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NCT Number: NCT07468565

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

transanal or laparoscopy assisted Swenson coloanal pullthrough

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. To compare intraoperativensurgical efficiency according to surgical approach

    Time frame: During surgery (day 0)

    Surgical efficiency, defined as operative time for coloanal anastomosis completion without conversion, including the approach for intraoperative frozen-section biopsy.

  2. To compare immediate postoperative recovery

    Time frame: At hospital discharge (average 5 days)

    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)
  3. Short-term complications

    Time frame: From hospital discharge to 30 days after surgery

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

  4. Long-term complications

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

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

  5. 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)

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

SCHMITT Françoise

CONTACT

[email protected]

0241353637 ext. +33

SCHMITT Françoise

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

A Bicenter Retrospective Comparative Study of the Surgical Approach for the Treatment of Hirschsprung Disease Using the Swenson Technique

Acronym: SMILES

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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