## Protocol Section
### Identification Module
**NCT ID:** NCT06419998

**Brief Title:** Transanal Versus Laparoscopic-assisted Transanal Through in the Management of Hirschsprung's Disease

**Official Title:** One Stage Transanal Versus One Stage Laparoscopic-assisted Transanal Endorectal Pull-through in the Management of Hirschsprung's Disease in Pediatric Age Group; A Retrospective Study.

#### Organization Study ID Info
**ID:** 0306356
#### Organization
**Class:** NETWORK
**Full Name:** Egyptian Biomedical Research Network
### Status Module
#### Completion Date
**Date:** 2023-12-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NETWORK

**Name:** Egyptian Biomedical Research Network

#### Responsible Party

**Investigator Affiliation:** Egyptian Biomedical Research Network

**Investigator Full Name:** Ahmed Elrouby

**Investigator Title:** Associate Professor of pediatric Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) in pediatric patients presented with Hirschsprung's Disease between 3 months and 18 years old.

The main questions our study aims to answer are:

* Does post-operative continence differs between the two groups?
* Does post-operative constipation differs between the two groups?
* Does post-operative soiling differs between the two groups
* Does post-operative enterocolitis differs between the two groups?
* Do post-operative complications differ between the two groups? If there is a comparison group: Researchers will compare between pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) to see if there is a difference in post-operative continence, constipation, soiling, enterocolitis or complications.

Participants will be divided into two groups; 40 patients will be treated by TAERPT and included in Group A and 30 patients will be treated by LAERPT and included in Group B.

**Detailed Description:** Introduction: One-stage treatment of endorectal pull-through for Hirschsprung's disease could be approached through a complete transanal approach or with the assistance of laparoscopy. Our study aims to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT). Material \& methods: This retrospective study included 70 pediatric patients presented with Hirschsprung's Disease to Elshatby University Hospital. 40 patients were treated by TAERPT and included in Group A and 30 patients were treated by LAERPT and included in Group B. The two groups were compared as regards the operative data as well as the post-operative outcomes including the time of passage of stools, time of tolerating oral feeding, the duration of hospital stay, and the development of any early postoperative complications. Also, the number of bowel habits, constipation, enterocolitis, abdominal distension, anastomotic stricture, and continence were assessed.

### Conditions Module

**Conditions:**

- Pediatric Disorder

- Hirschprung's Disease

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 70

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Pediatric patients presented with Hirschsprung's disease treated by pure transanal endorectal pull-through (TAERPT)

**Intervention Names:**

- Procedure: Group A: Pure transanal endorectal pull-through (TAERPT)

**Label:** Group A

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Pediatric patients presented with Hirschsprung's disease treated by laparoscopic-assistance endorectal pull-through (LAERPT)

**Intervention Names:**

- Procedure: Group B: Laparoscopic-assistance endorectal pull-through (LAERPT)

**Label:** Group B

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A

**Description:** Patients of Group A will be treated totally by pure transanal endorectal pull-through without the assistance of laparoscopy

**Name:** Group A: Pure transanal endorectal pull-through (TAERPT)

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Group B

**Description:** Patients of Group B will be treated transanal endorectal pull-through but with the assistance of laparoscopy

**Name:** Group B: Laparoscopic-assistance endorectal pull-through (LAERPT)

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The two groups will be compared according to post-operative continence whether continent or incontinent by using Abbreviated Baylor Social Continence Scale. the sore ranges from 0 to 24 with the minimum score revealing an excellent result and the highest score revealing the worst result. (Excellent = 0-5, Good = 7-12, Fair = 13-18, Poor = 19-24)

**Measure:** Post-operative continence

**Time Frame:** One post-operative year

**Description:** The two groups will be compared according to post-operative constipation whether present or not

**Measure:** Post-operative constipation

**Time Frame:** One post-operative year

**Description:** The two groups will be compared according to post-operative soiling whether present or not

**Measure:** Post-operative soiling

**Time Frame:** One post-operative year

**Description:** The two groups will be compared according to post-operative enterocolitis whether present or not

**Measure:** Post-operative enterocolitis

**Time Frame:** One post-operative year

**Description:** The two groups will be compared according to post-operative complications whether present or not

**Measure:** Post-operative complications

**Time Frame:** One post-operative year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

\* Pediatric patients with age range between 3 months and 18 years old presented with Hirschsprung's Disease who were confirmed to have this condition by contrast enema and/or rectal biopsy.

Exclusion Criteria:

* Patients with previous colostomy.

**Maximum Age:** 18 Years

**Minimum Age:** 3 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Alexandria

**Country:** Egypt

**Facility:** Ahmed El Rouby

**Zip:** 12345

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004065

- Term: Digestive System Abnormalities

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008531

- Term: Megacolon

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9703

- Name: Hirschsprung Disease

- Relevance: HIGH

- As Found: Hirschsprung Disease

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M7254

- Name: Digestive System Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11514

- Name: Megacolon

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2802

- Name: Hirschsprung Disease

- Relevance: HIGH

- As Found: Hirschsprung Disease

### Condition Browse Module - Meshes

- ID: D000006627

- Term: Hirschsprung Disease

### Misc Info Module

- Version Holder: 2024-05-31
