Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508726005103 Date of Registration: 14/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Laparoscopic-Assisted Hydrostatic Reduction for Pediatric Intussusception
Official scientific title Laparoscopic-Assisted Hydrostatic Reduction of Pediatric Intussusception: A Prospective Study from a Single Tertiary Center
Brief summary describing the background and objectives of the trial Intussusception is a leading cause of bowel obstruction in the pediatric population. Its diagnosis is usually based on clinical features and is confirmed either by Ultrasonography (U/S) or contrast enema, Computed Tomography (CT) scan is considered on rare occasions. Approximately 85% of these cases are reduced via pneumatic or hydrostatic enema. Radiological guided reduction of intussusception (air or saline enema) is considered the first line of treatment with an average success rate 80% (range 40%-90%). Surgical intervention is required for the cases with failed enema reduction, hemodynamic instability and/or peritonitis. This typically involves 10 to 20% of cases. Traditionally, unsuccessful radiological reduction has been followed by laparotomy. Later, the introduction of laparoscopy in pediatric surgical field has added another dimension to the management of intussusception. The use of laparoscopy has increased significantly in the past 20 years. It was initially utilized as a diagnostic modality after failed hydrostatic reduction of intussusception and then was used as a definitive treatment. Available reports claim advantages of laparoscopic over the open approach, such as less postoperative pain, reduced wound complications, minimal scarring, shorter hospital stay and an earlier return to normal activities. The purpose of this study was to evaluate the benefit of laparoscopy in guiding hydrostatic reduction of intussusception and evaluation of the reduced mass with regard to perforation, ischemic signs or any other pathology.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2023
Actual trial start date 01/01/2023
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 53
Actual target sample size (number of participants) 53
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Laparoscopic Assisted Hydrostatic Reduction of Pediatric Intussusception Not applicable Not applicable Laparoscopic-Assisted Hydrostatic Reduction (LAHR) Technique: The patient was positioned supine, and then after induction of general anaesthesia, the patient is prepared for hydrostatic reduction before sterilization and draping. A large-bore (24 French) Foley catheter was placed into the anus and was advanced a few centimeters to ensure positioning above the anal sphincters well within the rectum. The Foley catheter balloon was inflated by 30 cc saline. The catheter was pulled back gently against the anorectal junction to maintain a seal and taped in place, secured to the buttocks. A bag of warm saline was hanged above the patient by about 3 feet. Urinary catheter was inserted to ensure empty urinary bladder. Sterilization and draping were done and then a 5 mm optic trocar was inserted through an umbilical incision using the open method then insufflation at pressure 8 to 10 mmHg was done. A 5 mm 30-degree telescope was introduced into the peritoneal cavity. The first thing was to determine the site of intussusception mass. Other two 5 mm trocars were placed in the left lower quadrant and suprapubic area after confirming existing intussusception and the position may be changed according to the site of the mass. The first step was to identify the leading edge of the intussusceptum and hydrostatic reduction was started. In some cases, two atraumatic graspers were used to squeeze the most distal part of the intussusceptum slowly and gently back towards the cecum as much as possible. After reduction, careful inspection was performed for assessment of the reduced bowel mass and rule out any sign of ischemia, necrosis, perforation or the existence of a pathologic lead point as inflamed appendix or any mass. When laparoscopic reduction failed or reduced bowel was gangrenous, right colon mobilization was done and the umbilical incision was extended about 1 to 2 cm and getting the bowel through it for resection and anastomosis. Intra-abdominal drain inserted if needed. 53
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria were all pediatric intussusception cases. Exclusion criteria were unstable general condition, contraindication of laparoscopic surgery (e.g. cardiac disease), patients with marked abdominal distension, and those with signs of peritonitis. Infant: 0 Month(s)-12 Month(s),Preschool Child: 2 Year-5 Year 8 Month(s) 14 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/01/2023 Research ethical committee Faculty of medicine Tanta university Tanta Egypt
Ethics Committee Address
Street address City Postal code Country
El Geish st. Tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome was the success of LAHR, which was defined as complete reduction of the intussusception mass under laparoscopic visualization and restoration of normal bowel appearance and continuity, without the need for conversion to mini-laparotomy or bowel resection. A successful case also included the absence of intraoperative findings requiring resection (e.g., perforation, necrosis, or tumor). complete reduction of the intussusception mass under laparoscopic visualization and restoration of normal bowel appearance and continuity
Secondary Outcome Secondary outcomes included postoperative complications. • Postoperative infection was defined by the presence of purulent fluid in the surgical drain or intraperitoneal space, supported by systemic signs such as fever >38°C or elevated white cell count, or by ultrasound, and treated with appropriate antibiotics and supportive measures. • Postoperative ileus was diagnosed based on clinical signs of abdominal distension, delayed return of bowel function (no flatus or stool >48 hours), and radiologic evidence of air-fluid levels. • Wound infection was defined as localized erythema, warmth, and/or purulent discharge at the trocar or mini-laparotomy sites, requiring local or systemic antibiotic therapy. Discharge from hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospitals El Geish st. Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Shehata El Geish st. Tanta 31257 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor None none none Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Shehata mohamedshehata81@hotmail.com 00201114330114 El Geish st.
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Associate professor of pediatric surgery Tanta University Tanta Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elhaddad Dr.ahmed_elhaddad@yahoo.com 00201002821898 El Geish st.
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Associate professor of pediatric surgery Tanta University Tanta Egypt
Role Name Email Phone Street address
Scientific Enquiries Youssef Aboshosha Youssefaboshosha@gmail.com 00201092970729 El Geish st.
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Assistant lecturer of Pediatric Surgery Tanta University Tanta Egypt
Role Name Email Phone Street address
Public Enquiries Abdelmotaleb Ebeid abdelmoteleb.ibrahim@med.tanta.edu.eg 00201007975755 El Geish
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Professor of Pediatric Surgery Faculty of Medicine Tanta University Tanta Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures) will be shared, beginning 9 months and ending 36 months following article publication to researchers who provide a methodologically sound proposal. Study Protocol within 12 months Statistical analysis was done by SPSS v28 (IBM Inc., Armonk, NY, USA). Shapiro-Wilks test and histograms were used to evaluate the normality of the distribution of data. Quantitative parametric data were presented as mean and standard deviation (SD). Quantitative non-parametric data were presented as median and interquartile range (IQR). Qualitative variables were presented as frequency and percentage (%). As this was a descriptive prospective study evaluating outcomes in a single-arm cohort of patients undergoing LAHR after failed USGHR, inferential statistical testing such as p-values or confidence intervals was not applied. Data were summarized using means, standard deviations, medians, and percentages as appropriate. Comparative inferential statistics were not feasible due to the absence of a control group.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 08/08/2025 to add background The purpose of this study was to evaluate the benefit of laparoscopy in guiding hydrostatic reduction of intussusception and evaluation of the reduced mass with regard to perforation, ischemic signs or any other pathology. Intussusception is a leading cause of bowel obstruction in the pediatric population. Its diagnosis is usually based on clinical features and is confirmed either by Ultrasonography (U/S) or contrast enema, Computed Tomography (CT) scan is considered on rare occasions. Approximately 85% of these cases are reduced via pneumatic or hydrostatic enema. Radiological guided reduction of intussusception (air or saline enema) is considered the first line of treatment with an average success rate 80% (range 40%-90%). Surgical intervention is required for the cases with failed enema reduction, hemodynamic instability and/or peritonitis. This typically involves 10 to 20% of cases. Traditionally, unsuccessful radiological reduction has been followed by laparotomy. Later, the introduction of laparoscopy in pediatric surgical field has added another dimension to the management of intussusception. The use of laparoscopy has increased significantly in the past 20 years. It was initially utilized as a diagnostic modality after failed hydrostatic reduction of intussusception and then was used as a definitive treatment. Available reports claim advantages of laparoscopic over the open approach, such as less postoperative pain, reduced wound complications, minimal scarring, shorter hospital stay and an earlier return to normal activities. The purpose of this study was to evaluate the benefit of laparoscopy in guiding hydrostatic reduction of intussusception and evaluation of the reduced mass with regard to perforation, ischemic signs or any other pathology.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 08/08/2025 to make total sample size for the intervention to equal the sample size indicated here 242 53
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 08/08/2025 to make total sample size for the intervention to equal the sample size indicated here 242 53
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 05/08/2025 it is self-funded None, None, none, , Egypt, , Mohamed Shehata, El Geish st., Tanta, 31257, Egypt, Self Funded,