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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05461924
Other study ID # NanjingCH-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 15, 2022
Est. completion date August 20, 2023

Study information

Verified date November 2022
Source Nanjing Children's Hospital
Contact Weibing Tang, Dr
Phone 8613851683700
Email twbcn@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hirschsprung disease (HSCR) is characterized by the absence of ganglion cells (aganglionosis) in the distal bowel extending proximally for varying distances that results in persistent spasm in the affected bowel and functional intestinal obstruction. Patients can be classified as rectosigmoid HSCR when aganglionosis confined to the rectosigmoid and long-segment or total colonic HSCR when aganglionosis extends beyond the upper sigmoid. Aganglionosis of long-segment HSCR can extend to the descending colon, transverse colon, ascending colon, but not to the terminal ileum. To date, there is insufficient evidence to recommend a preferred or superior method for the surgical repair for long-segment HSCR. In general, a pull-through with standard of care for the intestine and mesentery, which avoids excessive resection of the colon and coloanal reconstruction, is performed for long-segment HSCR.There are reports that a significant percentage of long-segment HSCR patients continue to have difficulty with soiling and incontinence,however there were also reports long-segment HSCR patients have the same continece as rectosigmoid HSCR.The outcome of long-segment HSCR should be thoroughly evaluated. The present study was designed to evaluate the long-term outcomes of long-segment HSCR.


Description:

Hirschsprung disease (HSCR) is characterized by the absence of ganglion cells (aganglionosis) in the distal bowel extending proximally for varying distances that results in persistent spasm in the affected bowel and functional intestinal obstruction. Patients can be classified as rectosigmoid HSCR when aganglionosis confined to the rectosigmoid and long-segment or total colonic HSCR when aganglionosis extends beyond the upper sigmoid. Aganglionosis of long-segment HSCR can extend to the descending colon, transverse colon, ascending colon, but not to the terminal ileum. To date, there is insufficient evidence to recommend a preferred or superior method for the surgical repair for long-segment HSCR. In general, a pull-through with standard of care for the intestine and mesentery, which avoids excessive resection of the colon and coloanal reconstruction, is performed for long-segment HSCR.There are reports that a significant percentage of long-segment HSCR patients continue to have difficulty with soiling and incontinence,however there were also reports long-segment HSCR patients have the same continece as rectosigmoid HSCR.The outcome of long-segment HSCR should be thoroughly evaluated. The present study was designed to evaluate the long-term outcomes of long-segment HSCR. The long-term outcome would be indicated by bowel function SCORE.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 20, 2023
Est. primary completion date August 20, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years and older
Eligibility Inclusion Criteria: Clinical diagnosis of Hirschsprung disease Must be performed with the operation of pull-through Must be followed up more than 3 years Exclusion Criteria: Clinical diagnosis of Down syndrome Clinical diagnosis of tolal colonic Hirschsprung disease Clinical diagnosis of degestive malformation except Hirschsprung disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire survey
questionnaire survey the long term outcomes of long-segment HSCR and compared with rectosigmoid HSCR

Locations

Country Name City State
China Children's Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Weibing Tang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bowel function score Bowel function was evaluated by the BFS (20 points), which was approved by Rintala in 1995 ; patients with a score > 18 were considered to have normal bowel habits. through study completion, an average of 5 year
Secondary Hirschspurng disease associated entrocolitis(HAEC) The guidelines for the diagnosis and management of HAEC were defined by the American Pediatric Surgical Association in 2017 through study completion, an average of 5 year
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