ClinicalTrials.gg
Status unknownNCT03269812Updated Sep 1, 2017

Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease

An interventional study of laparoscopic assisted pull-through oeration in Hirschsprung Disease, sponsored by Assiut University. Status unknown. Open to participants aged 6 Months to 36 Months. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
6 Months to 36 Months
Sex
All
01

Study summary

To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung disease.

Read the detailed description

Hirschsprung,s disease (HD) is a relatively common cause of intestinal obstruction in the newborn[1,2], The main goal in the treatment of patients with Hirschsprung,s disease is to resect the aganglionic segment and pull down the Normo-ganglionic bowel[3]. With the introduction of minimally invasive surgery, classic pull-through techniques were modified and improved with laparoscopy, because of the obvious advantages of laparoscopic-assisted pull-through operations in form of reduced pain and improved cosmoses this approach has gained much popularity[4,5].

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Conditions studied

  • Hirschsprung Disease

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03

In context

Hirschsprung Disease

63 studies on the registry are indexed under Hirschsprung Disease; 24 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 32 interventional studies indexed under Hirschsprung Disease.

Browse Hirschsprung Disease studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 36 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age from 6months to 3 years.
  2. Both sexes.
  3. Classic and long segment Hirshsprung.
  4. Total a ganglionic colon.
  5. Hirshsprung disease with leveling colostomy

Exclusion criteria

Exclusion Criteria:

  1. Patients \<6 months and >3 years.
  2. Short and Ultra-short Hirshsprung.
  3. Recurrent cases of Hirshsprung.
  4. Other of laparoscopy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    laparoscopic operated group

    Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,

    Procedure: laparoscopic assisted pull-through oeration

  • Experimental
    non laparoscopic operated group

    Under general anesthesia ,abdominal exploration ,removal of a ganglionic part by soav ,duhamel procedures and trans-anal pull through procedures.

    Procedure: laparoscopic assisted pull-through oeration

Interventions

  • Procedurelaparoscopic assisted pull-through oeration

    Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,

06

What researchers measure

Primary outcomes

  1. Constipation

    persistace of inablilty to pass stool even after operation and treatment,it is physiological parameter and assisted by asking the mothers of patients about the bowel habits.

    Time frame: from one to three months after operation

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Tomuschat C, Zimmer J, Puri P. Laparoscopic-assisted pull-through operation for Hirschsprung's disease: a systematic review and meta-analysis. Pediatr Surg Int. 2016 Aug;32(8):751-7. doi: 10.1007/s00383-016-3910-5. Epub 2016 Jul 1. PubMed 27369964 ↗
  • Taguchi T, Obata S, Ieiri S. Current status of Hirschsprung's disease: based on a nationwide survey of Japan. Pediatr Surg Int. 2017 Apr;33(4):497-504. doi: 10.1007/s00383-016-4054-3. Epub 2017 Jan 5. PubMed 28058486 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2017; primary completion for Sep 2019, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2017
First posted
Sep 1, 2017
StartEst.
Sep 1, 2017
Primary completionEst.
Sep 1, 2019
CompletionEst.
Oct 1, 2019
Last update
Sep 1, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03269812
Lead sponsor
Assiut University
Responsible party
Mohammed Hamada Takrouney (Principal investigator and Assistant lecturer of pediatric surgery, Assiut University) — Principal investigator
First posted
Sep 1, 2017
Start date
Sep 1, 2017 (estimated)
Primary completion
Sep 1, 2019 (estimated)
Completion
Oct 1, 2019 (estimated)
Last update
Sep 1, 2017

Study contacts

Mohammed Hamada Takrouney
Contact
m.takrouney1988@gmail.com
+201009321033
Ibrahim Ali Ibrahim
Contact
Dr.ibrahimali@yahoo.com
+201005801291

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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