ConstipationPhase 4NCT02147574
Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation
A Phase 4 study testing Anti-peristaltic ileosigmoid anastomosis in people with Constipation, run by Anlong Zhu at 1 site in China.
Trial summary
Purpose: To evaluate the curative effect of Laparoscope Sub-total Colectomy with Anti-peristaltic ileosigmoid anastomosis for the treatment of slow-transit constipation on the patients with STC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation
- What is being tested?
- Anti-peristaltic ileosigmoid anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Apr 2014
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the clinical diagnose of STC
- Severe symptoms of constipation, defecating less than 2 times per week, no awareness of defecation, using laxatives to help defecation or there's no effects of laxatives.
- Symptoms of constipation last at least 2 years, and ineffective effects received from medicine treatment for more than one year.
- Colorectal organic disease was excluded
- More than one colonic transit trials suggest dysfunction of colon transport, no significant intestinal transit dysfunction
Who cannot join
- significant mental disorder
- surgical contraindications
- Can't accept surgery subjectively
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
About this study
Official title: Laparoscope Subtotal Colectomy With Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation
Purpose:
To evaluate the curative effect of Laparoscope Sub-total Colectomy with Anti-peristaltic ileosigmoid anastomosis for the treatment of slow-transit constipation on the patients with STC.
Read more
Methods and techniques:
The data of patients with STC preformed surgery of laparoscopic subtotal colectomy with anti-peristaltic ileosigmoid anastomosis during 2009.01-2014.05 was reviewed. The related status such as frequency of defecation, course of constipation, laxatives use condition the condition of using laxatives, and changes in weight were investigated. Changes of defecation and weight, periprocedural complications (wound infection, lung infection and intestinal fistula), long-term complication (malnutrition, abdominal pain, ileus), life satisfaction, wexner score of pre-operation and postoperation ect were investigated in follow-ups.
Read the detailed description
Theoretical Basis:
As far as the current research status, total colectomy or subtotal colectomy has become the preferred type of surgery for slow-transit constipation treatment. There are different opinions on intestinal anastomosis and the specific scope of excision. There is a type of surgery reserving the ileocecum, as the ileocaecal valve has the function of postponing the fecal evacuation. There's also a type of surgery excising the ileocecum , and establishing the pouch, as reserving the ileocecum may cause the recurrence of constipation, and establishing the pouch has function of relieving the postoperative fecal incontinence. On the basis, our own type of surgery is designed; ileocecum is excised for preventing the recurrence of constipation, while the anti-peristaltic ileosigmoid anastomosis between the small intestine and part of sigmoid is made for preventing the severe diarrhea.
Methods and techniques:
The data of patients with STC preformed surgery of laparoscopic subtotal colectomy with anti-peristaltic ileosigmoid anastomosis during 2009.01-2014.05 was reviewed. The related status such as frequency of defecation, course of constipation, laxatives use condition the condition of using laxatives, and changes in weight were investigated. Changes of defecation and weight, periprocedural complications (wound infection, lung infection and intestinal fistula), long-term complication (malnutrition, abdominal pain, ileus), life satisfaction, wexner score of pre-operation and postoperation ect were investigated in follow-ups.
Surgical operation process:
1,Laparoscope Sub-total Colectomy： After the entire colon mobilization,the ileum is resected at 10cm from ileocecum and 10-15cm colon up to peritoneal reflection is reserved. The ileocolic artery should be reserved carefully.2, Intestinal tract reconstruction: The terminal ileum is turned over 180°in anti-clockwise direction along the superior mesenteric vein long axis. To avoid the small mesenteric torsion, we should turn the broken edge towards inside. The terminal ileum and 10-15cm colon anastomose in anti-peristaltic direction,the anastomotic length is 8-10 cm.3, Sewn the space between anastomotic Intestine and posterior peritoneum. A drain is placed in the abdominal cavity and another one is placed in anal canal.
- Conditions
- Constipation
- Being tested
- Anti-peristaltic ileosigmoid anastomosis
- Keywords
- slow-transit constipation, laparoscope Sub-total Colectomy, anti-peristaltic anastomosis
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-peristaltic ileosigmoid anastomosisProcedure or surgery
1,Laparoscope Sub-total Colectomy： After the entire colon mobilization,the ileum is resected at 10cm from ileocecum and 10-15cm colon up to peritoneal reflection is reserved. The ileocolic artery should be reserved carefully.2, Intestinal tract reconstruction: The terminal ileum is turned over 180°in anti-clockwise direction along the superior mesenteric vein long axis. To avoid the small mesenteric torsion , we should turn the broken edge towards inside. The terminal ileum and 10-15cm colon anastomose in anti-peristaltic direction,the anastomotic length is 8-10 cm.3, Sewn the space between anastomotic Intestine and posterior peritoneum. A drain is placed in the abdominal cavity and another one is placed in anal canal.
| Study group | Role | What they receive |
|---|---|---|
| antiperistaltic ileosigmoid anastomosis | Experimental | To assess the operative results after laparoscope subtotal colectomy with antiperistaltic ileosigmoid anastomosis for the slow-transit constipation. Receives: Procedure: Anti-peristaltic ileosigmoid anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of signs and symptoms associated with constipation complication
Measured: preoperative, and at 6 months postoperative
Secondary outcomes (1)
Improvement of signs and symptoms associated with constipation complication
Measured: preoperative, at 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startDec 2009
- Primary completionJan 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anlong Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anlong Zhu, First Affiliated Hospital of Harbin Medical University
- Investigators
- anlong zhu, postdoctor, Study chair, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147574
- Sponsor's protocol ID
- zhuanlone0001
- Other IDs
- fahhmuzal0001
- Status last verified
- May 2014
- First submitted
- 8 May 2014
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscope Subtotal Colectomy With Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation
- ClinicalTrials.gov ID
- NCT02147574
- Acronym / sponsor ID
- zhuanlone0001
- Conditions
- Constipation
- Keywords
- slow-transit constipation, laparoscope Sub-total Colectomy, anti-peristaltic anastomosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Anlong ZhuUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 May 2014 (estimated)
- 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.
Purpose:
To evaluate the curative effect of Laparoscope Sub-total Colectomy with Anti-peristaltic ileosigmoid anastomosis for the treatment of slow-transit constipation on the patients with STC.
Methods and techniques:
The data of patients with STC preformed surgery of laparoscopic subtotal colectomy with anti-peristaltic ileosigmoid anastomosis during 2009.01-2014.05 was reviewed. The related status such as frequency of defecation, course of constipation, laxatives use condition the condition of using laxatives, and changes in weight were investigated. Changes of defecation and weight, periprocedural complications (wound infection, lung infection and intestinal fistula), long-term complication (malnutrition, abdominal pain, ileus), life satisfaction, wexner score of pre-operation and postoperation ect were investigated in follow-ups.
Detailed description
Theoretical Basis:
As far as the current research status, total colectomy or subtotal colectomy has become the preferred type of surgery for slow-transit constipation treatment. There are different opinions on intestinal anastomosis and the specific scope of excision. There is a type of surgery reserving the ileocecum, as the ileocaecal valve has the function of postponing the fecal evacuation. There's also a type of surgery excising the ileocecum , and establishing the pouch, as reserving the ileocecum may cause the recurrence of constipation, and establishing the pouch has function of relieving the postoperative fecal incontinence. On the basis, our own type of surgery is designed; ileocecum is excised for preventing the recurrence of constipation, while the anti-peristaltic ileosigmoid anastomosis between the small intestine and part of sigmoid is made for preventing the severe diarrhea.
Methods and techniques:
The data of patients with STC preformed surgery of laparoscopic subtotal colectomy with anti-peristaltic ileosigmoid anastomosis during 2009.01-2014.05 was reviewed. The related status such as frequency of defecation, course of constipation, laxatives use condition the condition of using laxatives, and changes in weight were investigated. Changes of defecation and weight, periprocedural complications (wound infection, lung infection and intestinal fistula), long-term complication (malnutrition, abdominal pain, ileus), life satisfaction, wexner score of pre-operation and postoperation ect were investigated in follow-ups.
Surgical operation process:
1,Laparoscope Sub-total Colectomy： After the entire colon mobilization,the ileum is resected at 10cm from ileocecum and 10-15cm colon up to peritoneal reflection is reserved. The ileocolic artery should be reserved carefully.2, Intestinal tract reconstruction: The terminal ileum is turned over 180°in anti-clockwise direction along the superior mesenteric vein long axis. To avoid the small mesenteric torsion, we should turn the broken edge towards inside. The terminal ileum and 10-15cm colon anastomose in anti-peristaltic direction,the anastomotic length is 8-10 cm.3, Sewn the space between anastomotic Intestine and posterior peritoneum. A drain is placed in the abdominal cavity and another one is placed in anal canal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antiperistaltic ileosigmoid anastomosis | Experimental | Procedure: Anti-peristaltic ileosigmoid anastomosisTo assess the operative results after laparoscope subtotal colectomy with antiperistaltic ileosigmoid anastomosis for the slow-transit constipation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- the clinical diagnose of STC
- Severe symptoms of constipation, defecating less than 2 times per week, no awareness of defecation, using laxatives to help defecation or there's no effects of laxatives.
- Symptoms of constipation last at least 2 years, and ineffective effects received from medicine treatment for more than one year.
- Colorectal organic disease was excluded
- More than one colonic transit trials suggest dysfunction of colon transport, no significant intestinal transit dysfunction
Key exclusion criteria (3 listed)
- significant mental disorder
- surgical contraindications
- Can't accept surgery subjectively
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 |
|---|---|---|
| Anti-peristaltic ileosigmoid anastomosis1,Laparoscope Sub-total Colectomy： After the entire colon mobilization,the ileum is resected at 10cm from ileocecum and 10-15cm colon up to peritoneal reflection is reserved. The ileocolic artery should be reserved carefully.2, Intestinal tract reconstruction: The terminal ileum is turned over 180°in anti-clockwise direction along the superior mesenteric vein long axis. To avoid the small mesenteric torsion , we should turn the broken edge towards inside. The terminal ileum and 10-15cm colon anastomose in anti-peristaltic direction,the anastomotic length is 8-10 cm.3, Sewn the space between anastomotic Intestine and posterior peritoneum. A drain is placed in the abdominal cavity and another one is placed in anal canal. | Procedure or surgery | antiperistaltic ileosigmoid anastomosis |
Primary outcome
Improvement of signs and symptoms associated with constipation complication
Time frame: preoperative, and at 6 months postoperative
1 secondary outcome
Improvement of signs and symptoms associated with constipation complication
Time frame: preoperative, at 12 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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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.
anlong zhu, postdoctor study chair
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anti-peristaltic ileosigmoid anastomosis in people with Constipation, run by Anlong Zhu 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 28 May 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of signs and symptoms associated with constipation complication (time frame: preoperative, and at 6 months postoperative). 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 28 May 2014.