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

NCT07186647 | Completed Phase 4

• 1 other identifier: Ped. -Surg.-77MED.-Research-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hirschsprung Disease

Keywords

Hirschsprung Disease; Laparoscopy; Swenson; Soave; Pediatrics

Outcome Measures

Primary Outcomes (1)

• postoperative bowel function score

  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)

  2 years

Study Arms (2)

Group A

ACTIVE COMPARATOR

20 patients with HD

Procedure: laparoscopic-assisted Swenson-like (LASwL)

Group B

ACTIVE COMPARATOR

20 patients with HD

Procedure: laparoscopic-assisted Soave (LASo)

Interventions

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.

Group A

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.

Group B

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

pediatric surgery departments- Al-Azhar University Hospitals

Cairo, Egypt

Location

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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: A prospective, randomized study

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 22, 2025
• Study Start: September 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

EG (1)