Contact information
Type
Scientific
Primary contact
Prof Markus W Büchler
ORCID ID
Contact details
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)622 156 6200
markus.buechler@med.uni-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KSC 04/2003
Study information
Scientific title
Acronym
INSECT-Trial
Study hypothesis
Patients undergoing primary median laparotomy for an elective surgical intervention.
Ethics approval
The final protocol was approved by the ethics committee of the University of Heidelberg, Medical School.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
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
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/07/2004
Overall trial end date
31/08/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant 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
Recruitment start date
01/07/2004
Recruitment end date
31/08/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Funders
Funder type
Industry
Funder name
BBD Aesculap GmbH (Germany)
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
1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/15755324
2. Sub-study on the ethical review process in http://www.ncbi.nlm.nih.gov/pubmed/17264200
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19300233
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22316122
Publication citations
-
Protocol
Knaebel HP, Koch M, Sauerland S, Diener MK, Büchler MW, Seiler CM, , Interrupted or continuous slowly absorbable sutures - design of a multi-centre randomised trial to evaluate abdominal closure techniques INSECT-trial [ISRCTN24023541]., BMC Surg, 2005, 5, 3, doi: 10.1186/1471-2482-5-3.
-
Results
Seiler CM, Bruckner T, Diener MK, Papyan A, Golcher H, Seidlmayer C, Franck A, Kieser M, Büchler MW, Knaebel HP, Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541)., Ann. Surg., 2009, 249, 4, 576-582, doi: 10.1097/SLA.0b013e31819ec6c8.
-
Results
Fischer L, Knaebel HP, Golcher H, Bruckner T, Diener MK, Bachmann J, Büchler MW, Seiler CM, To whom do the results of the multicenter, randomized, controlled INSECT trial (ISRCTN 24023541) apply?--assessment of external validity., BMC Surg, 2012, 12, 2, doi: 10.1186/1471-2482-12-2.
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Seiler CM, Kellmeyer P, Kienle P, Büchler MW, Knaebel HP, , Assessment of the ethical review process for non-pharmacological multicentre studies in Germany on the basis of a randomised surgical trial., J Med Ethics, 2007, 33, 2, 113-118, doi: 10.1136/jme.2005.014605.