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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Efficacy-Stoma after discharge
Study Overview
Brief 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.
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].
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 100 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with intestinal, ileocolic, colo-colic and colorectal anastomosis dehiscence.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Mortality(up to 57 months)
- Intensive Care Unit stay(up to 57 months)
- Complications of open abdomen(up to 57 months)
- Early complications(up to 57 months)
- Late complications(up to 57 months)