Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001596291
Ethics application status
Not required
Date submitted
19/09/2018
Date registered
26/09/2018
Date last updated
26/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are stapled and single-layer anastomoses similar and do they have advantages in reducing a patient's length of hospital stay when compared with two-layer anastomoses in the closure of loop ileostomy?
Scientific title
Are stapled and single-layer anastomoses similar and do they have advantages in reducing a patient's length of hospital stay when compared with two-layer anastomoses in the closure of loop ileostomy? A retrospective cohort study
Secondary ID [1] 295993 0
Nil Known
Universal Trial Number (UTN)
U1111-1219-9300
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
closure of temporary defunctioning loop ileostomy 309712 0
Condition category
Condition code
Surgery 308344 308344 0 0
Surgical techniques
Oral and Gastrointestinal 308533 308533 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This retrospective, single-centre cohort study includes all patients undergoing loop ileostomy closure between January 1999-April 2016. Demographic details, anastomotic technique, operative time, and patient outcomes were recorded for patients from admission to 30 days Post-discharge. Outcomes for patients with stapled ileostomy closures were compared with outcomes for patients with single and two-layer, hand-sewn closures.
Intervention code [1] 312467 0
Not applicable
Comparator / control treatment
Two-layer closures were used as the comparator/control group.
Control group
Active

Outcomes
Primary outcome [1] 307329 0
Operating time, assessed by examining data from medical records.
Timepoint [1] 307329 0
operative period
Primary outcome [2] 307330 0
Length of Stay, assessed by examining data from medical records.
Timepoint [2] 307330 0
Postoperative period, assessed by examining data from medical records.
Primary outcome [3] 307331 0
complications, assessed by examining data from medical records. Complications included:
ileus, anastomotic leak, missed enterotomy, pelvic sepsis, recurrent recto-vaginal fistula, wound infection, renal failure, central line sepsis, fascial dehiscence, bleeding, respiratory infections, urinary retention, sepsis from an uncertain source, Clostridium difficile, infection, re-operation.
Timepoint [3] 307331 0
Within 30 days of discharge
Secondary outcome [1] 351489 0
Readmission, assessed by examining data from medical records.
Timepoint [1] 351489 0
Within 30 days of discharge, assessed by examining data from medical records.

Eligibility
Key inclusion criteria
Patients undergoing a closure of defunctioning or diverting loop ileostomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded from analysis if:
There was incomplete documentation of the anastomotic technique, if the stoma closure was an ileo-colic anastomosis, if they had a reversal of the loop ileostomy in conjunction with another operation, or if the operation was performed acutely because of small bowel obstruction or a high output ileostomy.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Appropriate summary statistics were used to describe the sample, both overall and by procedure type. Medians alongside 25th and 75th percentiles are shown for skewed continuous variables. The patient characteristics age, sex, and ASA were compared between procedure types using a Kruskal-Wallis tests for continuous variables and Chi-squared tests for the categorical variables. For continuous outcomes (procedure duration), linear regression models were used to estimate differences in means between procedures, initially without adjustment, then adjusting for age, sex, and ASA; then adding consultant versus registrar. For binary outcomes (complications and readmission), Poisson regression models were used in a similar manner to estimate relative risks. However, the number of covariates included was limited when the number of events was small, so for count outcomes (days of stay), truncated Poisson or negative binomial (where the likelihood ratio test indicated over-dispersion) regression was used to model ratios of arithmetic means. All models included Froot’s clustered robust errors at the clinician level. For the linear regression models, residual normality and homoscedasticity were examined through appropriate plots and natural logarithmic transformations used where this improved the satisfaction of model assumptions. All analyses were performed using Stata 15.1 and two-sided (one-sided for Chi-squared tests) P<0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
1/09/2017
Date of last data collection
Anticipated
Actual
1/09/2017
Sample size
Target
300
Accrual to date
Final
244
Recruitment outside Australia
Country [1] 20825 0
New Zealand
State/province [1] 20825 0
Otago

Funding & Sponsors
Funding source category [1] 300588 0
University
Name [1] 300588 0
Dunedin School of Medicine, University of Otago
Country [1] 300588 0
New Zealand
Primary sponsor type
University
Name
Dunedin School of Medicine, University of Otago
Address
201 Great King Street
Dunedin
9016
Country
New Zealand
Secondary sponsor category [1] 300082 0
None
Name [1] 300082 0
Address [1] 300082 0
Country [1] 300082 0

Ethics approval
Ethics application status
Not required

Summary
Brief summary
Introduction
Loop ileostomy formation is a common practice for patients undergoing low anterior resection or restorative ileo-anal pouch surgery. This can be performed using either a stapled or hand-sewn technique, with or without a bowel resection. If hand-sewn, the closure can be one or two layers. Randomised controlled trials are yet to show a clear benefit of one closure technique over another, and meta-analyses are limited by the heterogeneity of published studies. Our primary aim is to compare stapled ileostomy closures with single- and two-layer, hand-sewn closures.

Materials and Methods
This retrospective, single-centre cohort study included all patients undergoing loop ileostomy closure between January 1999 – April 2016 at one hospital. Patient demographics, anastomotic technique, operative time, and patient outcomes were collected. Demographic data and American Society of Anaesthesiology (ASA) grade were compared, and linear regression models were used to assess differences in procedure means for operative time and length of stay. Differences in morbidity were analysed using Poisson regression models.

Results
The median age of patients was 67 years, and 43.4% of patients were female (n=244). There was no significant difference in mean operative time (71.5, 73.1, and 88.5 minutes, adjusted Wald P=0.262), or morbidity(21.5% vs 20.4% vs 17.6%, adjusted Wald P=0.934) between stapled, or hand-sewn anastomotic techniques, and no mortality in any group. Once adjusting for age, sex, ASA and consultant the length of stay (LOS) was similar between stapled and single-layer closures (4.2 vs 5.5 days, P=0.102), but was significantly different between stapled and two-layer closures (4.2 vs 8.3 days, adjusted Wald P=0.034, pairwise P=0.031).

Conclusion
Stapled and single-layered hand-sewn ileostomy closures are similar in length of the procedure, length of stay, and complication rates. Stapled ileostomy closures, however, are associated with a significant reduction in stay compared with two-layer, hand-sewn techniques.
Trial website
Trial related presentations / publications
Public notes
Under the policy of the Otago University Human Ethics Committee
ethical approval for audit activity is delegated to the head of the relevant department. Approval was given by the HOD of Surgical Sciences, 1/9/2016

Contacts
Principal investigator
Name 86798 0
A/Prof Mark Thompson-Fawcett
Address 86798 0
University of Otago
Department of Surgical Sciences
PO Box 56
Dunedin
9056
Country 86798 0
New Zealand
Phone 86798 0
+64 4740999 ex 8830
Fax 86798 0
Email 86798 0
[email protected]
Contact person for public queries
Name 86799 0
A/Prof Mark Thompson-Fawcett
Address 86799 0
University of Otago
Department of Surgical Sciences
PO Box 56
Dunedin
9056
Country 86799 0
New Zealand
Phone 86799 0
+64 4740999 ex 8830
Fax 86799 0
Email 86799 0
[email protected]
Contact person for scientific queries
Name 86800 0
A/Prof Mark Thompson-Fawcett
Address 86800 0
University of Otago
Department of Surgical Sciences
PO Box 56
Dunedin
9056
Country 86800 0
New Zealand
Phone 86800 0
+64 4740999 ex 8830
Fax 86800 0
Email 86800 0
[email protected]

No information has been provided regarding IPD availability


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Results publications and other study-related documents

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