Open Abdomen and Delayed Anastomosis After Anastomotic Dehiscences to Avoid Stomas

NCT05233995 | Unknown

• 1 other identifier: STOP STOMA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anastomotic Complication; Anastomotic Leak Small Intestine; Anastomotic Leak Large Intestine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

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.

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.

Procedure: Damage Control Surgery

Interventions

Damage Control Surgery PROCEDURE

Delayed anastomosis

Control group; Intervention group

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with intestinal, ileocolic, colo-colic and colorectal anastomosis dehiscence.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío, Sevilla

Seville, 41013, Spain

RECRUITING

Study Officials

• Virginia Durán Muñoz-Cruzado, PhD

  Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginia Durán Muñoz-Cruzado, PhD

CONTACT

+34 620073024; virginia.dm.87@gmail.com

Servicio de Cirugía General y del Aparato Digestivo Hospital Universitario Virgen del Rocío

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: February 10, 2022
• Study Start: August 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

ES (1)