Assessment of Quality of Life After Low Anterior Resection During Cytoreductive Surgery for Advanced Ovarian Cancer

Официальное название

Assessment of Quality of Life After Low Anterior Resection or Visceral Peritoneal Stripping During cytOreDuctive surgerY for Advanced Ovarian Cancer Requiring Tumor Resection on the Rectosigmoid Colon: a Prospective Cohort Study

Обзор

This study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

Подробное описание

In advanced ovarian cancer, 24-64% of patients require removal of tumors located in the rectum and sigmoid colon. In order to remove the tumor located in the rectum and sigmoid colon, low anterior resection (LAR) is performed to excise the rectum and sigmoid colon. All patients who underwent low anterior resection are at risk of developing low anterior resection syndrome, which presents symptoms such as frequent bowel movements, frequent defecation, and impaired stool control. Therefore, this study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

Вмешательства

• Процедура Cytoreductive surgery
  Cytoreductive surgery including resection of tumors involving rectosigmoid colon.

Первичные конечные точки

• Frequency of major LARS after surgery [Срок оценки: 12 months after LAR implementation]

Вторичные конечные точки (6)

• Incidence of major, minor LARS after visceral peritoneal stripping [Срок оценки: 2weeks after surgery]
• LARS severity [Срок оценки: 2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery]
• The fecal incontinency quality of life scale(FIQL) [Срок оценки: 2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery]
• Bristol stool form scale [Срок оценки: 2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery]
• EORTC QLQ-Ov28 [Срок оценки: 2weeks before surgery, 6,12,24 months after surgery]
• EOTC QLQ-C30 [Срок оценки: 2weeks before surgery, 6,12,24 months after surgery]

Критерии участия

Критерии включения

• Those with newly diagnosed ovarian cancer, fallopian tube cancer and primary peritoneal carcinomatosis who plan to undergo cytoreductive surgery and secondary cytoreductive surgery after neoadjuvant chemotherapy.
• Patients with PCDS or rectal and sigmoid coloni tumor invasion suspected on the preoperative image and need resection of the tumor and clinical FIGO stage IIIB or higher
• ECOG performance status : 0-2
• Age over 18

Критерии исключения

• Patient who underwent low anterior resection in the past
• Past history of gastrointestinal malignant tumor except to ovarian cancer
• Patient who have colostomy
• Patient who underwent radiation therapy to abdominal or pelvic cavity
• ECOG performance status over 3
• Patient taking opioid analgesics
• Patient who have intellectual disability or dementia

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Публикации

• Aletti GD, Dowdy SC, Gostout BS, Jones MB, Stanhope CR, Wilson TO, Podratz KC, Cliby WA. Aggressive surgical effort and improved survival in advanced-stage ovarian cancer. Obstet Gynecol. 2006 Jan;107(1):77-85. doi: 10.1097/01.AOG.0000192407.04428.bb. PMID 16394043
• Bristow RE, Tomacruz RS, Armstrong DK, Trimble EL, Montz FJ. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis. J Clin Oncol. 2002 Mar 1;20(5):1248-59. doi: 10.1200/JCO.2002.20.5.1248. PMID 11870167
• Chang SJ, Bristow RE. Evolution of surgical treatment paradigms for advanced-stage ovarian cancer: redefining 'optimal' residual disease. Gynecol Oncol. 2012 May;125(2):483-92. doi: 10.1016/j.ygyno.2012.02.024. Epub 2012 Feb 23. PMID 22366151
• Chen TY, Wiltink LM, Nout RA, Meershoek-Klein Kranenbarg E, Laurberg S, Marijnen CA, van de Velde CJ. Bowel function 14 years after preoperative short-course radiotherapy and total mesorectal excision for rectal cancer: report of a multicenter randomized trial. Clin Colorectal Cancer. 2015 Jun;14(2):106-14. doi: 10.1016/j.clcc.2014.12.007. Epub 2014 Dec 31. PMID 25677122
• Ekkarat P, Boonpipattanapong T, Tantiphlachiva K, Sangkhathat S. Factors determining low anterior resection syndrome after rectal cancer resection: A study in Thai patients. Asian J Surg. 2016 Oct;39(4):225-31. doi: 10.1016/j.asjsur.2015.07.003. Epub 2015 Sep 2. PMID 26340884
• Gadan S, Floodeen H, Lindgren R, Matthiessen P. Does a Defunctioning Stoma Impair Anorectal Function After Low Anterior Resection of the Rectum for Cancer? A 12-Year Follow-up of a Randomized Multicenter Trial. Dis Colon Rectum. 2017 Aug;60(8):800-806. doi: 10.1097/DCR.0000000000000818. PMID 28682965
• Greimel E, Bottomley A, Cull A, Waldenstrom AC, Arraras J, Chauvenet L, Holzner B, Kuljanic K, Lebrec J, D'haese S; EORTC Quality of Life Group and the Quality of Life Unit. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-OV28) in assessing the quality of life of patients with ovarian cancer. Eur J Cancer. 2003 Jul;39(10):1402-8. doi PMID 12826043
• Harpain F, Kranawetter M, Zott T, Lazaridis II, Guenin MO, Ninkovic M, Kronberger IE, Tapiolas I, Basany EE, Dauser B, Herbst F, Koh C, Stift A, Teleky B, Reinthaller A, Grimm C, Riss S. Low anterior resection syndrome (LARS) in ovarian cancer patients - A multi-centre comparative cohort study. Int J Surg. 2020 Jun;78:97-102. doi: 10.1016/j.ijsu.2020.04.019. Epub 2020 Apr 15. PMID 32304899

Идентификаторы

NCT: NCT05431530 · LARS-1.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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