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

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

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Procedure: Heart-shape anastomosis; Procedure: Soave anastomosis

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 Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart-shaped anastomosis; Heart shaped anastomosis	Procedure: Heart-shape anastomosis; a new operation approach for Hirschsprung disease
Active Comparator: Circle anastomosis; Soave anastomosis	Procedure: Soave anastomosis; traditional approach for Hirschsprung disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bowel function score	Ability to control bowel movements, Feeling before bowel movement, Soiling, Defecation frequency, Constipation, Social problem	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Jiexiong Feng, MD., Department of Pediatric surgery, Tongji hospital, HUST, Wuhan

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2019
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: August 27, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimated): September 9, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation
• Other Study ID Numbers: Anastomosis in Hirschsprung

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No