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Robot-Assisted surgery showdown: which fix works best for rare bowel disease?

NCT ID NCT07343622

Disease control Sponsor: Zunyi Medical College Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two surgical techniques—Duhamel and Soave—for treating total colonic Hirschsprung disease, a severe birth defect where nerve cells are missing from the colon. Fifty children who had a first surgery as newborns will receive one of the two procedures. Researchers will track bowel function and infection rates for two years to see which method works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Surgical procedure (Duhamel or Soave pull-through)
What this could lead to
If this trial succeeds, it could help doctors choose the best surgical approach for children with severe Hirschsprung disease, improving bowel function and reducing complications.
What could go wrong
This is a small, early-stage trial with only 50 participants, so results may not apply to all patients. Both surgeries have known risks like infection or bowel issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 14 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Definitive diagnosis of total colonic Hirschsprung disease confirmed by pathology from biopsy at neonatal enterostomy, consistent with total colonic aganglionosis. 2. Two-stage surgical strategy: neonatal enterostomy performed first, followed by definitive pull-through as a second-stage procedure. 3. Planned definitive reconstruction by one of the following techniques: 4. Robot-assisted transanal transection Duhamel, orModified Soave pull-through (minimally invasive abdominal phase allowed). 5. Availability for follow-up assessments and outcomes collection per protocol. Exclusion Criteria: 1. Trisomy 21 (Down syndrome). 2. Definitive surgery performed by open laparotomy approach or Swenson procedure. 3. One-stage primary pull-through without neonatal enterostomy (single-stage definitive management).

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Conditions

The condition(s) this trial relates to.

aganglionosis, total intestinal dyschromatosis universalis hereditaria Hirschsprung disease southeast Asian ovalocytosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Duhamel Hirschsprung disease SOAVE Total colonic aganglionosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000, China

More trials for these conditions

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