Clinical Trial

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

Study acronym: SMILES
Not Yet Recruiting
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Record status
This record was last updated March 12, 2026 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07468565
Lead Sponsor University Hospital, Angers
Conditions Hirschsprung Disease
Enrollment 70 participants
Start Date 2026-03-01
Primary Completion 2026-06-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-12