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

NCT07468565 | Not Yet Recruiting

• 1 other identifier: 49RC25_0501
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hirschsprung Disease

Keywords

Swenson Technique; Single-Port Laparoscopy; Pediatric surgery; Postoperative outcomes; Hirschsprung disease

Outcome Measures

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

  From surgery to 12 months postoperatively

Secondary Outcomes (5)

• To compare intraoperativensurgical efficiency according to surgical approach

  During surgery (day 0)

• To compare immediate postoperative recovery

  At hospital discharge (average 5 days)

• Short-term complications

  From hospital discharge to 30 days after surgery

• Long-term complications

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

• Long-term continence outcomes

  Assessed after toilet training age (≥3-4 years old) and up to the last clinical follow-up visit (mean follow-up: 5.5 years)

Study Arms (3)

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

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

CL-Swenson; SIL-Swenson

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• SCHMITT Françoise

  University Hospital of Angers

  STUDY CHAIR

Central Study Contacts

SCHMITT Françoise

CONTACT

0241353637; FrSchmitt@chu-angers.fr

SCHMITT Françoise

CONTACT

FrSchmitt@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 12, 2026
• Study Start: March 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-02