Condition category
Surgery
Date applied
03/02/2004
Date assigned
08/03/2004
Last edited
14/02/2012
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

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

Sponsor information

Organisation

BBD Aesculap GmbH (Germany)

Sponsor details

Am Aesculap Platz
Tuttlingen
78532
Germany

Sponsor type

Industry

Website

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes