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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02234219
Enrollment
177
Registered
2014-09-09
Start date
2019-11-30
Completion date
2025-10-30
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

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.

Interventions

PROCEDUREHeart-shape anastomosis

a new operation approach for Hirschsprung disease

PROCEDURESoave anastomosis

traditional approach for Hirschsprung disease

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
bowel function score2 yearsAbility to control bowel movements, Feeling before bowel movement, Soiling, Defecation frequency, Constipation, Social problem

Secondary

MeasureTime frameDescription
rate of postoperative complication1month/6 month/12 month/2 yearsHAEC/anastomosis leakage/soiling/constipation recurrence et al.
rate of reoperation1month/6 month/12 month/2 yearsrate of reoperation
rate of readmission1month/6 month/12 month/2 yearsrate of readmission
bowel function score1 month/6 month/12 monthAbility to control bowel movements, Feeling before bowel movement, Soiling, Defecation frequency, Constipation, Social problem

Countries

China

Contacts

PRINCIPAL_INVESTIGATORJiexiong Feng, MD.

Department of Pediatric surgery, Tongji hospital, HUST, Wuhan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026