Anastomosis, LeakingNCT07411885
Outcomes Of Single-Layer Extramucosal Colostomy Closure With Full-Thickness (All-Layers) Colostomy Closure
A study testing extramucasal colostomy closure and full thickness closure in people with Anastomosis, Leaking and Anastomotic Stenosis, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.
Trial summary
to compare the clinical outcomes of single-layer extramucosal colostomy closure with full-thickness (all-layers) colostomy closure in paediatric patients. Materials and Methods: This randomised controlled trial was conducted in the Department of Paediatric Surgery, Bahawal Victoria Hospital, Bahawalpur, from March… Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Anastomosis, Leaking, Anastomotic Stenosis
- What is being tested?
- extramucasal colostomy closure and full thickness closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 1 May 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Age ≤12 years
- Both genders
- Colostomy for:
- Anorectal malformations
- Intestinal obstruction
- Blunt abdominal trauma
Who cannot join
- • Neonates and infants
- Multiple congenital anomalies
- Complicated prior surgery
- Patients unfit for general anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Outcomes Of Single-Layer Extramucosal Colostomy Closure With Full-Thickness (All-Layers) Colostomy Closure In Paediatric Patients
to compare the clinical outcomes of single-layer extramucosal colostomy closure with full-thickness (all-layers) colostomy closure in paediatric patients.
Materials and Methods:
This randomised controlled trial was conducted in the Department of Paediatric Surgery, Bahawal Victoria Hospital, Bahawalpur, from March 2021 to March 2022. A total of 52 paediatric patients undergoing colostomy reversal for anorectal malformations, intestinal obstruction, or blunt abdominal trauma were enrolled. They were randomly allocated into two groups: Group A underwent full-thickness colostomy closure, whereas Group B underwent single-layer extramucosal closure. Patients were followed for 30 days postoperatively. Primary outcomes included anastomotic leak and anastomotic stricture. Secondary outcomes included operative time and duration of hospital stay. Statistical analysis was performed using SPSS 21, with p ≤0.05 considered significant.
Read the detailed description
INTRODUCTION Restoration of bowel continuity following colostomy requires meticulous intestinal anastomosis. The optimal technique continues to be debated, with the two commonly used methods being single-layer extramucosal anastomosis and full-thickness (all-layers) anastomosis. Historically, Halsted advocated extramucosal suturing and discouraged mucosal penetration, emphasising tissue preservation and improved healing. Contemporary literature supports single-layer techniques due to reduced tissue trauma, shorter operative time and lower cost, without compromising anastomotic integrity.
Colostomy reversal is frequently required in paediatric surgical practice, especially for anorectal malformations, Hirschsprung disease and intestinal perforations. Anastomotic leak remains the most critical postoperative complication, with rates reported between 1-7%. Leaks significantly increase morbidity, re-operation rates and hospital stay. Anastomotic stricture is another problematic long-term complication contributing to bowel obstruction.
Evidence suggests that single-layer extramucosal anastomosis may reduce luminal narrowing, preserve submucosal vascular plexus and provide comparable leak rates. However, data specific to paediatric colostomy closure remain limited.
This study was conducted to compare the effectiveness of single-layer extramucosal versus full-thickness colostomy closure in paediatric patients, focusing on operative time, anastomotic integrity and postoperative recovery.
________________________________________ MATERIALS \& METHODS Study design and setting A randomised controlled trial was conducted in the Department of Paediatric Surgery, Bahawal Victoria Hospital, Bahawalpur, from March 2021 to March 2022.
Sample size and sampling A total of 52 patients (26 per group) were included. Sample size was calculated at 90% power and 95% confidence level. Patients were allocated into two groups through sealed-envelope randomisation.
Inclusion criteria
- Age ≤12 years
- Both genders
- Colostomy for:
- Anorectal malformations
- Intestinal obstruction
- Blunt abdominal trauma Exclusion criteria
- Neonates and infants
- Multiple congenital anomalies
- Complicated prior surgery
- Patients unfit for general anaesthesia Preoperative assessment
All patients underwent:
- CBC
- LFTs
- Viral screening
- Serum electrolytes
- Distal loopogram Patients were kept NPO for 12 hours preoperatively and received rectal enemas. Prophylactic antibiotics were administered.
Operative technique Under general anaesthesia, the colostomy was mobilised. After confirming patency, bowel ends were prepared for anastomosis.
- Group A: Full-thickness (all-layers) anastomosis using inner full-thickness and outer seromuscular sutures.
- Group B: Single-layer interrupted extramucosal anastomosis using 3-0 Vicryl. Nasogastric decompression and standard postoperative monitoring were provided. Postoperative care and follow-up
- NG tube removed once bowel sounds returned
- Gradual reintroduction of oral feeds
- Patients discharged on oral antibiotics
- Follow-up at 7 days and 30 days Outcome measures
Primary outcomes:
- Anastomotic leak
- Anastomotic stricture
Secondary outcomes:
- Duration of operation
- Duration of hospital stay Statistical analysis SPSS 21.0 was used.
- Quantitative variables → mean ± SD, independent t-test
- Categorical variables → frequencies, percentages, Fisher exact test
- p ≤0.05 considered significant
- Conditions
- Anastomosis, Leaking, Anastomotic Stenosis
- Being tested
- extramucasal colostomy closure, full thickness closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extramucasal colostomy closureProcedure or surgery
stoma closed with extramucosal sutures
full thickness closureProcedure or surgery
stoma closed with full thickness sutures
| Study group | Role | What they receive |
|---|---|---|
| extramucosal closure | Experimental | colostomy closure done with extramucosal suturing Receives: Procedure: extramucasal colostomy closure |
| full thickness | Experimental | colostomy closure done with full thickness suturing Receives: Procedure: full thickness closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomosis leakage
leakage assessed by pneumoperitineum and abdominal signs
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Apr 2024
- Primary completion1 Apr 2025
- Study completion1 May 2025
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 Anastomosis, LeakingStudies 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
- Model description
- one with extramucosal closure and second group with full thickness closure
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children Hospital and Institute of Child Health, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Adeel Ashiq, Children Hospital and Institute of Child Health, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411885
- Sponsor's protocol ID
- adeel 9
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will decide once sure
Publications
Mirza B, et al. Stoma reversal outcomes. J Pediatr Surg Case Rep. 2020.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes Of Single-Layer Extramucosal Colostomy Closure With Full-Thickness (All-Layers) Colostomy Closure In Paediatric Patients
- ClinicalTrials.gov ID
- NCT07411885
- Acronym / sponsor ID
- adeel 9
- Conditions
- Anastomosis, Leaking, Anastomotic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Children Hospital and Institute of Child Health, LahoreUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 17 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.
to compare the clinical outcomes of single-layer extramucosal colostomy closure with full-thickness (all-layers) colostomy closure in paediatric patients.
Materials and Methods:
This randomised controlled trial was conducted in the Department of Paediatric Surgery, Bahawal Victoria Hospital, Bahawalpur, from March 2021 to March 2022. A total of 52 paediatric patients undergoing colostomy reversal for anorectal malformations, intestinal obstruction, or blunt abdominal trauma were enrolled. They were randomly allocated into two groups: Group A underwent full-thickness colostomy closure, whereas Group B underwent single-layer extramucosal closure. Patients were followed for 30 days postoperatively. Primary outcomes included anastomotic leak and anastomotic stricture. Secondary outcomes included operative time and duration of hospital stay. Statistical analysis was performed using SPSS 21, with p ≤0.05 considered significant.
Detailed description
INTRODUCTION Restoration of bowel continuity following colostomy requires meticulous intestinal anastomosis. The optimal technique continues to be debated, with the two commonly used methods being single-layer extramucosal anastomosis and full-thickness (all-layers) anastomosis. Historically, Halsted advocated extramucosal suturing and discouraged mucosal penetration, emphasising tissue preservation and improved healing. Contemporary literature supports single-layer techniques due to reduced tissue trauma, shorter operative time and lower cost, without compromising anastomotic integrity.
Colostomy reversal is frequently required in paediatric surgical practice, especially for anorectal malformations, Hirschsprung disease and intestinal perforations. Anastomotic leak remains the most critical postoperative complication, with rates reported between 1-7%. Leaks significantly increase morbidity, re-operation rates and hospital stay. Anastomotic stricture is another problematic long-term complication contributing to bowel obstruction.
Evidence suggests that single-layer extramucosal anastomosis may reduce luminal narrowing, preserve submucosal vascular plexus and provide comparable leak rates. However, data specific to paediatric colostomy closure remain limited.
This study was conducted to compare the effectiveness of single-layer extramucosal versus full-thickness colostomy closure in paediatric patients, focusing on operative time, anastomotic integrity and postoperative recovery.
________________________________________ MATERIALS \& METHODS Study design and setting A randomised controlled trial was conducted in the Department of Paediatric Surgery, Bahawal Victoria Hospital, Bahawalpur, from March 2021 to March 2022.
Sample size and sampling A total of 52 patients (26 per group) were included. Sample size was calculated at 90% power and 95% confidence level. Patients were allocated into two groups through sealed-envelope randomisation.
Inclusion criteria
- Age ≤12 years
- Both genders
- Colostomy for:
- Anorectal malformations
- Intestinal obstruction
- Blunt abdominal trauma Exclusion criteria
- Neonates and infants
- Multiple congenital anomalies
- Complicated prior surgery
- Patients unfit for general anaesthesia Preoperative assessment
All patients underwent:
- CBC
- LFTs
- Viral screening
- Serum electrolytes
- Distal loopogram Patients were kept NPO for 12 hours preoperatively and received rectal enemas. Prophylactic antibiotics were administered.
Operative technique Under general anaesthesia, the colostomy was mobilised. After confirming patency, bowel ends were prepared for anastomosis.
- Group A: Full-thickness (all-layers) anastomosis using inner full-thickness and outer seromuscular sutures.
- Group B: Single-layer interrupted extramucosal anastomosis using 3-0 Vicryl. Nasogastric decompression and standard postoperative monitoring were provided. Postoperative care and follow-up
- NG tube removed once bowel sounds returned
- Gradual reintroduction of oral feeds
- Patients discharged on oral antibiotics
- Follow-up at 7 days and 30 days Outcome measures
Primary outcomes:
- Anastomotic leak
- Anastomotic stricture
Secondary outcomes:
- Duration of operation
- Duration of hospital stay Statistical analysis SPSS 21.0 was used.
- Quantitative variables → mean ± SD, independent t-test
- Categorical variables → frequencies, percentages, Fisher exact test
- p ≤0.05 considered significant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- one with extramucosal closure and second group with full thickness closure
| Arm | Type | Receives |
|---|---|---|
| extramucosal closure | Experimental | Procedure: extramucasal colostomy closurecolostomy closure done with extramucosal suturing |
| full thickness | Experimental | Procedure: full thickness closurecolostomy closure done with full thickness suturing |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- • Age ≤12 years
Key exclusion criteria (4 listed)
- • Neonates and infants
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 |
|---|---|---|
| extramucasal colostomy closurestoma closed with extramucosal sutures | Procedure or surgery | extramucosal closure |
| full thickness closurestoma closed with full thickness sutures | Procedure or surgery | full thickness |
Primary outcome
anastomosis leakage
Time frame: 7 Days
leakage assessed by pneumoperitineum and abdominal signs
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 17 Feb 2026.
- BackgroundMirza B, et al. Stoma reversal outcomes. J Pediatr Surg Case Rep. 2020.
- Individual participant dataSharing planned: Undecided. will decide once sure
Related trials for Anastomosis, Leaking
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
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 extramucasal colostomy closure and full thickness closure in people with Anastomosis, Leaking and Anastomotic Stenosis, run by Children Hospital and Institute of Child Health, Lahore 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 6 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 17 Feb 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 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?
anastomosis leakage (time frame: 7 Days). 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 NCT07411885, 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 17 Feb 2026.