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Completed

NCT Number: NCT02234219

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

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

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Key information

Age range

3 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Heart-shape anastomosis

Procedure

a new operation approach for Hirschsprung disease

Soave anastomosis

Procedure

traditional approach for Hirschsprung disease

Primary outcomes

  1. bowel function score

    Time frame: 2 years

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

Secondary outcomes

  1. rate of postoperative complication

    Time frame: 1month/6 month/12 month/2 years

    HAEC/anastomosis leakage/soiling/constipation recurrence et al.

  2. rate of reoperation

    Time frame: 1month/6 month/12 month/2 years

    rate of reoperation

  3. rate of readmission

    Time frame: 1month/6 month/12 month/2 years

    rate of readmission

  4. bowel function score

    Time frame: 1 month/6 month/12 month

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

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
Sep 9, 2014
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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