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
Protocol serial number N/A
Sponsor Sussex NHS Research Consortium
Funders Sussex NHS Research Consortium (UK), W. L. Gore & Associates, Inc. (USA) - donation of 5/25 samples
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

+44 1903 205111
md0u812a@mac.com

Study information

Primary study designInterventional
Study designInterventional non-randomised controlled pilot trial
Secondary study designNon randomised controlled trial
Study type Participant information sheet
Scientific titleBioabsorbable staple line reinforcement in circular stapling device is effective in reducing the incidence of anastomotic leak following rectosigmoid resection: a case control study
Study acronymSTAPLE
Study objectivesThe 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) studiedAnastomotic leak following rectosigmoid resection
InterventionBioabsorbable 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 typeDevice
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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

Completion date01/12/2009

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Target sample size at registration50
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2008
Date of final enrolment01/12/2009

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Worthing Hospital
West Sussex
BN11 2DH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

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

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