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

NCT ID: NCT02234219

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2025-10-30

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heart-shaped anastomosis

Heart shaped anastomosis

Group Type: EXPERIMENTAL

Heart-shape anastomosis

Intervention Type: PROCEDURE

a new operation approach for Hirschsprung disease

Circle anastomosis

Soave anastomosis

Group Type: ACTIVE_COMPARATOR

Soave anastomosis

Intervention Type: PROCEDURE

traditional approach for Hirschsprung disease

Interventions

Heart-shape anastomosis

a new operation approach for Hirschsprung disease

Intervention Type: PROCEDURE

Soave anastomosis

traditional approach for Hirschsprung disease

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiexiong Feng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiexiong Feng, MD.

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatric surgery, Tongji hospital, HUST, Wuhan

Locations

Tongji Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

Anastomosis in Hirschsprung

Identifier Type: -

Identifier Source: org_study_id