Anastomotic ComplicationSTOP-STOMANCT05233995
Open Abdomen and Delayed Anastomosis After Anastomotic Dehiscences to Avoid Stomas
A study of Anastomotic Complication and Anastomotic Leak Small Intestine, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
Phase III clinical trial to evaluate the efficacy of the open abdomen as bridging therapy to perform transit reconstruction in patients with anastomotic dehiscence. It is a randomized controlled single-center study that will be carried out at the Virgen del Rocío University Hospital in Seville. Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Anastomotic Complication, Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with intestinal, ileocolic, colo-colic and colorectal anastomosis dehiscence.
Who cannot join
- Dehiscence of colorectal anastomosis in the middle or lower rectum.
- Dehiscence of esophagus-gastric or gastro-intestinal anastomosis.
- Dehiscence of a colorectal anastomosis in which it is impossible to close the rectal stump.
- Failure to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Servicio de Cirugía General y del Aparato Digestivo Hospital Universitario Virgen del Rocío contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen del Rocío, Sevilla
Seville, 41013
Virginia Durán Muñoz-Cruzado, PhD, +34620073024, virginia.dm.87@gmail.com
About this study
Official title: Clinical Trial Phase III to Evaluate the Effectiveness of the Open Abdomen as a Bridge Therapy to Perform Transit Reconstruction in Patients With Anastomosis Dehiscence.
Phase III clinical trial to evaluate the efficacy of the open abdomen as bridging therapy to perform transit reconstruction in patients with anastomotic dehiscence. It is a randomized controlled single-center study that will be carried out at the Virgen del Rocío University Hospital in Seville.
Read the detailed description
The selected patients will be those patients reoperated for an anastomotic dehiscence (intestinal, ileocolic, colo-colic or colorectal anastomosis) with localized or generalized peritonitis. Those patients with anastomosis in the middle or lower rectum will be excluded. Once selected, if all the inclusion criteria and none of the exclusion criteria are met, the patient (or family members in case the patient does not have a sufficient level of consciousness to understand and accept the information) will be informed in detail of the therapeutic options included in the study as well as their randomization and will sign the informed consent, understanding and accepting all the information.
The patients included in the experimental group will be operated on, performing the resection of the intestinal segment affected by the dehiscence, the sectioned intestinal ends will be left inside the abdomen without anastomosis, and open abdomen with Vacuum Assisted Closure therapy will be established. After surgery, the patient will be cared for in the intensive care unit where resuscitation will be carried out in order to improve the patient's general conditions. After 48 ± 24 hours, a second surgical procedure will be carried out where local conditions will be evaluated in order to decide performing a delayed anastomosis.
The patients included in the control group will be operated on with the resection of affected intestinal segment and a stoma with or without associated mucosal fistula will be performed at the same surgical time. After the procedure, the patient will be cared for in the intensive care unit in order to improve the general conditions of the patient.
The main efficacy variable will be the stoma generation during each of the interventions and the main safety variable will be mortality in both groups. Other secondary variables will be collected, such as: Intensive Care Unit (ICU) stay, need for a non planned re-intervention, early and late complications related to surgery, complications associated with the use of an open abdomen technique.
A descriptive analysis of the quantitative variables will be carried out using the size, means and standard or median deviations and percentiles, the bilateral 95% confidence interval and range (minimum and maximum) or P50 [P25 - P75].
The relationship between dichotomous qualitative variables will be studied using the chi-square test, or Fisher's exact statistic if necessary. The effect of each of the treatment groups on the outcome variables will be measured by calculating the relative risk (RR) together with its 95% confidence interval (CI).
In all patients, a follow-up visit will be carried out at one month, at 6 months and at 12 months after surgery in order to evaluate the associated complications and record possible adverse events.
The study will be reviewed and approved by the Seville Provincial Research and Ethics Committee.
- Conditions
- Anastomotic Complication, Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine
- Being tested
- Damage Control Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damage Control SurgeryProcedure or surgery
Delayed anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The patients included in the experimental group will be operated on, performing the resection of the intestinal segment affected by the dehiscence, the sectioned intestinal ends will be left without anastomosis, and open abdomen therapy will be established. After surgery, the patient will be cared for in the intensive care unit where intensive resuscitation will be carried out in order to improve the general conditions of the patient. After 48 ± 24 hours, a second surgical procedure will be performed where local conditions will be evaluated and the possibility of performing a delayed anastomosis will be evaluated. Receives: Procedure: Damage Control Surgery |
| Control group | Active comparator | The patients included in the control group will be operated on with a resection of the affected intestinal segment and a stoma with or without associated mucosal fistula will be performed at the same surgical time. After the procedure, the patient will be cared for in the intensive care unit in order to improve the general conditions of the patient. Receives: Procedure: Damage Control Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy-Stoma after discharge
To assess the efficacy of the open abdomen surgical strategy with delayed anastomosis in patients requiring reoperation for anastomotic dehiscence. Number of stoma after discharge
Measured: up to 57 months
Secondary outcomes (5)
Mortality
To assess the mortality rate in each treatment group.
Measured: up to 57 months
Intensive Care Unit stay
To measure the stay in the ICU of the patients in the experimental group and the control group
Measured: up to 57 months
Complications of open abdomen
To identify the complications associated with the use of open abdomen therapy.
Measured: up to 57 months
Early complications
To evaluate early complications in both groups.
Measured: up to 57 months
Late complications
To collect the late complications associated with each of the therapeutic options.
Measured: up to 57 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic ComplicationStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginia Durán Muñoz-Cruzado, PhD, Principal investigator, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233995
- Sponsor's protocol ID
- STOP STOMA
- Acronym
- STOP-STOMA
- Status last verified
- Jun 2022
- First submitted
- 19 Nov 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Phase III to Evaluate the Effectiveness of the Open Abdomen as a Bridge Therapy to Perform Transit Reconstruction in Patients With Anastomosis Dehiscence.
- ClinicalTrials.gov ID
- NCT05233995
- Acronym / sponsor ID
- STOP-STOMA / STOP STOMA
- Conditions
- Anastomotic Complication, Anastomotic Leak Small Intestine, Anastomotic Leak Large Intestine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 10 Feb 2022 (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.
Phase III clinical trial to evaluate the efficacy of the open abdomen as bridging therapy to perform transit reconstruction in patients with anastomotic dehiscence. It is a randomized controlled single-center study that will be carried out at the Virgen del Rocío University Hospital in Seville.
Detailed description
The selected patients will be those patients reoperated for an anastomotic dehiscence (intestinal, ileocolic, colo-colic or colorectal anastomosis) with localized or generalized peritonitis. Those patients with anastomosis in the middle or lower rectum will be excluded. Once selected, if all the inclusion criteria and none of the exclusion criteria are met, the patient (or family members in case the patient does not have a sufficient level of consciousness to understand and accept the information) will be informed in detail of the therapeutic options included in the study as well as their randomization and will sign the informed consent, understanding and accepting all the information.
The patients included in the experimental group will be operated on, performing the resection of the intestinal segment affected by the dehiscence, the sectioned intestinal ends will be left inside the abdomen without anastomosis, and open abdomen with Vacuum Assisted Closure therapy will be established. After surgery, the patient will be cared for in the intensive care unit where resuscitation will be carried out in order to improve the patient's general conditions. After 48 ± 24 hours, a second surgical procedure will be carried out where local conditions will be evaluated in order to decide performing a delayed anastomosis.
The patients included in the control group will be operated on with the resection of affected intestinal segment and a stoma with or without associated mucosal fistula will be performed at the same surgical time. After the procedure, the patient will be cared for in the intensive care unit in order to improve the general conditions of the patient.
The main efficacy variable will be the stoma generation during each of the interventions and the main safety variable will be mortality in both groups. Other secondary variables will be collected, such as: Intensive Care Unit (ICU) stay, need for a non planned re-intervention, early and late complications related to surgery, complications associated with the use of an open abdomen technique.
A descriptive analysis of the quantitative variables will be carried out using the size, means and standard or median deviations and percentiles, the bilateral 95% confidence interval and range (minimum and maximum) or P50 [P25 - P75].
The relationship between dichotomous qualitative variables will be studied using the chi-square test, or Fisher's exact statistic if necessary. The effect of each of the treatment groups on the outcome variables will be measured by calculating the relative risk (RR) together with its 95% confidence interval (CI).
In all patients, a follow-up visit will be carried out at one month, at 6 months and at 12 months after surgery in order to evaluate the associated complications and record possible adverse events.
The study will be reviewed and approved by the Seville Provincial Research and Ethics Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Damage Control SurgeryThe patients included in the experimental group will be operated on, performing the resection of the intestinal segment affected by the dehiscence, the sectioned intestinal ends will be left without anastomosis, and open abdomen therapy will be established. After surgery, the patient will be cared for in the intensive care unit where intensive resuscitation will be carried out in order to improve the general conditions of the patient. After 48 ± 24 hours, a second surgical procedure will be performed where local conditions will be evaluated and the possibility of performing a delayed anastomosis will be evaluated. |
| Control group | Active comparator | Procedure: Damage Control SurgeryThe patients included in the control group will be operated on with a resection of the affected intestinal segment and a stoma with or without associated mucosal fistula will be performed at the same surgical time. After the procedure, the patient will be cared for in the intensive care unit in order to improve the general conditions of the patient. |
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with intestinal, ileocolic, colo-colic and colorectal anastomosis dehiscence.
Key exclusion criteria (4 listed)
- Dehiscence of colorectal anastomosis in the middle or lower rectum.
- Dehiscence of esophagus-gastric or gastro-intestinal anastomosis.
- Dehiscence of a colorectal anastomosis in which it is impossible to close the rectal stump.
- Failure to sign the informed consent.
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 |
|---|---|---|
| Damage Control SurgeryDelayed anastomosis | Procedure or surgery | Control group, Intervention group |
Primary outcome
Efficacy-Stoma after discharge
Time frame: up to 57 months
To assess the efficacy of the open abdomen surgical strategy with delayed anastomosis in patients requiring reoperation for anastomotic dehiscence. Number of stoma after discharge
5 secondary outcomes
Mortality
Time frame: up to 57 months
Intensive Care Unit stay
Time frame: up to 57 months
Complications of open abdomen
Time frame: up to 57 months
Early complications
Time frame: up to 57 months
Late complications
Time frame: up to 57 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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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. This study is not recruiting at the moment.
Servicio de Cirugía General y del Aparato Digestivo Hospital Universitario Virgen del Rocío contact
Virginia Durán Muñoz-Cruzado, PhD principal investigator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Anastomotic Complication and Anastomotic Leak Small Intestine, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginia Durán Muñoz-Cruzado, PhD (+34 620073024, virginia.dm.87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy-Stoma after discharge (time frame: up to 57 months). 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 15 Jun 2022.