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This study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovarian cancer | Tumor involving rectosigmoid colon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytoreductive surgery | Procedure | Cytoreductive surgery including resection of tumors involving rectosigmoid colon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of major LARS after surgery | Frequency of major LARS (corresponding to 30-42 points as a result of LARS questionnaire) 12 months after LAR implementation | 12 months after LAR implementation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major, minor LARS after visceral peritoneal stripping | Incidence of major, minor LARS after visceral peritoneal stripping, not LAR | 2weeks after surgery |
| LARS severity | LARS severity of before and after surgery(before adjuvant chemotherapy) |
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Inclusion Criteria:
Exclusion Criteria:
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According to the existing literature report, 37.9% to 43.3% of cases of low anterior resection are expected to occur.
Therefore, assuming that the major LARS incidence rate is 40%, and the number of subjects to estimate the incidence rate estimation precision (half of the 95% confidence interval width) within 10% is 93 patients. Considering the loss or death rate of 13.2% during follow-up within 1 year in our hospital, the number of subjects required is 108.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Jin Park, MD | Contact | +82-02-2072-2388 | soojin.mdpark@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hee Seung Kim, MD/PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16394043 | Background | 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. | |
| 11870167 | Background | 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. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000094123 | Low Anterior Resection Syndrome |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D065426 | Cytoreduction Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| 2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery |
| The fecal incontinency quality of life scale(FIQL) | FIQL of before and after surgery | 2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery |
| Bristol stool form scale | Bristol stool form scale of before and after surgery | 2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery |
| EORTC QLQ-Ov28 | EORTC QLQ-Ov28 of before and after surgery | 2weeks before surgery, 6,12,24 months after surgery |
| EOTC QLQ-C30 | EOTC QLQ-C30 of before and after surgery | 2weeks before surgery, 6,12,24 months after surgery |
| 22366151 | Background | 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. |
| 25677122 | Background | 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. |
| 26340884 | Background | 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. |
| 28682965 | Background | 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. |
| 12826043 | Background | 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: 10.1016/s0959-8049(03)00307-1. |
| 32304899 | Background | 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. |
| 32054239 | Background | Kim CW, Jeong WK, Son GM, Kim IY, Park JW, Jeong SY, Park KJ, Lee SH. Validation of Korean Version of Low Anterior Resection Syndrome Score Questionnaire. Ann Coloproctol. 2020 Apr;36(2):83-87. doi: 10.3393/ac.2019.08.01. Epub 2020 Feb 11. |
| 33574345 | Background | Kim MJ, Park JW, Lee MA, Lim HK, Kwon YH, Ryoo SB, Park KJ, Jeong SY. Two dominant patterns of low anterior resection syndrome and their effects on patients' quality of life. Sci Rep. 2021 Feb 11;11(1):3538. doi: 10.1038/s41598-021-82149-9. |
| 31235241 | Background | Kranawetter M, Ataseven B, Grimm C, Schneider S, Riss S, Alesina P, Prader S, Walz MK, Harpain F, Stift A, Heitz F, Reinthaller A, Polterauer S, Harter P, du Bois A. Low anterior resection syndrome (LARS) in patients with epithelial ovarian cancer after primary debulking surgery. Gynecol Oncol. 2019 Sep;154(3):577-582. doi: 10.1016/j.ygyno.2019.06.015. Epub 2019 Jun 21. |
| 33968784 | Background | Park SJ, Mun J, Lee EJ, Park S, Kim SY, Lim W, Song G, Kim JW, Lee S, Kim HS. Clinical Phenotypes of Tumors Invading the Rectosigmoid Colon Affecting the Extent of Debulking Surgery and Survival in Advanced Ovarian Cancer. Front Oncol. 2021 Apr 22;11:673631. doi: 10.3389/fonc.2021.673631. eCollection 2021. |
| 10613469 | Background | Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the fecal incontinence severity index. Dis Colon Rectum. 1999 Dec;42(12):1525-32. doi: 10.1007/BF02236199. |
| 10813117 | Background | Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236. |
| 10521063 | Background | Shimada M, Kigawa J, Minagawa Y, Irie T, Takahashi M, Terakawa N. Significance of cytoreductive surgery including bowel resection for patients with advanced ovarian cancer. Am J Clin Oncol. 1999 Oct;22(5):481-4. doi: 10.1097/00000421-199910000-00012. |
| 30846223 | Background | Son JH, Kim J, Shim J, Kong TW, Paek J, Chang SJ, Ryu HS. Comparison of posterior rectal dissection techniques during rectosigmoid colon resection as part of cytoreductive surgery in patients with epithelial ovarian cancer: Close rectal dissection versus total mesorectal excision. Gynecol Oncol. 2019 May;153(2):362-367. doi: 10.1016/j.ygyno.2019.02.029. Epub 2019 Mar 4. |
| 15129896 | Background | Yun YH, Park YS, Lee ES, Bang SM, Heo DS, Park SY, You CH, West K. Validation of the Korean version of the EORTC QLQ-C30. Qual Life Res. 2004 May;13(4):863-8. doi: 10.1023/B:QURE.0000021692.81214.70. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |