Condition category
Surgery
Date applied
06/11/2008
Date assigned
27/11/2008
Last edited
11/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sxrc.nhs.uk

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

Publication citations

Additional files

Editorial Notes

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