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A prospective observational study of preoperative bio-feedback therapy to prevent Low Anterior Resection Syndrome (LARS) following rectal surgery

A prospective observational study of preoperative bio-feedback therapy to prevent Low Anterior Resection Syndrome (LARS) following rectal surgery - A prospective observational study of preoperative bio-feedback therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000046527
Enrollment
100
Registered
2022-01-05
Start date
2021-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

None listed

Sponsors

Department of Surgery, Surgical Oncology, Sapporo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are scheduled to undergo SPS with temporary ileal fistula for lower rectal cancer and meet the following conditions 1) Have undergone preoperative BFR 2) Patient who is able to continue rehabilitation at home. (3) Patient who is able to continue outpatient visits after surgery 4) Written consent for participation has been obtained.

Exclusion criteria

Exclusion criteria: In case the doctor considered the patient inappropriate to attempt the study.

Design outcomes

Primary

MeasureTime frame
Incidence of severe LARS six months after ileal stoma closure

Secondary

MeasureTime frame
Anal pressure, State of fecal disorder (LARS score, Wexner score), State of QoL (mFIQL, SF36)

Countries

Japan

Contacts

Public ContactEmi Akizuki

Sapporo Medical University Department of Surgery, Surgical Oncology

akizuki@sapmed.ac.jp011-611-2111(32810)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026