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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Hirschsprung Disease
• Intervention / Treatment: Procedure: transanal or laparoscopy assisted Swenson coloanal pullthrough

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: SCHMITT Françoise; Phone Number: +33 0241353637; Email: FrSchmitt@chu-angers.fr
• Study Contact Backup: Name: SCHMITT Françoise; Email: FrSchmitt@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SIL-Swenson; Swenson coloanal pullthrough with single incision laparoscopy	Procedure: transanal 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
CL-Swenson; Swenson coloanal pullthrough with conventional (multiport) laparoscopy	Procedure: transanal 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
TA-Swenson; Swenson coloanal pullthrough with exclusive trananal approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	At hospital discharge (average 5 days)
Short-term complications	All early postoperative complications graded according to the Clavien-Madadi classification	From hospital discharge to 30 days after surgery
Long-term complications	All late postoperative complications graded according to the Clavien-Madadi classification	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)	Assessed after toilet training age (≥3-4 years old) and up to the last clinical follow-up visit (mean follow-up: 5.5 years)

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Study Chair: SCHMITT Françoise, University hospital of Angers

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Hirschsprung disease; Pediatric surgery; Postoperative outcomes; Single-Port Laparoscopy; Swenson Technique
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Congenital Abnormalities; Digestive System Abnormalities; Megacolon; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hirschsprung Disease
• Other Study ID Numbers: 49RC25_0501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No