Colorectal CancerBITEMENCT06220058
Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.
A study testing Closure of the midline laparotomy using the "small bites" technique and Closure of the midline laparotomy using the "small bites" technique with an absorbable PP mesh in people with Colorectal Cancer and Incisional Hernia, run by Fernandez Zamora at 1 site in Spain.
Trial summary
The 2023 World Journal of Emergency Surgery guidelines couldn't provide a recommendation for emergency abdominal wall closure due to insufficient consensus (>80% required). Available evidence, predominantly retrospective and heterogeneous, lacks differentiation between urgent and elective colorectal surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Incisional Hernia, Wound Infection
- What is being tested?
- Closure of the midline laparotomy using the "small bites" technique and Closure of the midline laparotomy using the "small bites" technique with an absorbable PP mesh
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2024to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy.
- Patients undergoing urgent laparoscopic surgery but necessitating conversion to midline laparotomy.
- Urgent surgical intervention required at the level of the colon and/or rectum, even in the presence of other abdominal pathologies.
- Age over 18 years.
- Signed informed consent (IC) from the patient and the investigator.
Who cannot join
- Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.
- BMI ≥ 35 kg/m2.
- Re-laparotomies.
- Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent.
- Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,
Girona, Catalonia, 17001
Frank Fernández, Dr., 972 94 02 60, cirurgia.girona.ics@gencat.cat
About this study
Official title: Comparison Between the Use of a Prophylactic Polypropylene Mesh and the "Small Bites" Technique in Midline Laparotomy Closure for Emergency Colorectal Surgery for Incisional Hernia Prevention
The 2023 World Journal of Emergency Surgery guidelines couldn't provide a recommendation for emergency abdominal wall closure due to insufficient consensus (>80% required). Available evidence, predominantly retrospective and heterogeneous, lacks differentiation between urgent and elective colorectal surgeries. Therefore, we advocate for a study comparing laparotomy closures in emergency colorectal surgery to contribute evidence on incisional hernia incidence and subsequent complications.
- Conditions
- Colorectal Cancer, Incisional Hernia, Wound Infection
- Being tested
- Closure of the midline laparotomy using the "small bites" technique, Closure of the midline laparotomy using the "small bites" technique with an absorbable PP mesh
- Keywords
- colorectal cancer, Hernia Incisional, Wound infection, small bites
- Medical subject headings
- Colorectal Neoplasms, Incisional Hernia, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of the midline laparotomy using the "small bites" techniqueProcedure or surgery
Closure of the midline laparotomy using the "small bites" technique will involve employing a monofilament polydioxanone suture with a gauge of 0 (PDS® II Ethicon, Bridgewater, NJ). No Redon drainage system will be left in the subcutaneous tissue.
Closure of the midline laparotomy using the "small bites" technique with an absorbable PP meshProcedure or surgery
Closure of the midline laparotomy using the "small bites" technique will involve employing a monofilament polydioxanone suture with a gauge of 0 (PDS® II Ethicon, Bridgewater, NJ). A partially absorbable low-density polypropylene suprapubic mesh (Ultrapro®, Ethicon) will be added. Mesh fixation will be done with absorbable staples (Ethicon SecurestrapTM) +/- slow-absorbing resorbable sutures at the discretion of the surgical team.
In the case of a diverting stoma, the prophylactic mesh will not encircle it. A Redon-type drainage will be left at the subcutaneous tissue level. One or two drains will be left at the discretion of the surgical team. Closure of the subcutaneous tissue will be performed with 2/0 or 3/0 absorbable, multifilament, interlocking sutures.
| Study group | Role | What they receive |
|---|---|---|
| Group Bites | Experimental | Closure of the midline laparotomy using the "small bites" technique Receives: Procedure: Closure of the midline laparotomy using the "small bites" technique |
| Group Mesh | Experimental | Closure of the midline laparotomy using the "small bites" technique adding a suprapubic polypropylene mesh. Receives: Procedure: Closure of the midline laparotomy using the "small bites" technique with an absorbable PP mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of incisional hernia.
Compare the incidence of midline laparotomy incisional hernia at one year post-surgery between the two groups: midline laparotomy closure using the "small bites" technique vs. midline laparotomy closure using the "small bites" technique supplemented with a suprapubic polypropylene mesh.
Measured: One year surgery
Secondary outcomes (2)
Incidence of wound infection
Compare the surgical wound infection rate at 30 days post-surgery, postoperative complications hindering subsequent treatment, as well as comorbidity related to surgical wound infection and rates of parastomal hernias.
Measured: 30 postoperative days
Morbidity and mortality rates
Compare morbidity and mortality between the two groups: initiation of tolerance to a solid oral diet and initiation of ambulation, anastomotic dehiscence, reinterventions, complications according to the Clavien-Dindo classification at 30 and 90 days, and mortality at 90 days.
Measured: 90 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start5 Feb 2024
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernandez Zamora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fernandez Zamora, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220058
- Sponsor's protocol ID
- 2023.227
- Acronym
- BITEME
- Status last verified
- Oct 2024
- First submitted
- 11 Jan 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Use of a Prophylactic Polypropylene Mesh and the "Small Bites" Technique in Midline Laparotomy Closure for Emergency Colorectal Surgery for Incisional Hernia Prevention
- ClinicalTrials.gov ID
- NCT06220058
- Acronym / sponsor ID
- BITEME / 2023.227
- Conditions
- Colorectal Cancer, Incisional Hernia, Wound Infection
- Keywords
- colorectal cancer, Hernia Incisional, Wound infection, small bites
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Fernandez ZamoraUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 2023 World Journal of Emergency Surgery guidelines couldn't provide a recommendation for emergency abdominal wall closure due to insufficient consensus (>80% required). Available evidence, predominantly retrospective and heterogeneous, lacks differentiation between urgent and elective colorectal surgeries. Therefore, we advocate for a study comparing laparotomy closures in emergency colorectal surgery to contribute evidence on incisional hernia incidence and subsequent complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Bites | Experimental | Procedure: Closure of the midline laparotomy using the "small bites" techniqueClosure of the midline laparotomy using the "small bites" technique |
| Group Mesh | Experimental | Procedure: Closure of the midline laparotomy using the "small bites" technique with an absorbable PP meshClosure of the midline laparotomy using the "small bites" technique adding a suprapubic polypropylene mesh. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy.
- Patients undergoing urgent laparoscopic surgery but necessitating conversion to midline laparotomy.
- Urgent surgical intervention required at the level of the colon and/or rectum, even in the presence of other abdominal pathologies.
- Age over 18 years.
- Signed informed consent (IC) from the patient and the investigator.
Key exclusion criteria (5 listed)
- Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.
- BMI ≥ 35 kg/m2.
- Re-laparotomies.
- Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent.
- Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closure of the midline laparotomy using the "small bites" techniqueClosure of the midline laparotomy using the "small bites" technique will involve employing a monofilament polydioxanone suture with a gauge of 0 (PDS® II Ethicon, Bridgewater, NJ). No Redon drainage system will be left in the subcutaneous tissue. | Procedure or surgery | Group Bites |
| Closure of the midline laparotomy using the "small bites" technique with an absorbable PP meshClosure of the midline laparotomy using the "small bites" technique will involve employing a monofilament polydioxanone suture with a gauge of 0 (PDS® II Ethicon, Bridgewater, NJ). A partially absorbable low-density polypropylene suprapubic mesh (Ultrapro®, Ethicon) will be added. Mesh fixation will be done with absorbable staples (Ethicon SecurestrapTM) +/- slow-absorbing resorbable sutures at the discretion of the surgical team. In the case of a diverting stoma, the prophylactic mesh will not encircle it. A Redon-type drainage will be left at the subcutaneous tissue level. One or two drains will be left at the discretion of the surgical team. Closure of the subcutaneous tissue will be performed with 2/0 or 3/0 absorbable, multifilament, interlocking sutures. | Procedure or surgery | Group Mesh |
Primary outcome
Incidence of incisional hernia.
Time frame: One year surgery
Compare the incidence of midline laparotomy incisional hernia at one year post-surgery between the two groups: midline laparotomy closure using the "small bites" technique vs. midline laparotomy closure using the "small bites" technique supplemented with a suprapubic polypropylene mesh.
2 secondary outcomes
Incidence of wound infection
Time frame: 30 postoperative days
Morbidity and mortality rates
Time frame: 90 postoperative days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of the midline laparotomy using the "small bites" technique and Closure of the midline laparotomy using the "small bites" technique with an absorbable PP mesh in people with Colorectal Cancer and Incisional Hernia, run by Fernandez Zamora at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank Fernández, Dr. (972 94 02 60, frankafernandez.girona.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of incisional hernia. (time frame: One year surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.