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

May 20, 2014 updated by: Anlong Zhu

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

Completed

Conditions

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

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • The First Affiliated Hospital Of Harbin Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: anlong zhu, postdoctor, First Affiliated Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • zhuanlone0001
  • fahhmuzal0001 (Other Identifier: FirstAHHarbinMU)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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