies. Acta Chir Belg. 2013 Mar-Apr;113(2):103-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence | Clinical and radiological assesment of relapse of prolapse | One year | |
Primary | Bowel function | Questionnaire regarding fecal incontinence and obstructed defecation | Over ten years | |
Primary | Bowel related quality of life | Questionnaire regarding bowel related quality of life | Over ten years | |
Secondary | Postoperative complications | Complications within 30 days after surgery | 30 days | |
Secondary | Peroperative complications | Complications during surgery | surgery | |
Secondary | Operative time | Time from start of operative procedure to the end of surgery | minutes | |
Secondary | Conversions to open surgery | Numbers of operations where conversion to open surgery were necessary | Numbers | |
Secondary | Hospital days | Number of days in hospital after surgery | days |
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