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

Not Applicable

Active, not recruiting

• Conditions: Constipation
• Interventions: Procedure: Heart-shape anastomosis; Procedure: Soave anastomosis

• Registration Number: NCT02234219
• Lead Sponsor: Tongji Hospital

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 Timeline

• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-09
• Study Start: 2019-11-30
• Primary Completion: 2023-10-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-17
• Last Update Posted: 2025-05-21
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 177

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heart-shaped anastomosis	Heart-shape anastomosis	Heart shaped anastomosis
Circle anastomosis	Soave anastomosis	Soave anastomosis

Primary Outcome Measures

Name	Time	Method
bowel function score	2 years	Ability to control bowel movements, Feeling before bowel movement, Soiling, Defecation frequency, Constipation, Social problem

Secondary Outcome Measures

Name	Time	Method
rate of readmission	1month/6 month/12 month/2 years	rate of readmission
bowel function score	1 month/6 month/12 month	Ability to control bowel movements, Feeling before bowel movement, Soiling, Defecation frequency, Constipation, Social problem
rate of postoperative complication	1month/6 month/12 month/2 years	HAEC/anastomosis leakage/soiling/constipation recurrence et al.
rate of reoperation	1month/6 month/12 month/2 years	rate of reoperation

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China