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Rectal NeoplasmsNCT06082648

Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors

A study testing Transcranial magnetic stimulation in people with Rectal Neoplasms, run by Huashan Hospital at 1 site in China.

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

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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Rectal Neoplasms
What is being tested?
Transcranial magnetic stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
1 siteChina
Study dates
1 Jun 2023to 30 Oct 2026
Phase
Interventional
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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

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

Ying Mao, PhD contact

8621-52889999

Maoying@huashan.cn

China1 site, 1 recruiting

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, 200040

    Jianbin Xiang, doctor, 86-21-52887040, 68875417@qq.com

    Minwei Zhou, doctor, 86-21-52887040, zmwf1@126.com

    Recruiting

Other trials in China

About this study

Official title: Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors

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.

Read the detailed description

This study is a Single-center Phase II, Open, Three-Arm clinical trial. We prospectively enroll patients who undergo ISR for ultra-low rectal tumor in the department of General Surgery, Huashan Hospital, Fudan University. Patients with ileostomy closure are randomly divided into two groups (TMS group and false stimulation group), and healthy volunteers were recruited. The differences of task-state fMRI between healthy volunteers, and ISR patients (both preoperative and postoperative) are compared, combined with rectal function scores (Wexner score, LARS score) and quality of life scale (EORTC QLQ-C30, EORTC QLQ-CR38). Proctoanal manometry are used to find the precise location of the proctoanal motor function area in the cerebral cortex, and to evaluate the effect and value of TMS on postoperative anorectal motor function remodeling in patients with ISR.

Being tested
Transcranial magnetic stimulation, Sham Transcranial magnetic stimulationt
Keywords
Ultra-low rectal tumors, Intersphincteric Resection, transcranial magnetic stimulation, fMRI
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • 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.

  • 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.

Study groups in NCT06082648
Study groupRoleWhat they receive
Sham Stimultion GroupSham comparatorPatients 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.
Receives: Device: Sham Transcranial magnetic stimulationt
Pre-ileostomy-closure Stimultion GroupActive comparatorPatients on the Pre-ileostomy-closure group will be interfered with stimulation 3 weeks before the procedure of ileostomy closure.
Receives: Device: Transcranial magnetic stimulation
Post-ileostomy-closure Stimultion GroupActive comparatorPatients on the Post-ileostomy-closure group will be interfered with stimulation 3 weeks after the procedure of ileostomy closure.
Receives: Device: Transcranial magnetic stimulation

What is being measured

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

  1. 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

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

  2. 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

    Measured: 12 month after ileostomy closure。

  3. Rectal function scores (Wexner score)

    Wexner score of patients in different time frame

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

  4. Rectal function scores (LARS score)

    LARS score of patients in different time frame

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

  5. Quality of life Scale (EORTC QLQ-C30)

    EORTC QLQ-C30 of patients in different time frame

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

  6. Quality of life Scale (EORTC QLQ-CR38)

    EORTC QLQ-CR38 of patients in different time frame

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

Secondary outcomes (1)

  1. Proctoanal manometry

    Proctoanal manometry of Patients in different time frame

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

Timeline

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

  1. First posted13 Oct 2023
  2. Study start1 Jun 2023
  3. Primary completion30 Oct 2024 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06082648
Sponsor's protocol ID
KY2023-087
Status last verified
Oct 2023
First submitted
27 Sep 2023
Last updated
13 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial magnetic stimulation in people with Rectal Neoplasms, run by Huashan Hospital at 1 site in China.

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 2 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 13 Oct 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 China. 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. Some participants in this study may receive a placebo. 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 Ying Mao, PhD (8621-52889999, Maoying@huashan.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The differences of cortical activated areas in task-state fMRI in ISR patients. (time frame: pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure.). The study lists 6 primary outcomes in all. 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 NCT06082648.

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 13 Oct 2023.

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