Hirschsprung DiseaseSMILESNCT07468565
Surgical Approach for the Treatment of Hirschsprung Disease Using the Swenson Technique (SMILES)
An observational study of Hirschsprung Disease, run by University Hospital, Angers.
Trial summary
Hirschsprung disease (HD) is a rare congenital disorder of the enteric nervous system, affecting approximately 1 in 5,000 live births. It is characterized by the absence of ganglion cells in the distal colon, leading to functional intestinal obstruction due to impaired peristalsis. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Hirschsprung Disease
- What is being tested?
- transanal or laparoscopy assisted Swenson coloanal pullthrough
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under 16 years of age with diagnosis of Hirschsprung disease confirmed by initial rectal biopsy and postoperative pathological examination
Who may be able to join
- Children under 16 years of age
- Diagnosis of Hirschsprung disease confirmed by initial rectal biopsy and postoperative pathological examination
- Primary Swenson coloanal pull-through performed at Angers or Caen University Hospital between January 1, 2010 and June 30, 2025
Who cannot join
- Parental or legal guardian opposition to the use of medical data for research purposes
- Hirschsprung disease treated with other surgical techniques (Duhamel, Soave, De La Torre, TERPT)
- Patients operated on in another hospital
- Patients who underwent rectosigmoid resection for causes of constipation other than Hirschsprung disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
SCHMITT Françoise contact
About this study
Official title: A Bicenter Retrospective Comparative Study of the Surgical Approach for the Treatment of Hirschsprung Disease Using the Swenson Technique
Hirschsprung disease (HD) is a rare congenital disorder of the enteric nervous system, affecting approximately 1 in 5,000 live births. It is characterized by the absence of ganglion cells in the distal colon, leading to functional intestinal obstruction due to impaired peristalsis. Surgical treatment consists of resection of the aganglionic segment-most commonly rectosigmoid-followed by a colo-rectal, colo-anal, or ileo-anal anastomosis.
Among colo-anal pull-through procedures, the Swenson technique was historically performed through an exclusively transanal approach, which carries a risk of sphincter injury correlated with operative duration. More recently, combined laparoscopic and transanal approaches have been developed to reduce this risk, although they may be associated with higher overall complication and reoperation rates.
Read more
The Swenson procedure can be performed using a single-port laparoscopic approach, a technique that is sparsely described in the literature and rarely practiced in France. Single-port laparoscopy represents an emerging surgical technique that, despite increased technical complexity for surgeons, may further enhance postoperative recovery and cosmetic outcomes compared to conventional multiport laparoscopy.
The objective of this study is to describe the outcomes of single-port laparoscopic Swenson pull-through in children with Hirschsprung disease and to compare them with outcomes obtained using more conventional approaches, namely exclusive transanal surgery or combined multiport laparoscopic and transanal approaches.
- Conditions
- Hirschsprung Disease
- Being tested
- transanal or laparoscopy assisted Swenson coloanal pullthrough
- Keywords
- Swenson Technique, Single-Port Laparoscopy, Pediatric surgery, Postoperative outcomes, Hirschsprung disease
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transanal or laparoscopy assisted Swenson coloanal pullthroughProcedure or surgery
TA-Swenson consist of total trananal endorectal pullthrough after a short submucosal dissection of the last part of the rectum.
Laparoscopy-assisted Swenson pull-through consists of laparoscopic mobilization of the aganglionic colon with intraoperative level confirmation, followed by a transanal resection of the aganglionic segment and a primary coloanal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| SIL-Swenson | Swenson coloanal pullthrough with single incision laparoscopy Receives: Procedure: transanal or laparoscopy assisted Swenson coloanal pullthrough | |
| CL-Swenson | Swenson coloanal pullthrough with conventional (multiport) laparoscopy Receives: Procedure: transanal or laparoscopy assisted Swenson coloanal pullthrough | |
| TA-Swenson | Swenson coloanal pullthrough with exclusive trananal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the short-term effectiveness of different surgical laparoscopic approaches used for the Swenson technique.
Short-term effectiveness, defined as spontaneous bowel transit without obstructive-spectrum events during the first postoperative year, including:
- Constipation
- Delayed resumption of oral feeding
- Sphincter hypertonicity
- Hirschsprung-associated enterocolitis
Measured: From surgery to 12 months postoperatively
Secondary outcomes (5)
To compare intraoperativensurgical efficiency according to surgical approach
Surgical efficiency, defined as operative time for coloanal anastomosis completion without conversion, including the approach for intraoperative frozen-section biopsy.
Measured: During surgery (day 0)
To compare immediate postoperative recovery
Recovery, defined as hospital discharge in good health, which includes:
- Return of bowel function
- Resumption of oral feeding
- Absence of early postoperative complications, particularly infectious complications (surgical site infection, intra-abdominal infection, sepsis)
Measured: At hospital discharge (average 5 days)
Short-term complications
All early postoperative complications graded according to the Clavien-Madadi classification
Measured: From hospital discharge to 30 days after surgery
Long-term complications
All late postoperative complications graded according to the Clavien-Madadi classification
Measured: From 31 days after surgery up to the last clinical follow-up visit (mean follow-up: 5.5 years)
Long-term continence outcomes
Assessed using the Krickenbeck score, which includes:
- Bowel movements perception
- Soining (graded 0 - absence to 3 - constant/social prolem)
- Constipation (graded from 0 - absence to 3 - resistant to diet and laxatives)
Measured: Assessed after toilet training age (≥3-4 years old) and up to the last clinical follow-up visit (mean follow-up: 5.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- SCHMITT Françoise, Study chair, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468565
- Sponsor's protocol ID
- 49RC25_0501
- Acronym
- SMILES
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bicenter Retrospective Comparative Study of the Surgical Approach for the Treatment of Hirschsprung Disease Using the Swenson Technique
- ClinicalTrials.gov ID
- NCT07468565
- Acronym / sponsor ID
- SMILES / 49RC25_0501
- Conditions
- Hirschsprung Disease
- Keywords
- Swenson Technique, Single-Port Laparoscopy, Pediatric surgery, Postoperative outcomes, Hirschsprung disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- 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.
Hirschsprung disease (HD) is a rare congenital disorder of the enteric nervous system, affecting approximately 1 in 5,000 live births. It is characterized by the absence of ganglion cells in the distal colon, leading to functional intestinal obstruction due to impaired peristalsis. Surgical treatment consists of resection of the aganglionic segment-most commonly rectosigmoid-followed by a colo-rectal, colo-anal, or ileo-anal anastomosis.
Among colo-anal pull-through procedures, the Swenson technique was historically performed through an exclusively transanal approach, which carries a risk of sphincter injury correlated with operative duration. More recently, combined laparoscopic and transanal approaches have been developed to reduce this risk, although they may be associated with higher overall complication and reoperation rates.
The Swenson procedure can be performed using a single-port laparoscopic approach, a technique that is sparsely described in the literature and rarely practiced in France. Single-port laparoscopy represents an emerging surgical technique that, despite increased technical complexity for surgeons, may further enhance postoperative recovery and cosmetic outcomes compared to conventional multiport laparoscopy.
The objective of this study is to describe the outcomes of single-port laparoscopic Swenson pull-through in children with Hirschsprung disease and to compare them with outcomes obtained using more conventional approaches, namely exclusive transanal surgery or combined multiport laparoscopic and transanal approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SIL-Swenson | – | Procedure: transanal or laparoscopy assisted Swenson coloanal pullthroughSwenson coloanal pullthrough with single incision laparoscopy |
| CL-Swenson | – | Procedure: transanal or laparoscopy assisted Swenson coloanal pullthroughSwenson coloanal pullthrough with conventional (multiport) laparoscopy |
| TA-Swenson | – | –Swenson coloanal pullthrough with exclusive trananal approach |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under 16 years of age with diagnosis of Hirschsprung disease confirmed by initial rectal biopsy and postoperative pathological examination
Key inclusion criteria (3 listed)
- Children under 16 years of age
- Diagnosis of Hirschsprung disease confirmed by initial rectal biopsy and postoperative pathological examination
- Primary Swenson coloanal pull-through performed at Angers or Caen University Hospital between January 1, 2010 and June 30, 2025
Key exclusion criteria (4 listed)
- Parental or legal guardian opposition to the use of medical data for research purposes
- Hirschsprung disease treated with other surgical techniques (Duhamel, Soave, De La Torre, TERPT)
- Patients operated on in another hospital
- Patients who underwent rectosigmoid resection for causes of constipation other than Hirschsprung disease
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 |
|---|---|---|
| transanal or laparoscopy assisted Swenson coloanal pullthroughTA-Swenson consist of total trananal endorectal pullthrough after a short submucosal dissection of the last part of the rectum. Laparoscopy-assisted Swenson pull-through consists of laparoscopic mobilization of the aganglionic colon with intraoperative level confirmation, followed by a transanal resection of the aganglionic segment and a primary coloanal anastomosis | Procedure or surgery | CL-Swenson, SIL-Swenson |
Primary outcome
To compare the short-term effectiveness of different surgical laparoscopic approaches used for the Swenson technique.
Time frame: From surgery to 12 months postoperatively
Short-term effectiveness, defined as spontaneous bowel transit without obstructive-spectrum events during the first postoperative year, including: * Constipation * Delayed resumption of oral feeding * Sphincter hypertonicity * Hirschsprung-associated enterocolitis
5 secondary outcomes
To compare intraoperativensurgical efficiency according to surgical approach
Time frame: During surgery (day 0)
To compare immediate postoperative recovery
Time frame: At hospital discharge (average 5 days)
Short-term complications
Time frame: From hospital discharge to 30 days after surgery
Long-term complications
Time frame: From 31 days after surgery up to the last clinical follow-up visit (mean follow-up: 5.5 years)
Long-term continence outcomes
Time frame: Assessed after toilet training age (≥3-4 years old) and up to the last clinical follow-up visit (mean follow-up: 5.5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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.
SCHMITT Françoise contact
SCHMITT Françoise study chair
University Hospital of Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Hirschsprung Disease, run by University Hospital, Angers.
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 4 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SCHMITT Françoise (0241353637 ext. +33, FrSchmitt@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the short-term effectiveness of different surgical laparoscopic approaches used for the Swenson technique. (time frame: From surgery to 12 months postoperatively). 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 12 Mar 2026.