Contact information
Type
Scientific
Primary contact
Mr Muhammed Siddiqui
ORCID ID
Contact details
Worthing Hospital
Worthing
BN11 2DH
United Kingdom
+44 1903 205111
md0u812a@mac.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Bioabsorbable staple line reinforcement in circular stapling device is effective in reducing the incidence of anastomotic leak following rectosigmoid resection: a case control study
Acronym
STAPLE
Study hypothesis
The incidence of anastomotic leak after colorectal resection has been quoted from 7% to 14%. Anastomotic leak despite the development of modern techniques for colonic anastomosis is still one of the most devastating phenomenon in colorectal surgery. It is associated with significant increase in mortality-morbidity and a permanent stoma. Methods have been employed to reduce the anastomotic leak and include reinforcement suturing after the use of circular stapling device and the use of bioabsorbable staple line reinforcement.
Hypothesis:
There is no difference in the incidence of anastomotic leak in patients undergoing anterior resection using bioabsorbable reinforcement with a circular stapling device for colorectal or colocolic anastomosis compared with those without reinforcement.
Ethics approval
East Brighton Research Ethics Committee; pending as of 06/11/2008.
Study design
Interventional non-randomised controlled pilot trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anastomotic leak following rectosigmoid resection
Intervention
Bioabsorbable staple line reinforcement for circular stapler (GORE SEAMGUARD®). Disc will be incorporated between the two ends of circular stapling device before firing for anastomosis. First four procedures will be supervised and assisted by the medical representative from Gore. Procedures will be performed by Consultant Colorectal Surgeons and assisted by surgical registrars. All procedures will be video recorded. The controls (25 subjects) will be from the previous 12 months with no reinforcement.
Total duration of follow-up: one year.
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measures
Thirty-day anastomotic leak confirmed by clinical presentation, raised inflammatory markers, and/or ultrasonography of abdomen and pelvis and/or water soluble contrast enema and/or computerised tomography of abdomen and pelvis with or without contrast.
Secondary outcome measures
1. Associated co-morbidities which might influence the anastomotic healing. This will be assessed on a daily basis or as per clinical requirements whilst an in-patient and then three-monthly for one year.
2. Operative time
3. Blood loss
4. Post-operative complications. This will be assessed on a daily basis or as per clinical requirements whilst an in-patient and then three-monthly for one year.
5. Re-operation. Total duration of follow-up: one year.
6. Total hospital stay. Total duration of follow-up: one year.
7. Thirty-day mortality
Overall trial start date
01/12/2008
Overall trial end date
01/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with rectosigmoid pathology undergoing anterior resection or sigmoid colectomy with primary end to end colorectal anastomosis with or without defunctioning ileostomy
2. Patients of either sex
3. Patients of all age groups
4. Patients of any body mass index (BMI)
5. Patients undergoing elective surgery
6. Those patients will also be included who have had neoadjuvant radiotherapy or chemoradiotherpay for rectosigmoid tumours
7. Patients of American Society of Anaesthesiologists (ASA) I, ASA II and ASA III anaesthetic risks
6. Patients who agree and sign the consent to participate in this study
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Patients unable to give consent or refuse to participate in this study
2. Patients undergoing procedure on Confidential Enquiry into Patient Outcome and Death (CEPOD) list as an emergency
3. Patients undergoing procedure as a post-operative complication
4. Re-do procedure
Recruitment start date
01/12/2008
Recruitment end date
01/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Worthing Hospital
West Sussex
BN11 2DH
United Kingdom
Sponsor information
Organisation
Sussex NHS Research Consortium
Sponsor details
Worthing Hospital
Worthing
BN11 2DH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Sussex NHS Research Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
W. L. Gore & Associates, Inc. (USA) - donation of 5/25 samples
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary