Hirschsprung DiseaseNCT06880666
Minimally Invasive Surgical Intervention for Hirschsprung Disease
A study testing Minimally invasive laparoscopic pull-through surgery in people with Hirschsprung Disease, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
Trial summary
Hirschsprung's disease (HD) is one of the most common congenital conditions, with a global incidence of 1/5000 newborns; the prevalence in the Vietnamese population is even higher. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hirschsprung Disease
- What is being tested?
- Minimally invasive laparoscopic pull-through surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2020to 1 Mar 2025
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: From 1 to 28 days old
- Diagnosis: Hirschsprung disease was diagnosed based on clinical presentation, intraoperative frozen section biopsy, and postoperative histopathological findings showing absence of ganglion cells.
- Surgical Approach: Patients underwent SILEP through a single periumbilical incision, with no additional abdominal incisions. All surgeries were conducted by the same team, and postoperative care was provided according to a standardized protocol.
- Parents or guardians provided consent to participate in the study and committed to following the scheduled follow-up visits.
Who cannot join
- Patients exhibiting severe HAEC, bowel obstruction, or peritonitis at the time of operation
- Those with a history of failed Hirschsprung disease surgery, prior abdominal operations, or colostomy
- Individuals with contraindications to laparoscopic procedures, such as bleeding disorders or significant congenital heart defects
- Cases where parents or legal guardians refused consent for study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Surgical Intervention for Hirschsprung Disease: A Prospective Study on Efficacy and Long-term Functional Outcomes for Neonatal Patients
Hirschsprung's disease (HD) is one of the most common congenital conditions, with a global incidence of 1/5000 newborns; the prevalence in the Vietnamese population is even higher. The absence of enteric ganglia in the distal bowel causes intestinal obstruction and delayed meconium passage in newborns, as well as failure of normal defecation later in life. If left untreated, HD can lead to life complications such as enterocolitis and even death. Standard treatment involves surgical resection of the affected bowel segment, with minimally invasive laparoscopic techniques offering reduced postoperative complications, shorter hospital stays, and faster recovery compared to open surgery. Since 2012, the National Children Hospital has been the first institution in Vietnam to routinely use the minimally invasive surgical approach for HD. However, due to a lack of research funding and patients' financial constraints to travel to post-operative treatment centers, there has yet to be a publication addressing the long-term outcomes and associated abnormalities of all patients treated with SILS. Thus, the purpose of this study is to report on the safety, efficacy, and long-term functional outcomes and cosmesis results of minimally invasive surgeries performed on HD neonatal patients at The National Children's Hospital from 2020 to 2021, thus optimize surgical management and improve patient outcomes in a lower-middle-income country setting.
Read the detailed description
Hirschsprung's disease (HD) is one of the most common congenital disorders affecting the gastrointestinal tract, with a global incidence of approximately 1 in 5,000 live births. However, studies suggest that the prevalence is notably higher in the Vietnamese population. The condition arises due to the absence of enteric ganglion cells in the distal colon, leading to a functional obstruction that prevents normal bowel motility. This defect results in delayed meconium passage in newborns, severe constipation, abdominal distension, and feeding intolerance. If left untreated, HD can progress to life-threatening complications such as Hirschsprung-associated enterocolitis (HAEC), bowel perforation, sepsis, and even death.
Surgical intervention remains the mainstay of treatment for HD, with the goal of resecting the aganglionic bowel segment and restoring normal intestinal function. Traditionally, open pull-through procedures were the standard approach, but advancements in minimally invasive surgery (MIS) have led to the widespread adoption of laparoscopic techniques. Georgeson's traditional three-port laparoscopic rectal pull-through technique, first introduced in 1995, has been widely used as the standard treatment for HD. The first case of single-incision laparoscopic assisted rectal pull-through (SILS) surgery for HD was published in 2010, in which six patients who underwent SILS all had positive outcomes and excellent cosmesis. Compared to conventional open surgery, laparoscopic approaches offer several benefits, including reduced postoperative pain, fewer wound-related complications, shorter hospital stays, improved cosmetic outcomes, and faster overall recovery. Despite the promising outcomes of minimally invasive surgical intervention, 15 years after the first reported case, only a few articles (a total of 9 articles reported in Pubmed) have been published to evaluate SILS in HD.
Since 2012, the Vietnam National Children's Hospital (NCH) has been a pioneer in the routine use of the minimally invasive surgical technique for the treatment of Hirschsprung's disease in Vietnam. However, despite over a decade of experience with this method, research on long-term outcomes in Vietnamese patients remains scarce. A major challenge has been the limited availability of research funding and the financial difficulties faced by many families, which prevent regular postoperative follow-ups and comprehensive long-term studies. As a result, there is currently no published data evaluating the long-term safety, efficacy, and potential postoperative complications associated with minimally invasive intervention for HD in this specific patient population.
The primary objective of this study is to bridge this knowledge gap by systematically analyzing the outcomes of pediatric patients who underwent minimally invasive surgical intervention for Hirschsprung's disease at NCH between 2020 and 2021. The study aims to assess key factors such as perioperative outcomes, postoperative bowel function, the incidence of complications such as anastomotic stricture or incontinence, associated abnormalities/ comorbidities, cosmesis, and quality of life improvements. By providing robust clinical evidence, this research will contribute to optimizing surgical management strategies for Hirschsprung's disease in resource-limited settings, ultimately improving patient outcomes and guiding future surgical practices in Vietnam and other LMICs.
- Conditions
- Hirschsprung Disease
- Being tested
- Minimally invasive laparoscopic pull-through surgery
- Keywords
- Aganglionic bowel, Minimally invasive, Laparoscopic, Single incision, Pediatric, Hirschsprung
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive laparoscopic pull-through surgeryProcedure or surgery
Conventional laparoscopic pull-through (CLP) surgery utilizes 3-5 small abdominal incisions for the placement of trocars, allowing the insertion of a laparoscopic camera and surgical instruments. After establishing pneumoperitoneum, the aganglionic segment is identified, and the colon is mobilized by dividing the lateral attachments using laparoscopic energy devices. The rectal dissection is performed circumferentially down to the level of the pelvic floor while preserving the mesenteric blood supply. A transanal approach is then used to complete the dissection, pull the mobilized bowel through the anus, and resect the aganglionic segment. A coloanal anastomosis is created, typically with absorbable sutures. Single-incision laparoscopic pull-through (SILS) follows the same principles but is performed through a single umbilical incision using a multi-port device; instruments and a camera are inserted through the same access point.
| Study group | Role | What they receive |
|---|---|---|
| MIS-Treated Hirschsprung Patients (2020-2024) | Experimental | Neonatal patients diagnosed with Hirschsprung's Disease, admitted to the National Children's Hospital between 2020 to 2021, and underwent Single incision laparoscopic surgery Receives: Procedure: Minimally invasive laparoscopic pull-through surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Blood Loss
The amount of blood lost during surgery will be measured in milliliters (mL) by collecting blood from suction devices, counting soaked surgical sponges, and assessing any other visible loss
Measured: Perioperative
Conversion to open surgery
The proportion of cases in which single-incision laparoscopic surgery (SILS) could not be optimally completed and required conversion to open surgical techniques. Conversion may be necessitated by factors such as poor visualization, uncontrolled bleeding, adhesions, or patient-specific anatomical challenges. The outcome will be measured as the percentage of procedures requiring conversion during the perioperative period.
Measured: Perioperative
Operative time
Total duration of the surgical procedure from skin incision to closure, measured in minutes.
Measured: Perioperative
Mortality and severe morbidity
The incidence of mortality and severe postoperative complications following single-incision laparoscopic pull-through surgery. Severe morbidity includes life-threatening conditions such as sepsis, multi-organ failure, other major complications requiring intensive medical intervention, and death. This outcome will be assessed throughout the study period.
Measured: Through study completion, an average of 4 years
Early postoperative complications
The incidence of early postoperative complications, including but not limited to bowel obstruction, surgical site infections, and Hirschsprung-associated enterocolitis (HAEC). Additional complications such as anastomotic leakage, prolonged ileus, or unexpected reoperation will also be monitored.
Measured: Up to 8 weeks post-operation
Rintala score
The Rintala Score assesses postoperative bowel function in pediatric Hirschsprung disease (HD) patients, ranging from 0 to 20. It evaluates stool frequency, incontinence, constipation, and social continence. Scores of 18-20 indicate excellent function with normal bowel habits and no incontinence. Scores of 10-17 suggest moderate function, with occasional issues like constipation or minor incontinence. Scores below 10 reflect poor function, often requiring medical or surgical intervention.
Measured: Through study completion, an average of 4 years
Manchester Scar Scale
The Manchester Scar Scale (MSS) evaluates the aesthetic and physical characteristics of scars, scoring from 4 to 28. It assesses scar color, contour, texture, distortion, and patient discomfort. Lower scores (4-8) indicate minimal scarring with good cosmetic outcomes. Moderate scores (9-18) suggest noticeable but acceptable scars with some textural or color irregularities. Higher scores (19-28) reflect severe scarring, often associated with significant discoloration, contour defects, or functional impairment.
Measured: Through study completion, an average of 4 years
Secondary outcomes (1)
Associated conditions
Incidence of any medical or surgical conditions identified before or after laparoscopic pull-through surgery, assessed through clinical evaluation, imaging, and diagnostic testing.
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Jan 2020
- Primary completion31 Dec 2021
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hirschsprung 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Children's Hospital, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Thanh Quang, National Children's Hospital, Vietnam
- Investigators
- Quang T Nguyen, M.D., Principal investigator, Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880666
- Sponsor's protocol ID
- HS50/BB - HĐĐĐ
- Status last verified
- Jun 2025
- First submitted
- 2 Mar 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puri P, Nakamura H. Epidemiology and Clinical Characteristics of Hirschsprung's Disease. In: Hirschsprung's Disease and Allied Disorders
Mayo Clinic. Hirschsprung's disease - Symptoms and causes 2021
Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
PubMed 20596233Ure BM, Rintala RJ, Holschneider AM. Scoring postoperative results. Anorectal Malformations Child Embryol Diagnosis, Surg Treat Follow. 2006;351-9.
Amiel J, Lyonnet S. Hirschsprung disease, associated syndromes, and genetics: a review. J Med Genet. 2001 Nov;38(11):729-39. doi: 10.1136/jmg.38.11.729.
PubMed 11694544Liu, M., Fang, Y., Zhang, B., Lin, Y., Li, O., Bai, J., … & Wu, D. (2020). Laparoscopic-assisted soave operation for the treatment of hirschsprung disease in children: 5 years of experience.. https://doi.org/10.21203/rs.3.rs-18886/v1
LÊ NH. ĐÁNH GIÁ KẾT QUẢ PHẪU THUẬT BỆNH GIÃN ĐẠI TRỰC TRÀNG BẨM SINH Ở NGƯỜI LỚN TẠI BỆNH VIỆN VIỆT ĐỨC. 2020
Georgeson KE, Robertson DJ. Laparoscopic-assisted approaches for the definitive surgery for Hirschsprung's disease. Semin Pediatr Surg. 2004 Nov;13(4):256-62. doi: 10.1053/j.sempedsurg.2004.10.013.
PubMed 15660319Zimmermann P, Martynov I, Perger L, Scholz S, Lacher M. 20 Years of Single-Incision-Pediatric-Endoscopic-Surgery: A Survey on Opinion and Experience Among International Pediatric Endosurgery Group Members. J Laparoendosc Adv Surg Tech A. 2021 Mar;31(3):348-354. doi: 10.1089/lap.2020.0797. Epub 2020 Dec 31.
PubMed 33395367Xia X, Li N, Wei J, Zhang W, Yu D, Zhu T, Feng J. Single-incision laparoscopic versus conventional laparoscopic surgery for Hirschsprung's disease: A comparison of medium-term outcomes. J Pediatr Surg. 2016 Mar;51(3):440-3. doi: 10.1016/j.jpedsurg.2015.10.051. Epub 2015 Oct 24.
PubMed 26611332Nguyen LT, Nguyen AT, Nguyen QT, Tran QA, Bui HD, Pham HD. Suspension sutures facilitate single-incision laparoscopic-assisted rectal pull-through for Hirschsprung disease. BMC Surg. 2021 May 31;21(1):274. doi: 10.1186/s12893-021-01260-w.
PubMed 34059040Muensterer OJ, Chong A, Hansen EN, Georgeson KE. Single-incision laparoscopic endorectal pull-through (SILEP) for hirschsprung disease. J Gastrointest Surg. 2010 Dec;14(12):1950-4. doi: 10.1007/s11605-010-1299-3. Epub 2010 Aug 18.
PubMed 20717739
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgical Intervention for Hirschsprung Disease: A Prospective Study on Efficacy and Long-term Functional Outcomes for Neonatal Patients
- ClinicalTrials.gov ID
- NCT06880666
- Acronym / sponsor ID
- HS50/BB - HĐĐĐ
- Conditions
- Hirschsprung Disease
- Keywords
- Aganglionic bowel, Minimally invasive, Laparoscopic, Single incision, Pediatric, Hirschsprung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Children's Hospital, VietnamUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 18 Mar 2025 (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 (HD) is one of the most common congenital conditions, with a global incidence of 1/5000 newborns; the prevalence in the Vietnamese population is even higher. The absence of enteric ganglia in the distal bowel causes intestinal obstruction and delayed meconium passage in newborns, as well as failure of normal defecation later in life. If left untreated, HD can lead to life complications such as enterocolitis and even death. Standard treatment involves surgical resection of the affected bowel segment, with minimally invasive laparoscopic techniques offering reduced postoperative complications, shorter hospital stays, and faster recovery compared to open surgery. Since 2012, the National Children Hospital has been the first institution in Vietnam to routinely use the minimally invasive surgical approach for HD. However, due to a lack of research funding and patients' financial constraints to travel to post-operative treatment centers, there has yet to be a publication addressing the long-term outcomes and associated abnormalities of all patients treated with SILS. Thus, the purpose of this study is to report on the safety, efficacy, and long-term functional outcomes and cosmesis results of minimally invasive surgeries performed on HD neonatal patients at The National Children's Hospital from 2020 to 2021, thus optimize surgical management and improve patient outcomes in a lower-middle-income country setting.
Detailed description
Hirschsprung's disease (HD) is one of the most common congenital disorders affecting the gastrointestinal tract, with a global incidence of approximately 1 in 5,000 live births. However, studies suggest that the prevalence is notably higher in the Vietnamese population. The condition arises due to the absence of enteric ganglion cells in the distal colon, leading to a functional obstruction that prevents normal bowel motility. This defect results in delayed meconium passage in newborns, severe constipation, abdominal distension, and feeding intolerance. If left untreated, HD can progress to life-threatening complications such as Hirschsprung-associated enterocolitis (HAEC), bowel perforation, sepsis, and even death.
Surgical intervention remains the mainstay of treatment for HD, with the goal of resecting the aganglionic bowel segment and restoring normal intestinal function. Traditionally, open pull-through procedures were the standard approach, but advancements in minimally invasive surgery (MIS) have led to the widespread adoption of laparoscopic techniques. Georgeson's traditional three-port laparoscopic rectal pull-through technique, first introduced in 1995, has been widely used as the standard treatment for HD. The first case of single-incision laparoscopic assisted rectal pull-through (SILS) surgery for HD was published in 2010, in which six patients who underwent SILS all had positive outcomes and excellent cosmesis. Compared to conventional open surgery, laparoscopic approaches offer several benefits, including reduced postoperative pain, fewer wound-related complications, shorter hospital stays, improved cosmetic outcomes, and faster overall recovery. Despite the promising outcomes of minimally invasive surgical intervention, 15 years after the first reported case, only a few articles (a total of 9 articles reported in Pubmed) have been published to evaluate SILS in HD.
Since 2012, the Vietnam National Children's Hospital (NCH) has been a pioneer in the routine use of the minimally invasive surgical technique for the treatment of Hirschsprung's disease in Vietnam. However, despite over a decade of experience with this method, research on long-term outcomes in Vietnamese patients remains scarce. A major challenge has been the limited availability of research funding and the financial difficulties faced by many families, which prevent regular postoperative follow-ups and comprehensive long-term studies. As a result, there is currently no published data evaluating the long-term safety, efficacy, and potential postoperative complications associated with minimally invasive intervention for HD in this specific patient population.
The primary objective of this study is to bridge this knowledge gap by systematically analyzing the outcomes of pediatric patients who underwent minimally invasive surgical intervention for Hirschsprung's disease at NCH between 2020 and 2021. The study aims to assess key factors such as perioperative outcomes, postoperative bowel function, the incidence of complications such as anastomotic stricture or incontinence, associated abnormalities/ comorbidities, cosmesis, and quality of life improvements. By providing robust clinical evidence, this research will contribute to optimizing surgical management strategies for Hirschsprung's disease in resource-limited settings, ultimately improving patient outcomes and guiding future surgical practices in Vietnam and other LMICs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIS-Treated Hirschsprung Patients (2020-2024) | Experimental | Procedure: Minimally invasive laparoscopic pull-through surgeryNeonatal patients diagnosed with Hirschsprung's Disease, admitted to the National Children's Hospital between 2020 to 2021, and underwent Single incision laparoscopic surgery |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: From 1 to 28 days old
- Diagnosis: Hirschsprung disease was diagnosed based on clinical presentation, intraoperative frozen section biopsy, and postoperative histopathological findings showing absence of ganglion cells.
- Surgical Approach: Patients underwent SILEP through a single periumbilical incision, with no additional abdominal incisions. All surgeries were conducted by the same team, and postoperative care was provided according to a standardized protocol.
- Parents or guardians provided consent to participate in the study and committed to following the scheduled follow-up visits.
Key exclusion criteria (4 listed)
- Patients exhibiting severe HAEC, bowel obstruction, or peritonitis at the time of operation
- Those with a history of failed Hirschsprung disease surgery, prior abdominal operations, or colostomy
- Individuals with contraindications to laparoscopic procedures, such as bleeding disorders or significant congenital heart defects
- Cases where parents or legal guardians refused consent for study participation
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 |
|---|---|---|
| Minimally invasive laparoscopic pull-through surgeryConventional laparoscopic pull-through (CLP) surgery utilizes 3-5 small abdominal incisions for the placement of trocars, allowing the insertion of a laparoscopic camera and surgical instruments. After establishing pneumoperitoneum, the aganglionic segment is identified, and the colon is mobilized by dividing the lateral attachments using laparoscopic energy devices. The rectal dissection is performed circumferentially down to the level of the pelvic floor while preserving the mesenteric blood supply. A transanal approach is then used to complete the dissection, pull the mobilized bowel through the anus, and resect the aganglionic segment. A coloanal anastomosis is created, typically with absorbable sutures. Single-incision laparoscopic pull-through (SILS) follows the same principles but is performed through a single umbilical incision using a multi-port device; instruments and a camera are inserted through the same access point. | Procedure or surgery | MIS-Treated Hirschsprung Patients (2020-2024) |
Primary outcome
Volume of Blood Loss
Time frame: Perioperative
The amount of blood lost during surgery will be measured in milliliters (mL) by collecting blood from suction devices, counting soaked surgical sponges, and assessing any other visible loss
Conversion to open surgery
Time frame: Perioperative
The proportion of cases in which single-incision laparoscopic surgery (SILS) could not be optimally completed and required conversion to open surgical techniques. Conversion may be necessitated by factors such as poor visualization, uncontrolled bleeding, adhesions, or patient-specific anatomical challenges. The outcome will be measured as the percentage of procedures requiring conversion during the perioperative period.
Operative time
Time frame: Perioperative
Total duration of the surgical procedure from skin incision to closure, measured in minutes.
Mortality and severe morbidity
Time frame: Through study completion, an average of 4 years
The incidence of mortality and severe postoperative complications following single-incision laparoscopic pull-through surgery. Severe morbidity includes life-threatening conditions such as sepsis, multi-organ failure, other major complications requiring intensive medical intervention, and death. This outcome will be assessed throughout the study period.
Early postoperative complications
Time frame: Up to 8 weeks post-operation
The incidence of early postoperative complications, including but not limited to bowel obstruction, surgical site infections, and Hirschsprung-associated enterocolitis (HAEC). Additional complications such as anastomotic leakage, prolonged ileus, or unexpected reoperation will also be monitored.
Rintala score
Time frame: Through study completion, an average of 4 years
The Rintala Score assesses postoperative bowel function in pediatric Hirschsprung disease (HD) patients, ranging from 0 to 20. It evaluates stool frequency, incontinence, constipation, and social continence. Scores of 18-20 indicate excellent function with normal bowel habits and no incontinence. Scores of 10-17 suggest moderate function, with occasional issues like constipation or minor incontinence. Scores below 10 reflect poor function, often requiring medical or surgical intervention.
Manchester Scar Scale
Time frame: Through study completion, an average of 4 years
The Manchester Scar Scale (MSS) evaluates the aesthetic and physical characteristics of scars, scoring from 4 to 28. It assesses scar color, contour, texture, distortion, and patient discomfort. Lower scores (4-8) indicate minimal scarring with good cosmetic outcomes. Moderate scores (9-18) suggest noticeable but acceptable scars with some textural or color irregularities. Higher scores (19-28) reflect severe scarring, often associated with significant discoloration, contour defects, or functional impairment.
1 secondary outcome
Associated conditions
Time frame: Through study completion, an average of 4 years
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 15 Jun 2025.
- BackgroundPuri P, Nakamura H. Epidemiology and Clinical Characteristics of Hirschsprung's Disease. In: Hirschsprung's Disease and Allied Disorders
- BackgroundMayo Clinic. Hirschsprung's disease - Symptoms and causes 2021
- Background: PubMed 20596233Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.
- BackgroundUre BM, Rintala RJ, Holschneider AM. Scoring postoperative results. Anorectal Malformations Child Embryol Diagnosis, Surg Treat Follow. 2006;351-9.
- Background: PubMed 11694544Amiel J, Lyonnet S. Hirschsprung disease, associated syndromes, and genetics: a review. J Med Genet. 2001 Nov;38(11):729-39. doi: 10.1136/jmg.38.11.729.
- Results publicationLiu, M., Fang, Y., Zhang, B., Lin, Y., Li, O., Bai, J., … & Wu, D. (2020). Laparoscopic-assisted soave operation for the treatment of hirschsprung disease in children: 5 years of experience.. https://doi.org/10.21203/rs.3.rs-18886/v1
- Results publicationLÊ NH. ĐÁNH GIÁ KẾT QUẢ PHẪU THUẬT BỆNH GIÃN ĐẠI TRỰC TRÀNG BẨM SINH Ở NGƯỜI LỚN TẠI BỆNH VIỆN VIỆT ĐỨC. 2020
- Results publication: PubMed 15660319Georgeson KE, Robertson DJ. Laparoscopic-assisted approaches for the definitive surgery for Hirschsprung's disease. Semin Pediatr Surg. 2004 Nov;13(4):256-62. doi: 10.1053/j.sempedsurg.2004.10.013.
- Results publication: PubMed 33395367Zimmermann P, Martynov I, Perger L, Scholz S, Lacher M. 20 Years of Single-Incision-Pediatric-Endoscopic-Surgery: A Survey on Opinion and Experience Among International Pediatric Endosurgery Group Members. J Laparoendosc Adv Surg Tech A. 2021 Mar;31(3):348-354. doi: 10.1089/lap.2020.0797. Epub 2020 Dec 31.
- Results publication: PubMed 26611332Xia X, Li N, Wei J, Zhang W, Yu D, Zhu T, Feng J. Single-incision laparoscopic versus conventional laparoscopic surgery for Hirschsprung's disease: A comparison of medium-term outcomes. J Pediatr Surg. 2016 Mar;51(3):440-3. doi: 10.1016/j.jpedsurg.2015.10.051. Epub 2015 Oct 24.
- Results publication: PubMed 34059040Nguyen LT, Nguyen AT, Nguyen QT, Tran QA, Bui HD, Pham HD. Suspension sutures facilitate single-incision laparoscopic-assisted rectal pull-through for Hirschsprung disease. BMC Surg. 2021 May 31;21(1):274. doi: 10.1186/s12893-021-01260-w.
- Results publication: PubMed 20717739Muensterer OJ, Chong A, Hansen EN, Georgeson KE. Single-incision laparoscopic endorectal pull-through (SILEP) for hirschsprung disease. J Gastrointest Surg. 2010 Dec;14(12):1950-4. doi: 10.1007/s11605-010-1299-3. Epub 2010 Aug 18.
- Individual participant dataSharing planned: No
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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.
Quang T Nguyen, M.D. principal investigator
Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive laparoscopic pull-through surgery in people with Hirschsprung Disease, run by National Children's Hospital, Vietnam at 1 site in Vietnam.
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 4 inclusion and 4 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 15 Jun 2025. 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 Vietnam. 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?
Volume of Blood Loss (time frame: Perioperative). The study lists 7 primary outcomes in all. 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 NCT06880666, which also lists 12 linked publications.
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 15 Jun 2025.