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

NCT05431530 | Recruiting

• 1 other identifier: LARS-1.0
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Cancer; Low Anterior Resection Syndrome; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Incidence of major, minor LARS after visceral peritoneal stripping

  2weeks after surgery

• LARS severity

  2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery

• The fecal incontinency quality of life scale(FIQL)

  2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery

• Bristol stool form scale

  2weeks before surgery, 2weeks after surgery(before adjuvant chemotherapy), 3,6,12,24 months after surgery

• EORTC QLQ-Ov28

  2weeks before surgery, 6,12,24 months after surgery

Study Arms (1)

Ovarian cancer

Tumor involving rectosigmoid colon

Procedure: Cytoreductive surgery

Interventions

Cytoreductive surgery PROCEDURE

Cytoreductive surgery including resection of tumors involving rectosigmoid colon.

Ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (17)

• 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 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.

  PMID: 11870167 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.

  PMID: 22366151 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.

  PMID: 25677122 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.

  PMID: 26340884 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.

  PMID: 28682965 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.

  PMID: 12826043 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.

  PMID: 32304899 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.

  PMID: 32054239 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.

  PMID: 33574345 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.

  PMID: 31235241 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.

  PMID: 33968784 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.

  PMID: 10613469 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.

  PMID: 10813117 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.

  PMID: 10521063 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.

  PMID: 30846223 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.

  PMID: 15129896 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Low Anterior Resection Syndrome

Interventions

Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Hee Seung Kim, MD/PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Jin Park, MD

CONTACT

+82-02-2072-2388; soojin.mdpark@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 24, 2022
• Study Start: June 22, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)