FOAM: Functional Outcome After Ventral Mesh Rectopexy

Официальное название

FOAM: Functional Outcome After Ventral Mesh Rectopexy, Prospective Cohort Study

Обзор

Rectal prolapse is a protrusion of rectal wall through the anus. A surgical technique called Ventral mesh rectopexy has become a standard procedure for this condition in many centers. The goal of this trial is to investigate functional outcome, recurrence rates and complications after ventral mesh rectopexy. The main question it aims to answer is: \- Do bowel function, quality of life and sexual function improve after Ventral mesh rectopexy? Participants will: * be asked to fill in questionaires before surgery, 3-6 months after surgery and 12 months after surgery. * be examined by a surgeon 3-6 months, 12 months and 3 years after surgery.

Подробное описание

Several different procedures have been described for surgical treatment of rectal prolapse and a consensus has not yet been reached. Over the past 20 years, the use of Ventral mesh rectopexy to treat external rectal prolapse has gained increasing worldwide acceptance. Ventral mesh rectopexy has become a standard procedure in many centers based on low recurrence rates, limited complications and good functional results but the use and type of mesh have been debated. Concerns have also been expressed regarding the choice of surgical technique, which differs between centers, and the lack of high-level evidence.

There are few prospective trials and the use of LVMR in a Swedish setting has not yet been evaluated. FOAM (Functional Outcome After ventral Mesh rectopexy) therefore aims to investigate bowel function, quality of life, sexual function, recurrence rates and complications after ventral mesh rectopexy.

A prospective cohort study on patients undergoing ventral mesh rectopexy for external rectal prolapse in Sweden will be conducted. Approximately 70 patients will be included at a maximum of 10 hospitals in Sweden.

Вмешательства

• Процедура Ventral mesh rectopexy
  Ventral mesh rectopexy is performed with a superficial peritoneal incision from the right side of the sacral promontory, extended over the right outer border of the mesorectum, towards the deepest part of pouch of Douglas, sparing the right hypogastric nerve. In women, the vagina is retracted anteriorly and a dissection of the rectovaginal septum is performed down to the pelvic floor. A strip of mesh is attached to the ventral part of distal rectum and then fixed upon the sacral promontory.

Первичные конечные точки

• Bowel function [Срок оценки: Evaluated at baseline, 3-6 months and 12 months postoperatively]
• Bowel function [Срок оценки: Evaluated at baseline, 3-6 months and 12 months postoperatively]
• Bowel function [Срок оценки: Evaluated at baseline, 3-6 months and 12 months postoperatively]
• Quality of Life after surgery [Срок оценки: Evaluated at baseline, 3-6 months and 12 months postoperatively]
• Sexual function [Срок оценки: Evaluated at baseline, 3-6 months and 12 months postoperatively]

Вторичные конечные точки (5)

• Recurrence rate [Срок оценки: Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively. Clinical examination by surgeon will be performed to evaluate recurrence.]
• Postoperative complications [Срок оценки: Within 30 days postoperatively]
• Long-term complications [Срок оценки: Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively.]
• Length of stay [Срок оценки: From day of operation to day of discharge from hospital, reported at follow-up 3-6 months postoperatively.]
• Mortality [Срок оценки: Within 30 days postoperatively]

Критерии участия

Критерии включения

• full-thickness rectal prolapse
• the surgeon agrees that ventral mesh rectopexy is needed for the condition
• capable of participating in follow-up visits and answering questionnaires
• informed consent

Критерии исключения

• patient below 18 years of age
• ongoing pregnancy
• inability to understand the Swedish language
• dementia or other cognitive disorder that unables informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Tou S, Brown SR, Nelson RL. Surgery for complete (full-thickness) rectal prolapse in adults. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD001758. doi: 10.1002/14651858.CD001758.pub3. PMID 26599079
• D'Hoore A, Cadoni R, Penninckx F. Long-term outcome of laparoscopic ventral rectopexy for total rectal prolapse. Br J Surg. 2004 Nov;91(11):1500-5. doi: 10.1002/bjs.4779. PMID 15499644
• Badrek-Al Amoudi AH, Greenslade GL, Dixon AR. How to deal with complications after laparoscopic ventral mesh rectopexy: lessons learnt from a tertiary referral centre. Colorectal Dis. 2013 Jun;15(6):707-12. doi: 10.1111/codi.12164. PMID 23384148
• Evans C, Stevenson AR, Sileri P, Mercer-Jones MA, Dixon AR, Cunningham C, Jones OM, Lindsey I. A Multicenter Collaboration to Assess the Safety of Laparoscopic Ventral Rectopexy. Dis Colon Rectum. 2015 Aug;58(8):799-807. doi: 10.1097/DCR.0000000000000402. PMID 26163960
• Randall J, Smyth E, McCarthy K, Dixon AR. Outcome of laparoscopic ventral mesh rectopexy for external rectal prolapse. Colorectal Dis. 2014 Nov;16(11):914-9. doi: 10.1111/codi.12741. PMID 25110205
• Teleman P, Stenzelius K, Iorizzo L, Jakobsson U. Validation of the Swedish short forms of the Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Acta Obstet Gynecol Scand. 2011 May;90(5):483-7. doi: 10.1111/j.1600-0412.2011.01085.x. PMID 21306343
• Hoven E, Flynn KE, Weinfurt KP, Eriksson LE, Wettergren L. Psychometric evaluation of the Swedish version of the PROMIS Sexual Function and Satisfaction Measures in clinical and nonclinical young adult populations. Sex Med. 2023 Jan 12;11(1):qfac006. doi: 10.1093/sexmed/qfac006. eCollection 2023 Feb. PMID 37007849
• Wexner SD. Further validation of the Wexner Incontinence Score: A note of appreciation and gratitude. Surgery. 2021 Jul;170(1):53-54. doi: 10.1016/j.surg.2021.02.039. Epub 2021 Apr 15. No abstract available. PMID 33863582

Идентификаторы

NCT: NCT06455501 · FOAM-trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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