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Clinical Trials/NCT02234219
NCT02234219CompletedNot Applicable

Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial

Tongji Hospital1 site in 1 country177 target enrollmentStarted: November 30, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
177
Locations
1
Primary Endpoint
bowel function score

Study Overview

Brief Summary

Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.

Detailed Description

At present, the treatment for children with HSCR is still surgery. The basic treatment principles of all surgical procedures commonly used in the world include confirming the location of the transitional zone between the intestinal tube with and without ganglion cells, removing the intestinal segment without ganglion cells, and reconstructing the digestive tract by anastomosis of the intestinal segment with ganglion cells with the anus or rectum. Intact anal receptors and autonomic internal sphincter control are essential for autonomic bowel control, and the integrity of the internal sphincter directly affects the occurrence of soilage and fecal incontinence after surgery. Therefore, how to deal with the internal sphincter during the operation, so as to avoid the recurrence of constipation caused by the spasm of the internal sphincter after the operation, and to retain the function of the internal sphincter for defecation control has been the focus of research.

In the 1980s, Professor Wang Guo, based on the experience of previous researchers, innovated the "heart-shaped anastomosis", which is a surgical procedure in which the dorsal rectum is split longitudinally to the dentate line without removing the internal sphincter, and then the normal colon is drawn out to make an oblique anastomosis with the rectoanal canal. A retrospective single-center follow-up of nearly 100 cases of "heart-shaped anastomosis" over a period of 20 years found that compared with traditional end-to-end colorectal anastomosis, patients with "heart-shaped anastomosis" had a significantly lower rate of fecal fouling and a long-term Bowel function score (Bowel function score, bowel function score). BFS) and Quality of Life-BREF (QLB) were also significantly improved compared with the traditional operation (P<0.05), and no other adverse events occurred. This study aims to determine the optimal surgical procedure for HSCR by a prospective, multicenter controlled study comparing the "heart-shaped anastomosis" with the commonly used Soave procedure.

In summary, this project will compare the application of "heart-shaped anastomosis" and traditional surgery for children with HSCR before operation, and comprehensively evaluate the advantages of "heart-shaped anastomosis" for defecation control from morphology to electrophysiological function through postoperative follow-up, combined with anorectal manometry.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None (Participant)

Eligibility Criteria

Ages
3 Months to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age<14 years
  • •Hirschsprung's disease diagnosed by biopsy
  • •Surgical indication

Exclusion Criteria

  • •Age>14 years
  • •Not Hirschsprung's disease
  • •Surgical contraindication

Arms & Interventions

Heart-shaped anastomosis

Experimental

Heart shaped anastomosis

Intervention: Heart-shape anastomosis (Procedure)

Circle anastomosis

Active Comparator

Soave anastomosis

Intervention: Soave anastomosis (Procedure)

Outcomes

Primary Outcomes

bowel function score

Time Frame: 2 years

Ability to control bowel movements, Feeling before bowel movement, Soiling, Defecation frequency, Constipation, Social problem

Secondary Outcomes

  • bowel function score(1 month/6 month/12 month)
  • rate of postoperative complication(1month/6 month/12 month/2 years)
  • rate of reoperation(1month/6 month/12 month/2 years)
  • rate of readmission(1month/6 month/12 month/2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jiexiong Feng

Professor

Tongji Hospital

Study Sites (1)

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