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

Bioabsorbable staple line reinforcement in circular stapling device is effective in reducing the incidence of anastomotic leak following rectosigmoid resection: a case control study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38774835

Enrollment

Registered

2008-11-27

Start date

2008-12-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic leak following rectosigmoid resection Surgery Other complications of surgical and medical care, not elsewhere classified

Interventions

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 pro

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026