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Not yet recruitingNCT07468565SMILESUpdated Mar 12, 2026

Surgical Approach for the Treatment of Hirschsprung Disease Using the Swenson Technique (SMILES)

An observational study in Hirschsprung Disease, sponsored by University Hospital, Angers. Not yet recruiting. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by University Hospital, Angers · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
70
Ages
Up to 16 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Hirschsprung Disease

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Keywords

  • Swenson Technique
  • Single-Port Laparoscopy
  • Pediatric surgery
  • Postoperative outcomes
  • Hirschsprung disease
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In context

Hirschsprung Disease

66 studies on the registry are indexed under Hirschsprung Disease; 23 are open to participants now.

This study's planned enrollment of 70 is below the median of 300 across 32 observational studies indexed under Hirschsprung Disease.

Browse Hirschsprung Disease studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children under 16 years of age with diagnosis of Hirschsprung disease confirmed by initial rectal biopsy and postoperative pathological examination

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria

  • 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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • SIL-Swenson

    Swenson coloanal pullthrough with single incision laparoscopy

    Procedure: transanal or laparoscopy assisted Swenson coloanal pullthrough

  • CL-Swenson

    Swenson coloanal pullthrough with conventional (multiport) laparoscopy

    Procedure: transanal or laparoscopy assisted Swenson coloanal pullthrough

  • TA-Swenson

    Swenson coloanal pullthrough with exclusive trananal approach

Interventions

  • Proceduretransanal or laparoscopy assisted Swenson coloanal pullthrough

    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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: From surgery to 12 months postoperatively

Secondary outcomes

  1. 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.

    Time frame: During surgery (day 0)

  2. 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)

    Time frame: At hospital discharge (average 5 days)

  3. Short-term complications

    All early postoperative complications graded according to the Clavien-Madadi classification

    Time frame: From hospital discharge to 30 days after surgery

  4. Long-term complications

    All late postoperative complications graded according to the Clavien-Madadi classification

    Time frame: From 31 days after surgery up to the last clinical follow-up visit (mean follow-up: 5.5 years)

  5. 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)

    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)

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07468565
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Mar 12, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Mar 12, 2026

Study contacts

SCHMITT Françoise
Contact
FrSchmitt@chu-angers.fr
0241353637 ext. +33
SCHMITT Françoise
Contact
FrSchmitt@chu-angers.fr
SCHMITT Françoise
study chair · University Hospital of Angers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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