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Ovarian CancerLAPSODYNCT05431530

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

An observational study of Ovarian Cancer and Low Anterior Resection Syndrome, run by Seoul National University Hospital at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cytoreductive surgery
Type of treatment
Surgery or procedure
How many people
108 participants
Where
1 siteSouth Korea
Study dates
22 Jun 2022to 31 May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Soo Jin Park, MD contact

+82-02-2072-2388

soojin.mdpark@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Soo Jin Park, MD, +82-02-2072-2388, soojin.mdpark@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: 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

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

Read the detailed description

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.

Being tested
Cytoreductive surgery
Medical subject headings
Ovarian Neoplasms, Low Anterior Resection Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cytoreductive surgeryProcedure or surgery

    Cytoreductive surgery including resection of tumors involving rectosigmoid colon.

Study groups in NCT05431530
Study groupRoleWhat they receive
Ovarian cancerTumor involving rectosigmoid colon
Receives: Procedure: Cytoreductive surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months after LAR implementation

Secondary outcomes (6)

  1. Incidence of major, minor LARS after visceral peritoneal stripping

    Incidence of major, minor LARS after visceral peritoneal stripping, not LAR

    Measured: 2weeks after surgery

  2. LARS severity

    LARS severity of before and after surgery(before adjuvant chemotherapy)

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

  3. The fecal incontinency quality of life scale(FIQL)

    FIQL of before and after surgery

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

  4. Bristol stool form scale

    Bristol stool form scale of before and after surgery

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

  5. EORTC QLQ-Ov28

    EORTC QLQ-Ov28 of before and after surgery

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

  6. EOTC QLQ-C30

    EOTC QLQ-C30 of before and after surgery

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start22 Jun 2022
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431530
Sponsor's protocol ID
LARS-1.0
Acronym
LAPSODY
Status last verified
Jun 2023
First submitted
19 Jun 2022
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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: 10.1016/s0959-8049(03)00307-1.

    PubMed 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.

    PubMed 32304899

  • 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.

    PubMed 32054239

  • 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.

    PubMed 33574345

  • 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.

    PubMed 31235241

  • 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.

    PubMed 33968784

  • 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.

    PubMed 10613469

  • 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.

    PubMed 10813117

  • 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.

    PubMed 10521063

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Cancer and Low Anterior Resection Syndrome, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Soo Jin Park, MD (+82-02-2072-2388, soojin.mdpark@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of major LARS after surgery (time frame: 12 months after LAR implementation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05431530, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.

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