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

NCT ID: NCT07186647

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-08-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Hirschsprung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, randomized study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group A

20 patients with HD

Group Type ACTIVE_COMPARATOR

laparoscopic-assisted Swenson-like (LASwL)

Intervention Type 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 B

20 patients with HD

Group Type ACTIVE_COMPARATOR

laparoscopic-assisted Soave (LASo)

Intervention Type 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.

Interventions

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laparoscopic-assisted Swenson-like (LASwL)

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.

Intervention Type PROCEDURE

laparoscopic-assisted Soave (LASo)

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abdelmaboud

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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pediatric surgery departments- Al-Azhar University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ped. -Surg.-77MED.-Research-00

Identifier Type: -

Identifier Source: org_study_id

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