Hirschprung's DiseaseNCT07410286
Comparative Research Between Swenson and Soave Operations for Pediatric Patients Who Have Hirschsprung Disease
A study testing Swenson operation includes resection of the aganglionic segment and anastomosis with full thickness layer above the dentate. and Soave procedure: includes resection of the aganglionic segment and anastomosis with submucosal thickness layer above the dentate. in people with Hirschprung's Disease and Constipation, run by Ahmed Aouf at 1 site in Egypt.
Trial summary
Hirschsprung's disease is characterized by a lack of enteric nervous system ganglion cells (aganglionosis) in a variable extent of distal bowel. It is the commonest congenital bowel motility disorder and affected neonates usually present with distal intestinal obstruction in the first few days of life. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Hirschprung's Disease, Constipation, RECTUM
- What is being tested?
- Swenson operation includes resection of the aganglionic segment and anastomosis with full thickness layer above the dentate. and Soave procedure: includes resection of the aganglionic segment and anastomosis with submucosal thickness layer above the dentate.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients who are present with Hirschsprung disease.
Who cannot join
- • Patients with severe systemic disease making anesthesia or surgery prohibitively risky (American society of Anesthesiologists (ASA) class IV.
- Children who underwent secondary surgery from the study.
- Total colonic aganglionosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University Hospitals
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516
About this study
Official title: Comparative Study Between Swenson and Soave Techniques for Cases With Hirschsprung Disease
Hirschsprung's disease is characterized by a lack of enteric nervous system ganglion cells (aganglionosis) in a variable extent of distal bowel. It is the commonest congenital bowel motility disorder and affected neonates usually present with distal intestinal obstruction in the first few days of life. Despite the common underlying pathology of Hirschsprung disease, it has varying presentations. Infants classically present with delayed passage of meconium, feeding intolerance, and bilious emesis. In fact, 90% of children with Hirschsprung will not have passage of stool within the first 24 h of life. Neonates and infants can also present with abdominal distension, failure to thrive, enterocolitis, or bowel perforation.
Hirschsprung's disease is characterized by a variable length of distal colonic aganglionosis. In approximately 80% of cases, it is short-segment, and only involves the rectosigmoid colon. Less commonly, it can extend proximal to the sigmoid colon (15%), include the entire colon (total colonic aganglionosis, 5%), or rarely, the entire intestine (total intestinal aganglionosis). The principles of the operation are to remove the aganglionic colon and connect the normally innervated bowel just above the anus, at a level which prevents further functional obstruction, but at the same time preserves fecal continence.
Read more
The surgical treatment of Hirschsprung's disease has evolved from the historical three-stage procedure to a single-stage technique. Since then, multiple series reported its safety, efficacy, and feasibility in the management of HSCR in the neonatal period. Swenson and Bill, Soave, and Duhamel are the most common procedures for Hirschsprung's disease. However, there is a heated debate about which technique gives the best short- and long-term outcomes. There are many surgical approaches to Hirschsprung's disease, including the transabdominal approach (TAB) and transanal endorectal pull-through (TERPT). The TAB includes 4 types: the Swenson, Duhamel, Rehbein, and Soave procedures. Both the Swenson and the Soave procedures have been adapted as transanal approaches.
Transanal access is based on the traditional surgical techniques performed previously in abdominal approach. This type of surgery is used for the treatment of small children. Transanal endorectal pull-through method performed with transanal access is characterized by low invasiveness of surgery and good results of treatment.
The Swenson procedure involves the removal of the entire affected site and end-to-end anastomosis of the normal colonic anal canal. In the Soave procedure, physiological saline is injected into the rectum after cutting through the rectal muscle layer in a circular manner, while keeping the mucosa intact to the dentate line level.
- Conditions
- Hirschprung's Disease, Constipation, RECTUM
- Being tested
- Swenson operation includes resection of the aganglionic segment and anastomosis with full thickness layer above the dentate., Soave procedure: includes resection of the aganglionic segment and anastomosis with submucosal thickness layer above the dentate.
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swenson operation includes resection of the aganglionic segment and anastomosis with full thickness layer above the dentate.Procedure or surgery
The Swenson operation: The patient is placed in either the prone or lithotomy position and full-thickness dissection is started 1 cm above the dentate line until ganglionated bowel is encountered. Fine silk suturing is performed circumferentially at the level of that point which would be used for traction for the distal end. Another circumferential suture was performed parallel 0.5 cm distances above the original one and used for traction for the proximal intestines. The full-thickness rectal wall is truncated between the above two circumferential sutures with cautery, avoiding damaging adjacent tissues when the abdominal cavity is open. The full thickness of rectum and sigmoid colon is mobilized out though the anus and the mesenteric vessels are carefully dissected and ligatured. The colon is divided until a few centimeters above the most proximal normal site. The distal rectum is pulled eversion and is dissected anteriorly 2.5-3.5 cm above the dentate line.
Soave procedure: includes resection of the aganglionic segment and anastomosis with submucosal thickness layer above the dentate.Procedure or surgery
For the operation, the patient is placed in a prone position with the pelvis elevated. As a first step to the transanal mucosectomy of the rectum, the anal canal is exposed, and a circumferential incision is made 1cm above the dentate line in the rectal mucosa. Using blunt dissection, a submucosal plane is developed placing multiple 5-0 silk traction sutures in the mucosa to facilitate its separation from the muscular wall. The submucosal plane is extended 6 cm.
The next step is to prepare the muscular sleeve through which the normoganglionic colon would be pulled. At the same site at which mucosectomy is finished, a complete incision on the rectal muscle is made to reach into the perirectal tissue. To liberate the muscular sleeve, perirectal tissue is dissected, and smooth muscle fibers of the rectum are divided circumferentially. Through this procedure, the muscular sleeve could be liberated and returned to its original position.
| Study group | Role | What they receive |
|---|---|---|
| Swenson procedure | Active comparator | full-thickness dissection is started 1 cm above the dentate line Receives: Procedure: Swenson operation includes resection of the aganglionic segment and anastomosis with full thickness layer above the dentate. |
| Soave procedure | Active comparator | circumferential incision is made 1cm above the dentate line in the rectal mucosa. Using blunt dissection, a submucosal plane is developed Receives: Procedure: Soave procedure: includes resection of the aganglionic segment and anastomosis with submucosal thickness layer above the dentate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time.
Time taken to perform the surgery completely.
Measured: From enrollment to the 6 months postoperatively.
Secondary outcomes (1)
Frequency of defecation
Number of fecal motions every day
Measured: From the time of enrollment to the 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Nov 2023
- Primary completion1 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hirschprung's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Aouf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Aouf, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410286
- Sponsor's protocol ID
- KFSIRB200-622
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information included data of complicated cases.
Publications
Dave, A., Allukian, M., Dickie, B. (2022). Hirschsprung Disease. In: Mattei, P. (eds) Fundamentals of Pediatric Surgery. Springer, Cham. https://doi.org/10.1007/978-3-031-07524-7_72
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Swenson and Soave Techniques for Cases With Hirschsprung Disease
- ClinicalTrials.gov ID
- NCT07410286
- Acronym / sponsor ID
- KFSIRB200-622
- Conditions
- Hirschprung's Disease, Constipation, RECTUM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ahmed AoufUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hirschsprung's disease is characterized by a lack of enteric nervous system ganglion cells (aganglionosis) in a variable extent of distal bowel. It is the commonest congenital bowel motility disorder and affected neonates usually present with distal intestinal obstruction in the first few days of life. Despite the common underlying pathology of Hirschsprung disease, it has varying presentations. Infants classically present with delayed passage of meconium, feeding intolerance, and bilious emesis. In fact, 90% of children with Hirschsprung will not have passage of stool within the first 24 h of life. Neonates and infants can also present with abdominal distension, failure to thrive, enterocolitis, or bowel perforation.
Hirschsprung's disease is characterized by a variable length of distal colonic aganglionosis. In approximately 80% of cases, it is short-segment, and only involves the rectosigmoid colon. Less commonly, it can extend proximal to the sigmoid colon (15%), include the entire colon (total colonic aganglionosis, 5%), or rarely, the entire intestine (total intestinal aganglionosis). The principles of the operation are to remove the aganglionic colon and connect the normally innervated bowel just above the anus, at a level which prevents further functional obstruction, but at the same time preserves fecal continence.
The surgical treatment of Hirschsprung's disease has evolved from the historical three-stage procedure to a single-stage technique. Since then, multiple series reported its safety, efficacy, and feasibility in the management of HSCR in the neonatal period. Swenson and Bill, Soave, and Duhamel are the most common procedures for Hirschsprung's disease. However, there is a heated debate about which technique gives the best short- and long-term outcomes. There are many surgical approaches to Hirschsprung's disease, including the transabdominal approach (TAB) and transanal endorectal pull-through (TERPT). The TAB includes 4 types: the Swenson, Duhamel, Rehbein, and Soave procedures. Both the Swenson and the Soave procedures have been adapted as transanal approaches.
Transanal access is based on the traditional surgical techniques performed previously in abdominal approach. This type of surgery is used for the treatment of small children. Transanal endorectal pull-through method performed with transanal access is characterized by low invasiveness of surgery and good results of treatment.
The Swenson procedure involves the removal of the entire affected site and end-to-end anastomosis of the normal colonic anal canal. In the Soave procedure, physiological saline is injected into the rectum after cutting through the rectal muscle layer in a circular manner, while keeping the mucosa intact to the dentate line level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swenson procedure | Active comparator | Procedure: Swenson operation includes resection of the aganglionic segment and anastomosis with full thickness layer above the dentate.full-thickness dissection is started 1 cm above the dentate line |
| Soave procedure | Active comparator | Procedure: Soave procedure: includes resection of the aganglionic segment and anastomosis with submucosal thickness layer above the dentate.circumferential incision is made 1cm above the dentate line in the rectal mucosa. Using blunt dissection, a submucosal plane is developed |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients who are present with Hirschsprung disease.
Key exclusion criteria (3 listed)
- • Patients with severe systemic disease making anesthesia or surgery prohibitively risky (American society of Anesthesiologists (ASA) class IV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swenson operation includes resection of the aganglionic segment and anastomosis with full thickness layer above the dentate.The Swenson operation: The patient is placed in either the prone or lithotomy position and full-thickness dissection is started 1 cm above the dentate line until ganglionated bowel is encountered. Fine silk suturing is performed circumferentially at the level of that point which would be used for traction for the distal end. Another circumferential suture was performed parallel 0.5 cm distances above the original one and used for traction for the proximal intestines. The full-thickness rectal wall is truncated between the above two circumferential sutures with cautery, avoiding damaging adjacent tissues when the abdominal cavity is open. The full thickness of rectum and sigmoid colon is mobilized out though the anus and the mesenteric vessels are carefully dissected and ligatured. The colon is divided until a few centimeters above the most proximal normal site. The distal rectum is pulled eversion and is dissected anteriorly 2.5-3.5 cm above the dentate line. | Procedure or surgery | Swenson procedure |
| Soave procedure: includes resection of the aganglionic segment and anastomosis with submucosal thickness layer above the dentate.For the operation, the patient is placed in a prone position with the pelvis elevated. As a first step to the transanal mucosectomy of the rectum, the anal canal is exposed, and a circumferential incision is made 1cm above the dentate line in the rectal mucosa. Using blunt dissection, a submucosal plane is developed placing multiple 5-0 silk traction sutures in the mucosa to facilitate its separation from the muscular wall. The submucosal plane is extended 6 cm. The next step is to prepare the muscular sleeve through which the normoganglionic colon would be pulled. At the same site at which mucosectomy is finished, a complete incision on the rectal muscle is made to reach into the perirectal tissue. To liberate the muscular sleeve, perirectal tissue is dissected, and smooth muscle fibers of the rectum are divided circumferentially. Through this procedure, the muscular sleeve could be liberated and returned to its original position. | Procedure or surgery | Soave procedure |
Primary outcome
Operative time.
Time frame: From enrollment to the 6 months postoperatively.
Time taken to perform the surgery completely.
1 secondary outcome
Frequency of defecation
Time frame: From the time of enrollment to the 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- BackgroundDave, A., Allukian, M., Dickie, B. (2022). Hirschsprung Disease. In: Mattei, P. (eds) Fundamentals of Pediatric Surgery. Springer, Cham. https://doi.org/10.1007/978-3-031-07524-7_72
- Individual participant dataSharing planned: No. The information included data of complicated cases.
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Enrolling by invitationObservational study
Long-Term Health Outcomes in Children Born With Hirschsprung's Disease and Anorectal Malformations at the Colorectal Centre of Excellence in Quebec
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swenson operation includes resection of the aganglionic segment and anastomosis with full thickness layer above the dentate. and Soave procedure: includes resection of the aganglionic segment and anastomosis with submucosal thickness layer above the dentate. in people with Hirschprung's Disease and Constipation, run by Ahmed Aouf at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time. (time frame: From enrollment to the 6 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07410286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.