Open Abdomen and Delayed Anastomosis After Anastomotic Dehiscences to Avoid Stomas

Anastomotic Complication Clinical Trial

— STOP-STOMA  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05233995
• Other study ID #: STOP STOMA
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2022
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Virginia Durán Muñoz-Cruzado, PhD
• Phone: +34 620073024
• Email: virginia.dm.87[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Complication
• Anastomotic Leak

Intervention

Procedure:
• Damage Control Surgery
Delayed anastomosis

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío, Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 57 months
Secondary	Mortality	To assess the mortality rate in each treatment group.	up to 57 months
Secondary	Intensive Care Unit stay	To measure the stay in the ICU of the patients in the experimental group and the control group	up to 57 months
Secondary	Complications of open abdomen	To identify the complications associated with the use of open abdomen therapy.	up to 57 months
Secondary	Early complications	To evaluate early complications in both groups.	up to 57 months
Secondary	Late complications	To collect the late complications associated with each of the therapeutic options.	up to 57 months