NCT06082648

Brief Summary

To investigate the effects of intersphincteric resection (ISR) of ultra-low rectal tumor on the brain-rectoanal function of patients, and to precisely localize the cerebral functional regulatory regions for intervention targets of anorectal remodeling. Utilizing transcranial magnetic stimulation(TMS) technology to explore the functional remodeling of the "new" anorectal muscle groups and provide a theoretical basis for more research on the rehabilitation and mechanism of fecal incontinence.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Jun 2023Oct 2026

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Expected
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

September 27, 2023

Last Update Submit

October 7, 2023

Conditions

Rectal Neoplasms

Keywords

Ultra-low rectal tumorsIntersphincteric Resectiontranscranial magnetic stimulationfMRI

Outcome Measures

Primary Outcomes (6)

  • The differences of cortical activated areas in task-state fMRI in ISR patients.

    Cortical activated areas in BOLD sequence of patients in different time frame

    pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure.

  • The differences of cortical activated areas in task-state fMRI between health volunteers and postoperative ISR patients.

    Cortical activated areas in BOLD sequence of health volunteers and patients

    12 month after ileostomy closure。

  • Rectal function scores (Wexner score)

    Wexner score of patients in different time frame

    pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.

  • Rectal function scores (LARS score)

    LARS score of patients in different time frame

    pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.

  • Quality of life Scale (EORTC QLQ-C30)

    EORTC QLQ-C30 of patients in different time frame

    pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.

  • Quality of life Scale (EORTC QLQ-CR38)

    EORTC QLQ-CR38 of patients in different time frame

    pre-ISR，1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.

Secondary Outcomes (1)

  • Proctoanal manometry

    pre-ISR，3 , 6, 12, 18, 24 month after ileostomy closure.

Study Arms (3)

Sham Stimultion Group

SHAM COMPARATOR

Patients on the Sham stimulation group will be interfered with the stimulation coil perpendicular to the skull, so that they will hear the sound of machine without having therapeutic effects. The parameters will be the same as those in the stimulation group.

Device: Sham Transcranial magnetic stimulationt

Pre-ileostomy-closure Stimultion Group

ACTIVE COMPARATOR

Patients on the Pre-ileostomy-closure group will be interfered with stimulation 3 weeks before the procedure of ileostomy closure.

Device: Transcranial magnetic stimulation

Post-ileostomy-closure Stimultion Group

ACTIVE COMPARATOR

Patients on the Post-ileostomy-closure group will be interfered with stimulation 3 weeks after the procedure of ileostomy closure.

Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulationDEVICE

The magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla.Stimulation group: Intermittentpulse transcranial magnetic stimulation (iTBS) will be performed with : the cluster consists of 3 pulses, the intra-cluster frequency is 50Hz, the intercluster frequency is 5Hz, the interval is 8.2s for every stimulus. There are 20 cycles and a total of 600 pulses. Each intervention time is 3min11s, and the stimulation intensity is set as 80% resting state motion threshold. The intervention will be performed once a day for 2 weeks.

Post-ileostomy-closure Stimultion GroupPre-ileostomy-closure Stimultion Group
Sham Transcranial magnetic stimulationtDEVICE

The magnetic stimulator equipment is provided by the MagProX100 magnetic stimulator ( MagVenture, Lucernemarken, DK-3520 Farum, Denmark), with 8-shaped coil, a maximum stimulation frequency of 30Hz and a maximum stimulation intensity of 6 Tesla. Patients on the Sham stimulation group will be interfered with the stimulation coil perpendicular to the skull, so that they will hear the sound of machine without having therapeutic effects. The parameters will be the same as those in the stimulation group.

Sham Stimultion Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary ultra-low rectal tumor patient who is received intersphincteric resection and preventive ileostomy was performed.
  • Patient who is willing to participate in the study, and voluntarily sign informed consent.

You may not qualify if:

  • Anastomotic leakage or other serious complications occur after surgery.
  • Advanced tumor, tumor recurrence or metastasis.
  • Patients with contraindications of fMRI scanning, such as history of metal implants in the body, claustrophobia, etc.
  • Patients with contraindications for TMS treatment, such as intracranial metal implants, epilepsy history, heart disease with unstable heart function, retinal detachment, etc.
  • Combined with organic brain disease and drug abuse history.
  • Combined with other mental diseases.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Jianbin Xiang, PhD

    Huashan Hospital

    STUDY CHAIR

Central Study Contacts

Ying Mao, PhD

CONTACT

8621-52889999Maoying@huashan.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor，Ph.D., M.D.

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 13, 2023

Study Start

June 1, 2023

Primary Completion

October 30, 2024

Study Completion (Estimated)

October 30, 2026

Last Updated

October 13, 2023

Record last verified: 2023-10

Locations

CN(1)