ANZCTR - Registration

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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]

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

Condition category

Condition code

Surgery

Surgical techniques

Oral and Gastrointestinal

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]

Not applicable

Comparator / control treatment

Two-layer closures were used as the comparator/control group.

Control group

Active

Outcomes

Primary outcome [1]

Operating time, assessed by examining data from medical records.

Timepoint [1]

operative period

Primary outcome [2]

Length of Stay, assessed by examining data from medical records.

Timepoint [2]

Postoperative period, assessed by examining data from medical records.

Primary outcome [3]

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]

Within 30 days of discharge

Secondary outcome [1]

Readmission, assessed by examining data from medical records.

Timepoint [1]

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?

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]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

Dunedin School of Medicine, University of Otago

Address [1]

201 Great King Street
Dunedin
9016

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

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

A/Prof Mark Thompson-Fawcett

Address

University of Otago
Department of Surgical Sciences
PO Box 56
Dunedin
9056

Country

New Zealand

Phone

+64 4740999 ex 8830

Fax

Mark.thompsonfawcett@otago.ac.nz

Contact person for public queries

Name

Mark Thompson-Fawcett

Address

University of Otago
Department of Surgical Sciences
PO Box 56
Dunedin
9056

Country

New Zealand

Phone

+64 4740999 ex 8830

Fax

Mark.thompsonfawcett@otago.ac.nz

Contact person for scientific queries

Name

Mark Thompson-Fawcett

Address

University of Otago
Department of Surgical Sciences
PO Box 56
Dunedin
9056

Country

New Zealand

Phone

+64 4740999 ex 8830

Fax

Mark.thompsonfawcett@otago.ac.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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