Colorectal SurgeryNCT06745505
EFFECTIVENESS of PRE-OPERATIVE BOWEL PREPARATION VS NO BOWEL PREPARATION on OUTCOMES of PEDIATRIC COLORECTAL SURGERIES
A study testing Bowel Preparation in people with Colorectal Surgery and Pediatric, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
To compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Colorectal Surgery, Pediatric, Bowel Preparation
- What is being tested?
- Bowel Preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2023to 19 Aug 2024
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with congenital condition such as Hirschsprung disease, anorectal malformation requiring pull through with or without covering colostomy.
- Patients with anorectal malformation requiring anorectoplasty with or without covering colostomy.
- Ileostomy/colostomy acquired due to intestinal perforation, intestinal obstruction, and trauma admitted for reversal.
- Age up to 12 years.
- Patients of both genders.
Who cannot join
- Any associated congenital morbid anomaly having Meningomyelocoele, Muscular dystrophy (were assessed on clinical examination)
- Patients with behavior disorders such as autism (were assessed during psychiatric history and clinical examination)
- Patients with behavioral disorder are difficult to counsel and follow up
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi
Rawalpindi, Punjab Province, 87500
About this study
To compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries.
Read the detailed description
Objective was to compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries. After approval from the ethical committee, 62 patients fulfilling the inclusion criteria were enrolled in this study from outpatient department. All participants were examined physically in person by the primary investigator. After which the patients were divided randomly into two groups A and B, 31 patients in each group. Group A patients were undergone bowel preparation while group B patients were not undergone bowel preparation. All patients were operated by a single consultant pediatric surgeon with more than 10 years of experience. Patients were called for follow up weekly till 6 weeks. Hospital stay was noted at the time of discharge. Wound infection rate was assessed till 30th post-operative day while anastomotic leak was ruled out on clinical and radiologic exam if symptoms were present. All the data of this study were analyzed in SPSS version 26. We concluded that that there is no significant difference in surgical outcomes between the group receiving the bowel preparation versus the group not receiving the bowel preparation in terms of surgical site infection rate, anastomotic leak and length of hospital stay.
- Conditions
- Colorectal Surgery, Pediatric, Bowel Preparation
- Being tested
- Bowel Preparation
- Keywords
- effectiveness, pre-operative bowel preparation, pediatric colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel PreparationProcedure or surgery
Group A received bowel preparation and Group B did not.
| Study group | Role | What they receive |
|---|---|---|
| Recieved Bowel Preparation | Experimental | Not described Receives: Procedure: Bowel Preparation |
| Did not receive Bowel Preparation | Active comparator | Not described Receives: Procedure: Bowel Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
No difference in surgical outcome after bowel preparation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jul 2023
- Primary completion30 Jun 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Holy Family Hospital, Pakistan
- Responsible party
- Principal investigator, Mansoor Ahmed, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Muhammad Salman Qamar, MBBS, Principal investigator, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745505
- Sponsor's protocol ID
- RMU-RRF-SUR002-23
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS of PRE-OPERATIVE BOWEL PREPARATION VS NO BOWEL PREPARATION on OUTCOMES of PEDIATRIC COLORECTAL SURGERIES
- ClinicalTrials.gov ID
- NCT06745505
- Acronym / sponsor ID
- RMU-RRF-SUR002-23
- Conditions
- Colorectal Surgery, Pediatric, Bowel Preparation
- Keywords
- effectiveness, pre-operative bowel preparation, pediatric colorectal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Collaborators
- Holy Family Hospital, Pakistan
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 20 Dec 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.
To compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries.
Detailed description
Objective was to compare the effectiveness of pre-operative bowel preparation vs no bowel preparation on outcomes of pediatric colorectal surgeries. After approval from the ethical committee, 62 patients fulfilling the inclusion criteria were enrolled in this study from outpatient department. All participants were examined physically in person by the primary investigator. After which the patients were divided randomly into two groups A and B, 31 patients in each group. Group A patients were undergone bowel preparation while group B patients were not undergone bowel preparation. All patients were operated by a single consultant pediatric surgeon with more than 10 years of experience. Patients were called for follow up weekly till 6 weeks. Hospital stay was noted at the time of discharge. Wound infection rate was assessed till 30th post-operative day while anastomotic leak was ruled out on clinical and radiologic exam if symptoms were present. All the data of this study were analyzed in SPSS version 26. We concluded that that there is no significant difference in surgical outcomes between the group receiving the bowel preparation versus the group not receiving the bowel preparation in terms of surgical site infection rate, anastomotic leak and length of hospital stay.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recieved Bowel Preparation | Experimental | Procedure: Bowel Preparation |
| Did not receive Bowel Preparation | Active comparator | Procedure: Bowel Preparation |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients with congenital condition such as Hirschsprung disease, anorectal malformation requiring pull through with or without covering colostomy.
- Patients with anorectal malformation requiring anorectoplasty with or without covering colostomy.
- Ileostomy/colostomy acquired due to intestinal perforation, intestinal obstruction, and trauma admitted for reversal.
- Age up to 12 years.
- Patients of both genders.
Key exclusion criteria (3 listed)
- Any associated congenital morbid anomaly having Meningomyelocoele, Muscular dystrophy (were assessed on clinical examination)
- Patients with behavior disorders such as autism (were assessed during psychiatric history and clinical examination)
- Patients with behavioral disorder are difficult to counsel and follow up
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 |
|---|---|---|
| Bowel PreparationGroup A received bowel preparation and Group B did not. | Procedure or surgery | Did not receive Bowel Preparation, Recieved Bowel Preparation |
Primary outcome
No difference in surgical outcome after bowel preparation
Time frame: 1 year
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 20 Dec 2024.
- 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.
Muhammad Salman Qamar, MBBS principal investigator
Rawalpindi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowel Preparation in people with Colorectal Surgery and Pediatric, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
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 5 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 20 Dec 2024. 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 Pakistan. 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?
No difference in surgical outcome after bowel preparation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2024.