Clinical trial NCT02234219: Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease
Official title: Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Constipation
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 177
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: bowel function score
timeFrame: 2 years
Secondary outcomes:
measure: rate of postoperative complication
timeFrame: 1month/6 month/12 month/2 years
measure: rate of reoperation
timeFrame: 1month/6 month/12 month/2 years
measure: rate of readmission
timeFrame: 1month/6 month/12 month/2 years
measure: bowel function score
timeFrame: 1 month/6 month/12 month
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Department of Pediatric surgery, Tongji hospital, HUST, Wuhan
name: Jiexiong Feng, MD.
role: PRINCIPAL_INVESTIGATOR
References: