- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02147574
Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Heilongjiang
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Harbin, Heilongjiang, China, 150000
- The First Affiliated Hospital Of Harbin Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- significant mental disorder
- surgical contraindications
- Can't accept surgery subjectively
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: antiperistaltic ileosigmoid anastomosis
To assess the operative results after laparoscope subtotal colectomy with antiperistaltic ileosigmoid anastomosis for the slow-transit constipation.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of signs and symptoms associated with constipation complication
Time Frame: preoperative, and at 6 months postoperative
|
preoperative, and at 6 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of signs and symptoms associated with constipation complication
Time Frame: preoperative, at 12 months postoperative
|
preoperative, at 12 months postoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: anlong zhu, postdoctor, First Affiliated Hospital of Harbin Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- zhuanlone0001
- fahhmuzal0001 (Other Identifier: FirstAHHarbinMU)
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