Open Abdomen and Delayed Anastomosis After Anastomotic Dehiscences to Avoid Stomas (STOP-STOMA)

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.

Study Overview

• Status: Recruiting
• Conditions: Anastomotic Complication; Anastomotic Leak Small Intestine; Anastomotic Leak Large Intestine
• Intervention / Treatment: Procedure: Damage Control Surgery

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virginia Durán Muñoz-Cruzado, PhD; Phone Number: +34 620073024; Email: virginia.dm.87@gmail.com
• Study Contact Backup: Name: Servicio de Cirugía General y del Aparato Digestivo Hospital Universitario Virgen del Rocío

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocío, Sevilla
    • Contact: Virginia Durán Muñoz-Cruzado, PhD; Phone Number: +34620073024; Email: virginia.dm.87@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; 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.	Procedure: Damage Control Surgery; Delayed anastomosis
ACTIVE_COMPARATOR: Control group; 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.	Procedure: Damage Control Surgery; Delayed anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	To assess the mortality rate in each treatment group.	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	up to 57 months
Complications of open abdomen	To identify the complications associated with the use of open abdomen therapy.	up to 57 months
Early complications	To evaluate early complications in both groups.	up to 57 months
Late complications	To collect the late complications associated with each of the therapeutic options.	up to 57 months

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Principal Investigator: Virginia Durán Muñoz-Cruzado, PhD, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2024
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (ACTUAL): February 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: STOP STOMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No