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OpenTrials
Completed

NCT Number: NCT07186647

Laparoscopic-Assisted Transanal Pull-Through for Hirschsprung Disease in Pediatric:Short and Intermediate Outcomes of Two Different Techniques

Compare the functional and surgical outcomes of laparoscopic-assisted Swenson-like (LASwL) and laparoscopic-assisted Soave (LASo) pull through in children with HD.

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Key information

Age range

1 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

pediatric surgery departments- Al-Azhar University Hospitals

Cairo, Egypt

About this study

A prospective, randomized study was conducted involving 80 patients diagnosed with HD at Al-Azhar University Hospitals over a 48-month period from September 2020 to August 2024. Participants were randomly allocated to the LASwL (Group A) or LASo (Group B). The primary outcome was the postoperative bowel function score. Secondary outcomes included operative time, blood loss, duration of hospital stay, and incidence of postoperative Hirschsprung-associated enterocolitis (HAEC).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • infants and children diagnosed with Hirschsprung's disease (HD) at the Department of Pediatric Surgery, Al-Azhar University Hospitals, from September 2020 to August 2024

Exclusion criteria

  • Patients with ultrashort or total colonic aganglionosis and those who had previously undergone pull-through procedures

Treatment and study plan

laparoscopic-assisted Swenson-like (LASwL)

Procedure

Following port placement, laparoscopic exploration was performed to evaluate the spastic colonic segment and transitional zone. An aperture was created in the sigmoid mesentery, and the sigmoid colon was mobilized. The proximal ganglionic bowel was mobilized while preserving the marginal arcades. The peritoneal reflection was sharply incised to facilitate dissection and mobilization of the aganglionic rectum. The procedure diverged between the two groups at this juncture: LASwl group: The rectum below the peritoneal reflection was dissected circumferentially up to a level 2 cm above the anal verge . LASo group: The rectum below the peritoneal reflection was minimally mobilized (within 1 cm of the peritoneal reflection). Following laparoscopic dissection, the ports were left in situ, and the position was adjusted for transanal dissection of the remaining rectum.

laparoscopic-assisted Soave (LASo)

Procedure

Transanal endorectal procedure was conducted according to the standard technique described by De la Torre-Mondragon and Ortega-Salgado [12]. A circular incision was made in the mucosa, and mucosectomy was performed. The muscle sleeve was cut, connecting the two dissection planes circularly . After keeping the muscular cuff as short as possible, a longitudinal incision was made posteriorly. Then, the bowel was extracted, and the anastomosis was performed as described above.

Primary outcomes

  1. postoperative bowel function score

    Time frame: 2 years

    This assessment evaluated the ability to hold back defecation, the ability to feel or report the urge to defecate, the frequency of defecation, soiling accidents, constipation, and social issues. Most items are scored on a 0-3 scale, while defecation frequency is scored 1-2, resulting in a maximum total score of 20. A higher score indicates better bowel function, with Scores ranged from 17-20 (excellent), 12-16 (good), 9-11 (fair), and less than 8 (poor)

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2025
Registry last updated
Sep 29, 2025

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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