Bioabsorbable staple line reinforcement in circular stapling device to reduce the incidence of anastomotic leak following rectosigmoid resection

ISRCTN	ISRCTN38774835
DOI	https://doi.org/10.1186/ISRCTN38774835
Secondary identifying numbers	N/A

Submission date: 06/11/2008
Registration date: 27/11/2008
Last edited: 11/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Muhammed Siddiqui
Scientific

Worthing Hospital
Worthing
BN11 2DH
United Kingdom

Phone	+44 1903 205111
Email	md0u812a@mac.com

Study information

Study design	Interventional non-randomised controlled pilot trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	STAPLE
Study objectives	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(s)	East Brighton Research Ethics Committee; pending as of 06/11/2008.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/12/2008
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	50
Key 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
Key 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
Date of first enrolment	01/12/2008
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Worthing Hospital

West Sussex
BN11 2DH
United Kingdom

Sponsor information

Sussex NHS Research Consortium
Government

Worthing Hospital
Worthing
BN11 2DH
United Kingdom

Website	http://www.sxrc.nhs.uk

Funders

Funder type

Government

Sussex NHS Research Consortium (UK)

No information available

W. L. Gore & Associates, Inc. (USA) - donation of 5/25 samples

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/05/2016: No publications found, verifying study status with principal investigator.