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

NCT02147574 | Completed Phase 4 DMC

• 2 other identifiers: zhuanlone0001fahhmuzal0001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

slow-transit constipation; laparoscope Sub-total Colectomy; anti-peristaltic anastomosis

Outcome Measures

Primary Outcomes (1)

• Improvement of signs and symptoms associated with constipation complication

  preoperative, and at 6 months postoperative

Secondary Outcomes (1)

• Improvement of signs and symptoms associated with constipation complication

  preoperative, at 12 months postoperative

Study Arms (1)

antiperistaltic ileosigmoid anastomosis

EXPERIMENTAL

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

Procedure: Anti-peristaltic ileosigmoid anastomosis

Interventions

Anti-peristaltic ileosigmoid anastomosis PROCEDURE

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.

antiperistaltic ileosigmoid anastomosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• significant mental disorder
• surgical contraindications
• Can't accept surgery subjectively

Sponsors & Collaborators

• Anlong Zhu: lead

Study Sites (1)

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• anlong zhu, postdoctor

  First Affiliated Hospital of Harbin Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chairman

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 28, 2014
• Study Start: December 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

CN (1)