Efferent Loop Stimulation Previous to Ileostomy Closure. Ileostim Trial.

NCT05302557 | Unknown

• 1 other identifier: Ileostim 1.3
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The loop ileostomy is an effective method used to bypass faecal contents and reduce the sequelae of possible anastomotic leakage. I t is most often performed after a low anterior resection indicated for lower-middle rectal cancer. A second operation is required for closure, with a morbidity of about 25%. Many studies have been completed in order to detect possible risk factors - both patient-related and surgery-related - for complications in ileostomy closure surgery. Currently, there is a lack of research studies focused on the preoperative management of these patients. Our purpose is to reduce the complication rate by optimizing the preoperative status of the distal ileum and to analyze its impact on the reduction of postoperative ileus. Main objective: To assess whether efferent loop stimulation two weeks before ileostomy closure decreases the incidence of postoperative paralytic ileus.

Conditions

Ileostomy - Stoma; Ileus; Rectal Cancer; Surgical Complication

Outcome Measures

Primary Outcomes (1)

• Ileus

  Presence of paralytic ileus (defined as intolerance to oral food on or after the third postoperative day, in the absence of clinical or radiological signs of obstruction, requiring placement of a nasogastric tube or associated with two of the following: nausea/vomiting, abdominal distention and the absence of flatus).

  1 month

Secondary Outcomes (7)

• Hospital stay

  1 month

• Time to tolerate regular diet

  1 month

• Time to first passage of flatus

  1 month

• Time to first passage of stool

  1 month

• General morbidity

  6 months

Study Arms (2)

Interventional

EXPERIMENTAL

During the two weeks prior to the ileostomy closure procedure, daily stimulation of the efferent loop will be performed by irrigation with 500 ml of physiological saline or 500 ml of warm water, preferably bottled, associated with a nutritional thickener. The patient will be instructed by a stomatotherapy nurse. Stimulation will be performed up to the day before the intervention. Kegel exercises will be suggested. Every surgeon will use his or her usual technique for all patients included in the study, regardless of the group assigned in the randomization. All patients in both groups will receive the same antibiotic and antithrombotic prophylaxis. No antibiotic administration is expected during the postoperative period, following a Zero Surgical Infection (ZSI) protocol.

Other: Ileostomy stimulation

Control

NO INTERVENTION

Direct standard surgery. Every surgeon will use his or her usual technique for all patients included in the study, regardless of the group assigned in the randomization. All patients in both groups will receive the same antibiotic and antithrombotic prophylaxis. No antibiotic administration is expected during the postoperative period, following a Zero Surgical Infection (ZSI) protocol.

Interventions

Ileostomy stimulation OTHER

Daily stimulation of the efferent loop will be performed during the two weeks prior to the surgery.

Interventional

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years of age who undergo a scheduled protective ileostomy closure surgery, performed in rectal cancer surgery. All patients will follow a homogeneous protocol for testing the rectal anastomosis prior to closure, based on an opaque enema to rule out the presence of anastomotic leakage. Entry into the study does not affect the other surgical indications, in terms of time to ileostomy closure, type of operation or anaesthesia, or request for additional tests. Elective surgery. Patients who sign the informed consent document.

You may not qualify if:

• Patients undergoing simultaneous abdominal procedures at the time of ileostomy closure. History of protective ileostomy for a pathology other than rectal cancer. History of surgery in the ileal region.

Sponsors & Collaborators

• Universidad de León: lead

Study Sites (1)

Jorge Arredondo

León, Spain

RECRUITING

Related Publications (1)

• Blanco N, Oliva I, Tejedor P, Pastor E, Alvarellos A, Pastor C, Baixauli J, Arredondo J. ILEOSTIM trial: a study protocol to evaluate the effectiveness of efferent loop stimulation before ileostomy reversal. Tech Coloproctol. 2023 Dec;27(12):1251-1256. doi: 10.1007/s10151-023-02807-0. Epub 2023 Apr 27.

  PMID: 37106220 DERIVED

MeSH Terms

Conditions

Ileus; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases

Central Study Contacts

Jorge Arredondo

CONTACT

987987 23 74 00; jarredondo@outlook.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: December 9, 2021
• Primary Completion: December 9, 2023
• Study Completion: May 9, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)