Interrupted or continuous slowly absorbable Sutures - Evaluation of abdominal Closure Techniques
| ISRCTN | ISRCTN24023541 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24023541 |
| Secondary identifying numbers | KSC 04/2003 |
- Submission date
- 03/02/2004
- Registration date
- 08/03/2004
- Last edited
- 14/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Markus W Büchler
Scientific
Scientific
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
| Phone | +49 (0)622 156 6200 |
|---|---|
| markus.buechler@med.uni-heidelberg.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | 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 | |
| Study acronym | INSECT-Trial |
| Study objectives | Patients undergoing primary median laparotomy for an elective surgical intervention. |
| Ethics approval(s) | The final protocol was approved by the ethics committee of the University of Heidelberg, Medical School. |
| Health condition(s) or problem(s) studied | Abdominal surgery |
| Intervention | A standardised surgical approach for opening of the abdomen is performed in all patients with a midline incision of at least 15 cm length. The randomisation will proceed when the operation has been finished and the abdominal wall cavity should be closed. The treatment groups are: 1. Two continuous groups use the same technique with a 4 to 1 ratio (suture to incision length) 2. Two loops will be used in each patient and tied together in the middle of the incision 3. One interrupted suture group: vicryl sutures are used with standard pointed needles The stitches are performed from the cranial end to the middle of the incision and then from the caudal end also to the middle of the incision. Once all the stitches are made, each suture is tied with at least four knots. The subcutaneous tissue is not sutured and no subcutaneous drainage is used in all patients. The skin is closed with clips or single stitches of a non-absorbable monofilament suture material. The postoperative treatment is standardised. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The frequency of incisional hernias between three different abdominal fascia closure methods after one year postoperatively. |
| Secondary outcome measures | Frequencies of early and late onset complications such as burst abdomen, postoperative pulmonary complications, wound infections and incisional hernias after three years postoperatively. |
| Overall study start date | 01/07/2004 |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Aged equal or greater than 18 years 2. Expected survival time more than 12 months 3. Patients undergoing primary and elective median laparotomy (patients with prior laparoscopy or abdominal operation via paramedian incision (e.g. appendectomy) may be included in the trial) 4. Body mass index (BMI) less than 35 5. Expected length of incision greater than 15 cm 6. Patient must be able to give informed consent 7. Patient has given informed consent |
| Key exclusion criteria | 1. Peritonitis 2. Emergency surgery 3. Participation in another intervention-trial with interference of intervention and outcome of this study 4. Coagulopathy: a group of disorders of the blood clotting (coagulation) system in which bleeding is prolonged and excessive with abnormal values in the blood laboratory 5. Severe psychiatric or neurologic diseases 6. Lack of compliance 7. Drug- and/or alcohol-abuse according to local standards 8. Current immunosuppressive therapy (more than 40 mg of a corticoid per day or azathioprin) 9. Chemotherapy within 2 weeks before operation 10. Radiotherapy of the abdomen completed longer than 8 weeks before operation 11. Inability to follow the instructions given by the investigator or the telephone interviewer (insufficient command of language, dementia, lack of time) 12. Lack of informed consent |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
69120
Germany
Sponsor information
BBD Aesculap GmbH (Germany)
Industry
Industry
Am Aesculap Platz
Tuttlingen
78532
Germany
"ROR" |
https://ror.org/04nxj7050 |
|---|
Funders
Funder type
Industry
BBD Aesculap GmbH (Germany)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 08/03/2005 | Yes | No | |
| Other publications | Sub-study on the ethical review process | 01/02/2007 | Yes | No | |
| Results article | results | 01/04/2009 | Yes | No | |
| Results article | results | 08/02/2012 | Yes | No |
