ConstipationNCT02234219
Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease
A study testing Heart-shape anastomosis and Soave anastomosis in people with Constipation, run by Tongji Hospital at 1 site in China.
Trial summary
Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease. Read more about this study
- Who is it for?
- Ages 3 months to 14 years
- Conditions the study is for
- Constipation
- What is being tested?
- Heart-shape anastomosis and Soave anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2019to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age<14 years
- Hirschsprung's disease diagnosed by biopsy
- Surgical indication
Who cannot join
- Age>14 years
- Not Hirschsprung's disease
- Surgical contraindication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Heart-shape anastomosis, Soave anastomosis
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart-shape anastomosisProcedure or surgery
a new operation approach for Hirschsprung disease
Soave anastomosisProcedure or surgery
traditional approach for Hirschsprung disease
| Study group | Role | What they receive |
|---|---|---|
| Heart-shaped anastomosis | Experimental | Heart shaped anastomosis Receives: Procedure: Heart-shape anastomosis |
| Circle anastomosis | Active comparator | Soave anastomosis Receives: Procedure: Soave anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel function score
Ability to control bowel movements, Feeling before bowel movement, Soiling, Defecation frequency, Constipation, Social problem
Measured: 2 years
Secondary outcomes (4)
rate of postoperative complication
HAEC/anastomosis leakage/soiling/constipation recurrence et al.
Measured: 1month/6 month/12 month/2 years
rate of reoperation
rate of reoperation
Measured: 1month/6 month/12 month/2 years
rate of readmission
rate of readmission
Measured: 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
Measured: 1 month/6 month/12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start30 Nov 2019
- Primary completion30 Oct 2023
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiexiong Feng, Tongji Hospital
- Investigators
- Jiexiong Feng, MD., Principal investigator, Department of Pediatric surgery, Tongji hospital, HUST, Wuhan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234219
- Sponsor's protocol ID
- Anastomosis in Hirschsprung
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2014
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02234219
- Acronym / sponsor ID
- Anastomosis in Hirschsprung
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart-shaped anastomosis | Experimental | Procedure: Heart-shape anastomosisHeart shaped anastomosis |
| Circle anastomosis | Active comparator | Procedure: Soave anastomosisSoave anastomosis |
Who may qualify
- Ages
- 3 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age<14 years
- Hirschsprung's disease diagnosed by biopsy
- Surgical indication
Key exclusion criteria (3 listed)
- Age>14 years
- Not Hirschsprung's disease
- Surgical contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart-shape anastomosisa new operation approach for Hirschsprung disease | Procedure or surgery | Heart-shaped anastomosis |
| Soave anastomosistraditional approach for Hirschsprung disease | Procedure or surgery | Circle anastomosis |
Primary outcome
bowel function score
Time frame: 2 years
Ability to control bowel movements, Feeling before bowel movement, Soiling, Defecation frequency, Constipation, Social problem
4 secondary outcomes
rate of postoperative complication
Time frame: 1month/6 month/12 month/2 years
rate of reoperation
Time frame: 1month/6 month/12 month/2 years
rate of readmission
Time frame: 1month/6 month/12 month/2 years
bowel function score
Time frame: 1 month/6 month/12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiexiong Feng, MD. principal investigator
Department of Pediatric surgery, Tongji hospital, HUST, Wuhan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart-shape anastomosis and Soave anastomosis in people with Constipation, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bowel function score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.