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

Primary Purpose

Rectal Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sham Transcranial magnetic stimulationt
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring Ultra-low rectal tumors, Intersphincteric Resection, transcranial magnetic stimulation, fMRI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Huashan Hospital Affiliated to Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Sham Stimultion Group

Pre-ileostomy-closure Stimultion Group

Post-ileostomy-closure Stimultion Group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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
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
Rectal function scores (Wexner score)
Wexner score of patients in different time frame
Rectal function scores (LARS score)
LARS score of patients in different time frame
Quality of life Scale (EORTC QLQ-C30)
EORTC QLQ-C30 of patients in different time frame
Quality of life Scale (EORTC QLQ-CR38)
EORTC QLQ-CR38 of patients in different time frame

Secondary Outcome Measures

Proctoanal manometry
Proctoanal manometry of Patients in different time frame

Full Information

First Posted
September 27, 2023
Last Updated
October 7, 2023
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06082648
Brief Title
Study of Brain-Gut Function Reconstruction After Intersphincteric Resection for Ultra-Low Rectal Tumors
Official Title
Observation and Intervention Study of Brain-Gut Function Reconstruction After Intersphincteric Resection (ISR) for Ultra-Low Rectal Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
Ultra-low rectal tumors, Intersphincteric Resection, transcranial magnetic stimulation, fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham Stimultion Group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Pre-ileostomy-closure Stimultion Group
Arm Type
Active Comparator
Arm Description
Patients on the Pre-ileostomy-closure group will be interfered with stimulation 3 weeks before the procedure of ileostomy closure.
Arm Title
Post-ileostomy-closure Stimultion Group
Arm Type
Active Comparator
Arm Description
Patients on the Post-ileostomy-closure group will be interfered with stimulation 3 weeks after the procedure of ileostomy closure.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial magnetic stimulationt
Intervention Description
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.
Primary Outcome Measure Information:
Title
The differences of cortical activated areas in task-state fMRI in ISR patients.
Description
Cortical activated areas in BOLD sequence of patients in different time frame
Time Frame
pre-ISR, pre-ileostomy closure, 6,12 month after ileostomy closure.
Title
The differences of cortical activated areas in task-state fMRI between health volunteers and postoperative ISR patients.
Description
Cortical activated areas in BOLD sequence of health volunteers and patients
Time Frame
12 month after ileostomy closure。
Title
Rectal function scores (Wexner score)
Description
Wexner score of patients in different time frame
Time Frame
pre-ISR,1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
Title
Rectal function scores (LARS score)
Description
LARS score of patients in different time frame
Time Frame
pre-ISR,1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
Title
Quality of life Scale (EORTC QLQ-C30)
Description
EORTC QLQ-C30 of patients in different time frame
Time Frame
pre-ISR,1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
Title
Quality of life Scale (EORTC QLQ-CR38)
Description
EORTC QLQ-CR38 of patients in different time frame
Time Frame
pre-ISR,1, 3 , 6, 9, 12, 18, 24 month after ileostomy closure.
Secondary Outcome Measure Information:
Title
Proctoanal manometry
Description
Proctoanal manometry of Patients in different time frame
Time Frame
pre-ISR,3 , 6, 12, 18, 24 month after ileostomy closure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Mao, PhD
Phone
8621-52889999
Email
Maoying@huashan.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianbin Xiang, PhD
Organizational Affiliation
Huashan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianbin Xiang, doctor
Phone
86-21-52887040
Email
68875417@qq.com
First Name & Middle Initial & Last Name & Degree
Minwei Zhou, doctor
Phone
86-21-52887040
Email
zmwf1@126.com
First Name & Middle Initial & Last Name & Degree
Jianbin Xiang, doctor

12. IPD Sharing Statement

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

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