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Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation

Primary Purpose

Constipation

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Anti-peristaltic ileosigmoid anastomosis
Sponsored by
Anlong Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring slow-transit constipation, laparoscope Sub-total Colectomy, anti-peristaltic anastomosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Harbin Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

antiperistaltic ileosigmoid anastomosis

Arm Description

To assess the operative results after laparoscope subtotal colectomy with antiperistaltic ileosigmoid anastomosis for the slow-transit constipation.

Outcomes

Primary Outcome Measures

Improvement of signs and symptoms associated with constipation complication

Secondary Outcome Measures

Improvement of signs and symptoms associated with constipation complication

Full Information

First Posted
May 8, 2014
Last Updated
May 20, 2014
Sponsor
Anlong Zhu
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1. Study Identification

Unique Protocol Identification Number
NCT02147574
Brief Title
Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation
Official Title
Laparoscope Subtotal Colectomy With Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anlong Zhu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
slow-transit constipation, laparoscope Sub-total Colectomy, anti-peristaltic anastomosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
antiperistaltic ileosigmoid anastomosis
Arm Type
Experimental
Arm Description
To assess the operative results after laparoscope subtotal colectomy with antiperistaltic ileosigmoid anastomosis for the slow-transit constipation.
Intervention Type
Procedure
Intervention Name(s)
Anti-peristaltic ileosigmoid anastomosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of signs and symptoms associated with constipation complication
Time Frame
preoperative, and at 6 months postoperative
Secondary Outcome Measure Information:
Title
Improvement of signs and symptoms associated with constipation complication
Time Frame
preoperative, at 12 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
anlong zhu, postdoctor
Organizational Affiliation
First Affiliated Hospital of Harbin Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China

12. IPD Sharing Statement

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Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation

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