Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000353998
Ethics application status
Approved
Date submitted
29/03/2011
Date registered
5/04/2011
Date last updated
5/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validity of protective tube cecostomy
Scientific title
A prospective randomized clinical trial of tube cecostomy versus loop colostomy for fecal diversion after left hemicolectomy due to obstructing disease regarding mean operative time, hospital stay, mortality rate, stoma care and patient satisfaction,
Secondary ID [1] 259881 0
no
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
left hemicolectomy due to obstructing disease. 265473 0
Condition category
Condition code
Surgery 265627 265627 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A: 44 patients undergoing tube cecostomy for fecal diversion after left hemicolectomy due to obstructing cancer. Tube cecostomy was performed as described by Clark and Hubay in 1972.Two concentric purse-string sutures are placed over the anterior portion of the cecum leaving 3 cm. distance between them . A serosal incision is made central to the sutures and a suction trochar passed into the cecum to deflate it. Following this, the mucosa of the cecum is grasped with fine hemostats and elevated. A number 28 Foley catheter with a 30 cc. balloon is passed through the mucosal opening and a ligature is tied snugly around the everted mucosal edge to insure hemostasis. Then, 4 seromuscular stitches are applied to fix the cecum to the parietal peritoneum. The cecal tube is connected to the collecting tube. The cecal tubes were removed within 8 weeks.
Group B: 44 patients undergoing loop colostomy by exeriorization of the transverse colon in the form of loop as diverting stoma for fecal diversion after left hemicolectomy.
The colostomies were closed within 8 weeks.
Intervention code [1] 264304 0
Treatment: Surgery
Comparator / control treatment
Intervention: tube cecostomy Comparator/Control: loop colostomy .
The colostomies were closed within 8 weeks
Regarding the demographic data and the cause of bowel obstruction, we found no significant differences in both groups . Operative time, in group B, the duration of the primary operation was considerably longer and statistically significant compared with that of group A as long time was needed to mobilize the colon and fashioning the stoma. Stoma care and patient satisfaction were better in patients with cecostomy group.
The hospital stay for primary operation (admission, resuscitation, resection with colostomy) in patients of group B was 18-22 days and 7-9 days for colostomy closure . The total hospital stay in group B was 25-31 days . While the stay for primary operation in patients of group A ( admission , resuscitation, resection with cecostomy) was 14-16 days and 2-3 days for cecostomy tube removal . The total hospital stay in group A was 16-19 days [ P< 0.0003] .
Control group
Active

Outcomes
Primary outcome [1] 262412 0
Primary operation mortality rate.
Primary operation means the left hemicolectomy with the stoma construction.
operation mortality rate is assessed by clinical means
Timepoint [1] 262412 0
2 weeks postoperative
Secondary outcome [1] 273731 0
Operative time.
Operative time is assessed clinically
Timepoint [1] 273731 0
intraoperative
Secondary outcome [2] 273732 0
Stoma care and patient satisfaction, both are assessed by clinical data and patient's report.
Timepoint [2] 273732 0
3 months
Secondary outcome [3] 273733 0
Re-operations for stoma closure, is assessed clinically
Timepoint [3] 273733 0
after these 3 months
Secondary outcome [4] 273734 0
Hospital stay, is assessed according medical recrods data and registration unit
Timepoint [4] 273734 0
within one month

Eligibility
Key inclusion criteria
Inclusion criteria:
The following inclusion criteria were defined: (1) gross large bowel obstruction on plain films of the abdomen with compatible history and physical findings; (2) barium enema showing complete colorectal obstruction; (3) surgical finding of complete large bowel obstruction
Minimum age
22 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with perforation in addition to obstruction, and those with uncertain diagnosis or insufficient clinical data were also excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/1998
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment outside Australia
Country [1] 3320 0
Egypt
State/province [1] 3320 0

Funding & Sponsors
Funding source category [1] 264764 0
Hospital
Name [1] 264764 0
Port-Fouad general Hospital.
Country [1] 264764 0
Egypt
Primary sponsor type
Individual
Name
Aly Saber
Address
Port-Fouad general Hospital. Port-Fouad, Egypt
Country
Egypt
Secondary sponsor category [1] 263901 0
None
Name [1] 263901 0
Address [1] 263901 0
Country [1] 263901 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32408 0
Address 32408 0
Country 32408 0
Phone 32408 0
Fax 32408 0
Email 32408 0
Contact person for public queries
Name 15655 0
Aly Saber
Address 15655 0
Port-Fouad general Hospital, Port-Fouad, Egypt.
Country 15655 0
Egypt
Phone 15655 0
+2/066/ 3406474
Fax 15655 0
Email 15655 0
[email protected]
Contact person for scientific queries
Name 6583 0
Aly Saber
Address 6583 0
Port-Fouad general Hospital, Port-Fouad, Egypt.
Country 6583 0
Egypt
Phone 6583 0
+2/066/3406474
Fax 6583 0
Email 6583 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEfficacy of protective tube cecostomy after restorative resection for colorectal cancer: A randomized trial2013https://doi.org/10.1016/j.ijsu.2013.02.024
N.B. These documents automatically identified may not have been verified by the study sponsor.