Clinical trial NCT05233995: Open Abdomen and Delayed Anastomosis After Anastomotic Dehiscences to Avoid Stomas
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anastomotic Complication
Anastomotic Leak Small Intestine
Anastomotic Leak Large Intestine
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[P25 - P75\].

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy-Stoma after discharge
timeFrame: up to 57 months
Secondary outcomes:
measure: Mortality
timeFrame: up to 57 months
measure: Intensive Care Unit stay
timeFrame: up to 57 months
measure: Complications of open abdomen
timeFrame: up to 57 months
measure: Early complications
timeFrame: up to 57 months
measure: Late complications
timeFrame: up to 57 months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío, Sevilla
Study officials:
affiliation: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
name: Virginia Durán Muñoz-Cruzado, PhD
role: PRINCIPAL_INVESTIGATOR
References: