UMIN-CTR Clinical Trial

Public title

LARS, Individual Personality, and Functional Experience after Rectal Cancer Surgery LIFE-1 study

Acronym

LIFE-1 study

Scientific Title

LARS, Individual Personality, and Functional Experience after Rectal Cancer Surgery LIFE-1 study

Scientific Title:Acronym

LIFE-1 study

Region

Japan

Condition

Primary rectal adenocarcinoma or rectal neuroendocrine neoplasm

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to investigate risk factors associated with LARS and impaired QOL after sphincter-preserving surgery for rectal cancer, with a particular focus on clarifying the association of preoperative personality traits with postoperative LARS and QOL.

Basic objectives2

Others

Basic objectives -Others

Exploratory analysis

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

QOL scores at 12 months postoperatively, and their changes from baseline, assessed using the mFIQL and EORTC QLQ-CR29.

Key secondary outcomes

1. Stratified analysis of QOL scores and their changes from baseline according to LARS severity (no LARS, minor LARS, and major LARS).
2. QOL scores at 6 months postoperatively, and their changes from baseline.
3. LARS scores at 6 and 12 months postoperatively, and changes in the scores from 6 to 12 months postoperatively.
4. Associations of anorectal manometry parameters with QOL scores and LARS scores.
5. Associations of combinations of personality traits with QOL scores and LARS scores.
6. Association between preoperative pelvic floor muscle volume and LARS scores at 12 months postoperatively.
7. Associations of anastomotic diameter (stapler size) with QOL scores and LARS scores.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Patients who have been histopathologically diagnosed with primary rectal cancer, including adenocarcinoma or neuroendocrine neoplasm, or patients in whom these diagnoses are strongly suspected.
2. Patients who are scheduled to undergo curative low anterior resection or intersphincteric resection for rectal cancer.

Key exclusion criteria

1. Patients scheduled to undergo treatment for other malignancies between the diagnosis of rectal cancer and admission for surgery.
2. Patients with active multiple primary cancers, including synchronous multiple cancers or metachronous multiple cancers with a disease-free interval of less than 5 years, who are currently receiving or scheduled to receive treatment.
3. Patients with distant metastasis.
4. Patients undergoing emergency surgery.
5. Patients who have already started neoadjuvant treatment for rectal cancer, including chemotherapy, radiotherapy, or total neoadjuvant therapy, before registration.
6. Patients who have undergone stoma creation related to rectal cancer prior to registration.
7. Patients diagnosed with a psychiatric disorder who are receiving treatment, including pharmacotherapy, at the time of registration.
8. Patients deemed inappropriate for participation by the principal investigator or a co-investigator.

Target sample size

160

Name of lead principal investigator

1st name	Kazutaka
Middle name
Last name	Obama

Organization

Kyoto University

Division name

Department of surgery

Zip code

606-507

Address

54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-3111

Email

kobama@kuhp.kyoto-u.ac.jp

Name of contact person

1st name	Takumi
Middle name
Last name	Kozu

Organization

Kyoto University

Division name

Department of surgery

Zip code

606-507

Address

54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto

TEL

075-751-3111

Homepage URL

Email

takumi_kozu@kuhp.kyoto-u.ac.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Public Health Research Foundation

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院（京都府）、京都医療センター（京都府）、大阪赤十字病院（大阪府）、北野病院（大阪府）、神戸市立医療センター中央市民病院（兵庫県）、滋賀県立総合病院（滋賀県）、天理よろづ相談所病院（奈良県）、洛和会音羽病院（京都府）、日本バプテスト病院（京都府）、福岡大学病院（福岡県）、近畿大学病院（大阪府）、宇治徳洲会病院（京都府）

Date of disclosure of the study information

2026

Year

07

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

07

Month

10

Day

Date of IRB

Anticipated trial start date

2026

Year

07

Month

15

Day

Last follow-up date

2028

Year

07

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a multicenter prospective observational study conducted at Kyoto University Hospital and 11 affiliated institutions. Patients aged 18 to 75 years with rectal cancer who are scheduled to undergo sphincter preserving surgery will be eligible for enrollment.
The observation items include clinical information, psychological characteristics, quality of life, and bowel function. Psychological characteristics will be assessed using self administered questionnaires, including the Japanese version of the Ten Item Personality Inventory, TIPI J, and the Japanese version of the Autism Spectrum Quotient, AQ J.
Data will be collected preoperatively and at 6 and 12 months postoperatively. The primary outcomes are the QOL score at 12 months postoperatively and the change from the baseline. The enrollment period will be 1 year, with a target sample size of 160 patients.
This study aims to clarify the associations between preoperative psychological characteristics and the development of LARS and postoperative QOL, and to identify patient groups who may benefit from future individualized support and psychological interventions.

Registered date

2026

Year

07

Month

14

Day

Last modified on

2026

Year

07

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070877