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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 16
SponsorUniversity Hospital, Angers

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • transanal or laparoscopy assisted Swenson coloanal pullthrough

    Procedure/Surgery

    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

Treatment groups

70 Participants
are divided into 3 treatment groups
Group A: SIL-Swenson1 intervention
Group B: CL-Swenson1 intervention
Group C: TA-Swenson0 interventions

Trial outcomes

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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