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

T

Tongji Hospital

Status

Active, not recruiting

Conditions

Constipation

Treatments

Procedure: Heart-shape anastomosis
Procedure: Soave anastomosis

Study type

Interventional

Funder types

Other

Identifiers

NCT02234219
Anastomosis in Hirschsprung

Details and patient eligibility

About

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

Full 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.

Enrollment

177 patients

Sex

All

Ages

3 months to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age<14 years
  2. Hirschsprung's disease diagnosed by biopsy
  3. Surgical indication

Exclusion criteria

  1. Age>14 years
  2. Not Hirschsprung's disease
  3. Surgical contraindication

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

177 participants in 2 patient groups

Heart-shaped anastomosis
Experimental group
Description:
Heart shaped anastomosis
Treatment:
Procedure: Heart-shape anastomosis
Circle anastomosis
Active Comparator group
Description:
Soave anastomosis
Treatment:
Procedure: Soave anastomosis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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