IntussusceptionNCT06351163
Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study
An observational study of Intussusception, run by National Children's Hospital, Vietnam at 2 sites in Vietnam.
Trial summary
Intussusception is the primary cause of intestinal obstruction in children aged 3 months to 5 years, leading to significant morbidity and mortality rates. Most cases involve the ileocolic region and can often be resolved through air enema, with a success rate of up to 95%. Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Intussusception
- What is being tested?
- Laparoscopic reduction and Transumbilical mini-open reduction
- Type of treatment
- Surgery or procedure
- How many people
- 181 participants
- Where
- 2 sitesVietnam
- Study dates
- Jan 2016to Mar 2024
- Phase
- Observational
- 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 2 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: From January 2016 to December 2020, a group of pediatric patients displaying clinical manifestations suggestive of intussusception, coupled with positive ultrasound results, were admitted to the emergency department of the Vietnam National Children's Hospital. The patients underwent pneumatic reduction up to three attempts, with LAP being indicated if air enema reduction failed.
Who may be able to join
- Patients diagnosed with idiopathic intussusception, admitted to the National Children's Hospital between January 2016 and December 2020, exhibiting clinical signs and symptoms consistent with intussusception, and confirmed by ultrasound.
- Fluoroscopy-guided pneumatic reduction was performed, allowing a maximum of three attempts.
- Patients unresponsive to pneumatic reduction underwent laparoscopic reduction (LAP).
- If LAP failed to manage the intussusceptum, conversion to transumbilical mini-open reduction (MOR) was initiated.
- Patients deemed unsuitable for air enema reduction due to a grossly distended abdomen or compromised cardiopulmonary function, making them unlikely to tolerate pneumoperitoneum, were also directed towards MOR.
- Patients with a history of previous intussusception episodes requiring reduction.
Show all 9Show fewer
- Patients displaying clinical instability with signs of peritonitis or intestinal perforation requiring conventional laparotomy.
- Patients presenting with pathologic lead points.
- Patients who had complications, such as perforation, during pneumatic reduction.
Who cannot join
- Patients in critical condition or suspected of bowel perforation and peritonitis
- Patients who did not meet the criteria for air enema reduction due to significant abdominal distension or compromised cardiopulmonary function
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
The National Hospital of Pediatrics
Hanoi
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi
About this study
Official title: Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study on the Long-Term Outcome
Intussusception is the primary cause of intestinal obstruction in children aged 3 months to 5 years, leading to significant morbidity and mortality rates. Most cases involve the ileocolic region and can often be resolved through air enema, with a success rate of up to 95%. Surgical intervention becomes necessary if pneumatic reduction fails or is not recommended. Traditionally, manual reduction required a large incision on the right side of the abdomen. However, the advancement of minimally invasive techniques, such as the laparoscopic approach (LAP), has become increasingly popular for managing intussusception. LAP offers benefits such as reduced surgical trauma and shorter operative times compared to open procedures. Nevertheless, the adoption of LAP remains controversial due to challenges like limited working space in children and variability in the affected bowel segment. This study aims to investigate the safety and feasibility of LAP and mini-open reduction (MOR) techniques in treating idiopathic intussusception in pediatric patients.
Read the detailed description
Intussusception, the leading cause of intestinal obstruction in children aged 3 months to 5 years, significantly impacts morbidity and mortality rates. Most cases involve the ileocolic region and are typically amenable to resolution via air enema, achieving success rates of up to 95%. Surgical intervention becomes necessary in cases where pneumatic reduction fails or is contraindicated. Historically, the manual reduction required a substantial right-sided transverse incision. However, the advancement of minimally invasive approaches in pediatric surgery, particularly the laparoscopic approach (LAP), has gained traction in managing intussusception. LAP offers the advantages of decreased surgical trauma and shorter operative durations compared to open procedures. Nevertheless, the adoption of laparoscopic intervention for intussusception remains contentious due to challenges such as limited operative space in pediatric patients and variability in the affected bowel segment, impeding widespread acceptance. This study aims to investigate the safety and feasibility of laparoscopic (LAP) and mini-open reduction (MOR) techniques in managing idiopathic intussusception in pediatric patients.
- Conditions
- Intussusception
- Being tested
- Laparoscopic reduction, Transumbilical mini-open reduction
- Keywords
- Intussusception, Minimally-invasive, Laparoscopic, Children, Pediatric, Air enema, Pneumatic reduction
- Medical subject headings
- Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic reductionProcedure or surgery
A 1cm longitudinal transumbilical incision was made to insert a 5mm trocar for laparoscope placement. CO2 was injected at 10mmHg and a flow rate of 3L. Two 5-mm working trocars were inserted in the lower right and left abdomen under direct visualization, along with two grasping forceps. The ascending colon was manipulated to locate the intussusception mass. Atraumatic graspers were alternately utilized on the ascending colon to mobilize the intussusceptum, pushing it downward towards the cecum. The first visible part of the terminal ileum was grasped and pulled outward and downward, along with its mesentery, using the right grasper, while the left grasper pulled the intussusceptum's neck in the opposite direction. If resistance was encountered, the terminal ileum could be held with the left hand while the right grasper widened the intussusceptum's neck. After reduction, the intestines were examined for necrosis and possible lead points, followed by routine appendectomy and ileopexy.
Transumbilical mini-open reductionProcedure or surgery
If laparoscopic reduction alone was unsuccessful or if bowel resection was required, the intussusceptum was fixed with grasping forceps and brought to the umbilicus for MOR. A 2cm transumbilical incision was created, and a skin retractor was inserted. The underlying fascia was longitudinally extended upward and downward along the linea alba. Upon division of the peritoneum, the actual opening could be expanded up to 5cm, while maintaining the skin incision at 2cm. If the initial incision site proved insufficient for exploration, lateral division of the rectus muscle around the umbilicus on both sides could be performed without cutting the skin, thereby enlarging the surgical field. Manual reduction of the intussusceptum was subsequently carried out, along with bowel resection and anastomosis as indicated.
| Study group | Role | What they receive |
|---|---|---|
| Intussusception | Pediatric patients exhibiting clinical signs and symptoms of intussusception between January 2016 and December 2020 that fit in with the inclusion criteria of the study. Receives: Procedure: Laparoscopic reduction; Procedure: Transumbilical mini-open reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating time
The average operating time (minutes) recorded between the two operating techniques (MOR or LAP)
Measured: through study completion (5 years)
Intraoperative complications
Instances of complications occurred during both operating techniques (MOR or LAP)
Measured: through study completion (5 years)
Immediate postoperative complications
Instances of complication occurred immediately subsequent to the operation utilizing either MOR or LAP
Measured: through study completion (5 years)
Time to feed
The average amount of time (days) for the patient to tolerate feeding post-operation (MOR or LAP)
Measured: through study completion (5 years)
Hospital stays
The average amount of time (days) for the patient to get discharged post-operation (MOR or LAP)
Measured: through study completion (5 years)
Recurrence rate
Instances when signs or symptoms of intussusception re-occurred after receiving treatment via operation (MOR or LAP)
Measured: through study completion (5 years)
Long-term complication rate
Instances of complications occurred post-operation found on subsequent follow-ups for patients treated with either MOR or LAP
Measured: through study completion (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study startJan 2016
- Primary completionDec 2020
- Study completionMar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for IntussusceptionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Children's Hospital, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Vinmec Research Institute of Stem Cell and Gene Technology
- Responsible party
- Principal investigator, Nguyen Thanh Quang, National Children's Hospital, Vietnam
- Investigators
- Quang T Nguyen, Principal investigator, Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351163
- Sponsor's protocol ID
- 1451_03/BVNTW-VNCSKTE
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang PC, Duh YC, Fu YW, Hsu YJ, Wei CH. Single-incision laparoscopic surgery for idiopathic intussusception in children: Comparison with conventional laparoscopy. J Pediatr Surg. 2019 Aug;54(8):1604-1608. doi: 10.1016/j.jpedsurg.2018.07.010. Epub 2018 Jul 21.
PubMed 30121127Bailey KA, Wales PW, Gerstle JT. Laparoscopic versus open reduction of intussusception in children: a single-institution comparative experience. J Pediatr Surg. 2007 May;42(5):845-8. doi: 10.1016/j.jpedsurg.2006.12.037.
PubMed 17502196Attoun MA, Albalawi SMD, Ayoub A, Alnasser AK, Alkaram EH, Khubrani FA, Alzahrani KJ, Alatawi KA, Almutairi N, Alnami AG. The Management of Intussusception: A Systematic Review. Cureus. 2023 Nov 27;15(11):e49481. doi: 10.7759/cureus.49481. eCollection 2023 Nov.
PubMed 38152810Cuckow PM, Slater RD, Najmaldin AS. Intussusception treated laparoscopically after failed air enema reduction. Surg Endosc. 1996 Jun;10(6):671-2. doi: 10.1007/BF00188527.
PubMed 8662412Kelley-Quon LI, Arthur LG, Williams RF, Goldin AB, St Peter SD, Beres AL, Hu YY, Renaud EJ, Ricca R, Slidell MB, Taylor A, Smith CA, Miniati D, Sola JE, Valusek P, Berman L, Raval MV, Gosain A, Dellinger MB, Somme S, Downard CD, McAteer JP, Kawaguchi A. Management of intussusception in children: A systematic review. J Pediatr Surg. 2021 Mar;56(3):587-596. doi: 10.1016/j.jpedsurg.2020.09.055. Epub 2020 Oct 6.
PubMed 33158508Wu P, Huang P, Fu Y, Lv Y, Feng S, Lou Y. Laparoscopic versus Open Reduction of Intussusception in Infants and Children: A Systematic Review and Meta-analysis. Eur J Pediatr Surg. 2022 Dec;32(6):469-476. doi: 10.1055/s-0042-1749437. Epub 2022 Jun 10.
PubMed 35688449Delgado-Miguel C, Garcia A, Delgado B, Munoz-Serrano A, Miguel-Ferrero M, Camps JI, Lopez-Santamaria M, Martinez L. Incidental appendectomy in surgical treatment of ileocolic intussusception in children. Is it safe to perform? Cir Pediatr. 2022 Oct 1;35(4):165-171. doi: 10.54847/cp.2022.04.16. English, Spanish.
PubMed 36217786Liu T, Wu Y, Xu W, Liu J, Sheng Q, Lv Z. A retrospective study about incidental appendectomy during the laparoscopic treatment of intussusception. Front Pediatr. 2022 Sep 6;10:966839. doi: 10.3389/fped.2022.966839. eCollection 2022.
PubMed 36147812Zhang Y, Wang Y, Zhang Y, Hu X, Li B, Ming G. Laparoscopic Ileopexy Versus Laparoscopic Simple Reduction in Children with Multiple Recurrences of Ileocolic Intussusception: A Single-Institution Retrospective Cohort Study. J Laparoendosc Adv Surg Tech A. 2020 May;30(5):576-580. doi: 10.1089/lap.2019.0641. Epub 2020 Apr 2.
PubMed 32240037Loukas M, Pellerin M, Kimball Z, de la Garza-Jordan J, Tubbs RS, Jordan R. Intussusception: an anatomical perspective with review of the literature. Clin Anat. 2011 Jul;24(5):552-61. doi: 10.1002/ca.21099. Epub 2011 Jan 25.
PubMed 21268121Li B, Sun CX, Chen WB, Zhang FN. Laparoscopic Ileocolic Pexy as Preventive Treatment Alternative for Ileocolic Intussusception With Multiple Recurrences in Children. Surg Laparosc Endosc Percutan Tech. 2018 Oct;28(5):314-317. doi: 10.1097/SLE.0000000000000564.
PubMed 30067586Yang J, Wang G, Gao J, Zhong X, Gao K, Liu Q, Nan G, Yan C, Chen G, Lu P, Guo C. Liberal surgical laparoscopy reduction for acute intussusception: experience from a tertiary pediatric institute. Sci Rep. 2024 Jan 3;14(1):457. doi: 10.1038/s41598-023-50493-7.
PubMed 38172223Zhao J, Sun J, Li D, Xu WJ. Laparoscopic versus open reduction of idiopathic intussusception in children: an updated institutional experience. BMC Pediatr. 2022 Jan 17;22(1):44. doi: 10.1186/s12887-022-03112-9.
PubMed 35038989Li SM, Wu XY, Luo CF, Yu LJ. Laparoscopic approach for managing intussusception in children: Analysis of 65 cases. World J Clin Cases. 2022 Jan 21;10(3):830-839. doi: 10.12998/wjcc.v10.i3.830.
PubMed 35127899Wei CH, Fu YW, Wang NL, Du YC, Sheu JC. Laparoscopy versus open surgery for idiopathic intussusception in children. Surg Endosc. 2015 Mar;29(3):668-72. doi: 10.1007/s00464-014-3717-1. Epub 2014 Jul 19.
PubMed 25037726
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study on the Long-Term Outcome
- ClinicalTrials.gov ID
- NCT06351163
- Acronym / sponsor ID
- 1451_03/BVNTW-VNCSKTE
- Conditions
- Intussusception
- Keywords
- Intussusception, Minimally-invasive, Laparoscopic, Children, Pediatric, Air enema, Pneumatic reduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- National Children's Hospital, VietnamUniversity, hospital or other
- Collaborators
- Vinmec Research Institute of Stem Cell and Gene Technology
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Mar 2024 (actual)
- First posted
- 8 Apr 2024 (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.
Intussusception is the primary cause of intestinal obstruction in children aged 3 months to 5 years, leading to significant morbidity and mortality rates. Most cases involve the ileocolic region and can often be resolved through air enema, with a success rate of up to 95%. Surgical intervention becomes necessary if pneumatic reduction fails or is not recommended. Traditionally, manual reduction required a large incision on the right side of the abdomen. However, the advancement of minimally invasive techniques, such as the laparoscopic approach (LAP), has become increasingly popular for managing intussusception. LAP offers benefits such as reduced surgical trauma and shorter operative times compared to open procedures. Nevertheless, the adoption of LAP remains controversial due to challenges like limited working space in children and variability in the affected bowel segment. This study aims to investigate the safety and feasibility of LAP and mini-open reduction (MOR) techniques in treating idiopathic intussusception in pediatric patients.
Detailed description
Intussusception, the leading cause of intestinal obstruction in children aged 3 months to 5 years, significantly impacts morbidity and mortality rates. Most cases involve the ileocolic region and are typically amenable to resolution via air enema, achieving success rates of up to 95%. Surgical intervention becomes necessary in cases where pneumatic reduction fails or is contraindicated. Historically, the manual reduction required a substantial right-sided transverse incision. However, the advancement of minimally invasive approaches in pediatric surgery, particularly the laparoscopic approach (LAP), has gained traction in managing intussusception. LAP offers the advantages of decreased surgical trauma and shorter operative durations compared to open procedures. Nevertheless, the adoption of laparoscopic intervention for intussusception remains contentious due to challenges such as limited operative space in pediatric patients and variability in the affected bowel segment, impeding widespread acceptance. This study aims to investigate the safety and feasibility of laparoscopic (LAP) and mini-open reduction (MOR) techniques in managing idiopathic intussusception in pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intussusception | – | Procedure: Laparoscopic reduction, Procedure: Transumbilical mini-open reductionPediatric patients exhibiting clinical signs and symptoms of intussusception between January 2016 and December 2020 that fit in with the inclusion criteria of the study. |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- From January 2016 to December 2020, a group of pediatric patients displaying clinical manifestations suggestive of intussusception, coupled with positive ultrasound results, were admitted to the emergency department of the Vietnam National Children's Hospital. The patients underwent pneumatic reduction up to three attempts, with LAP being indicated if air enema reduction failed.
Key inclusion criteria (9 listed)
- Patients diagnosed with idiopathic intussusception, admitted to the National Children's Hospital between January 2016 and December 2020, exhibiting clinical signs and symptoms consistent with intussusception, and confirmed by ultrasound.
- Fluoroscopy-guided pneumatic reduction was performed, allowing a maximum of three attempts.
- Patients unresponsive to pneumatic reduction underwent laparoscopic reduction (LAP).
- If LAP failed to manage the intussusceptum, conversion to transumbilical mini-open reduction (MOR) was initiated.
- Patients deemed unsuitable for air enema reduction due to a grossly distended abdomen or compromised cardiopulmonary function, making them unlikely to tolerate pneumoperitoneum, were also directed towards MOR.
Key exclusion criteria (2 listed)
- Patients in critical condition or suspected of bowel perforation and peritonitis
- Patients who did not meet the criteria for air enema reduction due to significant abdominal distension or compromised cardiopulmonary function
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 |
|---|---|---|
| Laparoscopic reductionA 1cm longitudinal transumbilical incision was made to insert a 5mm trocar for laparoscope placement. CO2 was injected at 10mmHg and a flow rate of 3L. Two 5-mm working trocars were inserted in the lower right and left abdomen under direct visualization, along with two grasping forceps. The ascending colon was manipulated to locate the intussusception mass. Atraumatic graspers were alternately utilized on the ascending colon to mobilize the intussusceptum, pushing it downward towards the cecum. The first visible part of the terminal ileum was grasped and pulled outward and downward, along with its mesentery, using the right grasper, while the left grasper pulled the intussusceptum's neck in the opposite direction. If resistance was encountered, the terminal ileum could be held with the left hand while the right grasper widened the intussusceptum's neck. After reduction, the intestines were examined for necrosis and possible lead points, followed by routine appendectomy and ileopexy. | Procedure or surgery | Intussusception |
| Transumbilical mini-open reductionIf laparoscopic reduction alone was unsuccessful or if bowel resection was required, the intussusceptum was fixed with grasping forceps and brought to the umbilicus for MOR. A 2cm transumbilical incision was created, and a skin retractor was inserted. The underlying fascia was longitudinally extended upward and downward along the linea alba. Upon division of the peritoneum, the actual opening could be expanded up to 5cm, while maintaining the skin incision at 2cm. If the initial incision site proved insufficient for exploration, lateral division of the rectus muscle around the umbilicus on both sides could be performed without cutting the skin, thereby enlarging the surgical field. Manual reduction of the intussusceptum was subsequently carried out, along with bowel resection and anastomosis as indicated. | Procedure or surgery | Intussusception |
Primary outcome
Operating time
Time frame: through study completion (5 years)
The average operating time (minutes) recorded between the two operating techniques (MOR or LAP)
Intraoperative complications
Time frame: through study completion (5 years)
Instances of complications occurred during both operating techniques (MOR or LAP)
Immediate postoperative complications
Time frame: through study completion (5 years)
Instances of complication occurred immediately subsequent to the operation utilizing either MOR or LAP
Time to feed
Time frame: through study completion (5 years)
The average amount of time (days) for the patient to tolerate feeding post-operation (MOR or LAP)
Hospital stays
Time frame: through study completion (5 years)
The average amount of time (days) for the patient to get discharged post-operation (MOR or LAP)
Recurrence rate
Time frame: through study completion (5 years)
Instances when signs or symptoms of intussusception re-occurred after receiving treatment via operation (MOR or LAP)
Long-term complication rate
Time frame: through study completion (5 years)
Instances of complications occurred post-operation found on subsequent follow-ups for patients treated with either MOR or LAP
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 8 Apr 2024.
- Background: PubMed 30121127Chang PC, Duh YC, Fu YW, Hsu YJ, Wei CH. Single-incision laparoscopic surgery for idiopathic intussusception in children: Comparison with conventional laparoscopy. J Pediatr Surg. 2019 Aug;54(8):1604-1608. doi: 10.1016/j.jpedsurg.2018.07.010. Epub 2018 Jul 21.
- Background: PubMed 17502196Bailey KA, Wales PW, Gerstle JT. Laparoscopic versus open reduction of intussusception in children: a single-institution comparative experience. J Pediatr Surg. 2007 May;42(5):845-8. doi: 10.1016/j.jpedsurg.2006.12.037.
- Background: PubMed 38152810Attoun MA, Albalawi SMD, Ayoub A, Alnasser AK, Alkaram EH, Khubrani FA, Alzahrani KJ, Alatawi KA, Almutairi N, Alnami AG. The Management of Intussusception: A Systematic Review. Cureus. 2023 Nov 27;15(11):e49481. doi: 10.7759/cureus.49481. eCollection 2023 Nov.
- Background: PubMed 8662412Cuckow PM, Slater RD, Najmaldin AS. Intussusception treated laparoscopically after failed air enema reduction. Surg Endosc. 1996 Jun;10(6):671-2. doi: 10.1007/BF00188527.
- Background: PubMed 33158508Kelley-Quon LI, Arthur LG, Williams RF, Goldin AB, St Peter SD, Beres AL, Hu YY, Renaud EJ, Ricca R, Slidell MB, Taylor A, Smith CA, Miniati D, Sola JE, Valusek P, Berman L, Raval MV, Gosain A, Dellinger MB, Somme S, Downard CD, McAteer JP, Kawaguchi A. Management of intussusception in children: A systematic review. J Pediatr Surg. 2021 Mar;56(3):587-596. doi: 10.1016/j.jpedsurg.2020.09.055. Epub 2020 Oct 6.
- Background: PubMed 35688449Wu P, Huang P, Fu Y, Lv Y, Feng S, Lou Y. Laparoscopic versus Open Reduction of Intussusception in Infants and Children: A Systematic Review and Meta-analysis. Eur J Pediatr Surg. 2022 Dec;32(6):469-476. doi: 10.1055/s-0042-1749437. Epub 2022 Jun 10.
- Background: PubMed 36217786Delgado-Miguel C, Garcia A, Delgado B, Munoz-Serrano A, Miguel-Ferrero M, Camps JI, Lopez-Santamaria M, Martinez L. Incidental appendectomy in surgical treatment of ileocolic intussusception in children. Is it safe to perform? Cir Pediatr. 2022 Oct 1;35(4):165-171. doi: 10.54847/cp.2022.04.16. English, Spanish.
- Background: PubMed 36147812Liu T, Wu Y, Xu W, Liu J, Sheng Q, Lv Z. A retrospective study about incidental appendectomy during the laparoscopic treatment of intussusception. Front Pediatr. 2022 Sep 6;10:966839. doi: 10.3389/fped.2022.966839. eCollection 2022.
- Background: PubMed 32240037Zhang Y, Wang Y, Zhang Y, Hu X, Li B, Ming G. Laparoscopic Ileopexy Versus Laparoscopic Simple Reduction in Children with Multiple Recurrences of Ileocolic Intussusception: A Single-Institution Retrospective Cohort Study. J Laparoendosc Adv Surg Tech A. 2020 May;30(5):576-580. doi: 10.1089/lap.2019.0641. Epub 2020 Apr 2.
- Background: PubMed 21268121Loukas M, Pellerin M, Kimball Z, de la Garza-Jordan J, Tubbs RS, Jordan R. Intussusception: an anatomical perspective with review of the literature. Clin Anat. 2011 Jul;24(5):552-61. doi: 10.1002/ca.21099. Epub 2011 Jan 25.
- Background: PubMed 30067586Li B, Sun CX, Chen WB, Zhang FN. Laparoscopic Ileocolic Pexy as Preventive Treatment Alternative for Ileocolic Intussusception With Multiple Recurrences in Children. Surg Laparosc Endosc Percutan Tech. 2018 Oct;28(5):314-317. doi: 10.1097/SLE.0000000000000564.
- Background: PubMed 38172223Yang J, Wang G, Gao J, Zhong X, Gao K, Liu Q, Nan G, Yan C, Chen G, Lu P, Guo C. Liberal surgical laparoscopy reduction for acute intussusception: experience from a tertiary pediatric institute. Sci Rep. 2024 Jan 3;14(1):457. doi: 10.1038/s41598-023-50493-7.
- 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 principal investigator
Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intussusception, run by National Children's Hospital, Vietnam at 2 sites 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 9 inclusion and 2 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 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Operating time (time frame: through study completion (5 years)). 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 NCT06351163, which also lists 22 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 8 Apr 2024.