Slow TransitNCT04525248
Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation
A study testing Laparoscopic total colectomy + low resection of rectum and Laparoscopic total colectomy + High resection of rectum in people with Slow Transit and Constipation, run by Shanghai Minimally Invasive Surgery Center.
Trial summary
Study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Slow Transit, Constipation
- What is being tested?
- Laparoscopic total colectomy + low resection of rectum and Laparoscopic total colectomy + High resection of rectum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed as constipation according to Rome IV criteria
- Diagnosed as slow transit constipation
- With more than 2 years' drug treatment or with outlet obstruction or with surgical history
Who cannot join
- Colon cancer
- History of colon, rectum, anus surgery
- With severe cardio, renal, neural disease
- Pregnant patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: High Resection vs. Low Resection of Rectum in Laparoscopic Total Colectomy for Slow Transit Constipation
Study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum
Read the detailed description
The investigators are going to study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum. High resection is defined as resection at 12~15cm from anus and low resection as 6~8cm.
- Conditions
- Slow Transit, Constipation
- Being tested
- Laparoscopic total colectomy + low resection of rectum, Laparoscopic total colectomy + High resection of rectum
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic total colectomy + low resection of rectumProcedure or surgery
Laparoscopic total colectomy + low resection of rectum
Laparoscopic total colectomy + High resection of rectumProcedure or surgery
Laparoscopic total colectomy + High resection of rectum
| Study group | Role | What they receive |
|---|---|---|
| High resection | Active comparator | Laparoscopic total colectomy + High resection of rectum Receives: Procedure: Laparoscopic total colectomy + High resection of rectum |
| Low resection | Experimental | Laparoscopic total colectomy + Low resection of rectum Receives: Procedure: Laparoscopic total colectomy + low resection of rectum |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence rate of constipation
1-year recurrence rate of constipation
Measured: 1 year
Secondary outcomes (2)
1-year rate of diarrhea
1-year rate of diarrhea
Measured: 1 year
perioperative complications
perioperative complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Slow TransitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minhua Zheng, Study chair, Shanghai MISC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525248
- Sponsor's protocol ID
- MISC-Constipation-Rectum
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resection vs. Low Resection of Rectum in Laparoscopic Total Colectomy for Slow Transit Constipation
- ClinicalTrials.gov ID
- NCT04525248
- Acronym / sponsor ID
- MISC-Constipation-Rectum
- Conditions
- Slow Transit, Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum
Detailed description
The investigators are going to study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum. High resection is defined as resection at 12~15cm from anus and low resection as 6~8cm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High resection | Active comparator | Procedure: Laparoscopic total colectomy + High resection of rectumLaparoscopic total colectomy + High resection of rectum |
| Low resection | Experimental | Procedure: Laparoscopic total colectomy + low resection of rectumLaparoscopic total colectomy + Low resection of rectum |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as constipation according to Rome IV criteria
- Diagnosed as slow transit constipation
- With more than 2 years' drug treatment or with outlet obstruction or with surgical history
Key exclusion criteria (4 listed)
- Colon cancer
- History of colon, rectum, anus surgery
- With severe cardio, renal, neural disease
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic total colectomy + low resection of rectumLaparoscopic total colectomy + low resection of rectum | Procedure or surgery | Low resection |
| Laparoscopic total colectomy + High resection of rectumLaparoscopic total colectomy + High resection of rectum | Procedure or surgery | High resection |
Primary outcome
1-year recurrence rate of constipation
Time frame: 1 year
1-year recurrence rate of constipation
2 secondary outcomes
1-year rate of diarrhea
Time frame: 1 year
perioperative complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Slow Transit
RecruitingPhase 3
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Slow Transit Constipation, Pharmacotherapy
Active, not recruiting
STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation
Slow Transit Constipation, Surgery
Not yet recruitingObservational study
Preoperative Fish Oil PN and Prognosis After Constipation Surgery
Constipation, Slow Transit Constipation
Recruiting
MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
Chronic Constipation, Slow Transit Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minhua Zheng study chair
Shanghai MISC
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic total colectomy + low resection of rectum and Laparoscopic total colectomy + High resection of rectum in people with Slow Transit and Constipation, run by Shanghai Minimally Invasive Surgery Center.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junjun Ma, Dr (+86 13917283686, marsnew1997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year recurrence rate of constipation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2020.