Postoperative IleusNCT06974500
Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
An observational study of Postoperative Ileus and Colorectal Cancer Control and Prevention, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Stoma creation is a common surgical procedure, employed in certain contexts within general surgery, particularly in colorectal and emergency surgery. Although stoma formation is a life-saving technique, the diversion of intestinal contents has pathophysiological, aesthetic, and psychological repercussions on patients'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus, Colorectal Cancer Control and Prevention, Stoma - Ileostomy
- What is being tested?
- Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agent
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 1 Apr 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age who, regardless of the underlying cause, have an ileostomy and a medical indication for intestinal transit reconstruction.
Who may be able to join
None listed.
Who cannot join
- Subjects with an ileostomy who do not wish to undergo intestinal reconstruction.
- Subjects who are unable to complete at least two weeks of efferent loop stimulation prior to reconstruction surgery.
- Subjects who do not provide consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid
Luis Dr.Asensio Gómez, Consultant, +34 650675894, lasensio@salud.madrid.org
About this study
Stoma creation is a common surgical procedure, employed in certain contexts within general surgery, particularly in colorectal and emergency surgery. Although stoma formation is a life-saving technique, the diversion of intestinal contents has pathophysiological, aesthetic, and psychological repercussions on patients' lives. Stomas may be either permanent or temporary. In temporary cases, a second intervention is required to perform ileostomy closure and restore normal intestinal transit.
Several studies indicate that stimulation of the efferent loop prior to ileostomy closure yields benefits in patients' postoperative outcomes. Currently, there is no established protocol for this intervention at Hospital Universitario La Paz. However, implementing such a protocol-given that it is a simple, inexpensive, and accessible intervention-could offer significant cost-effectiveness. It may reduce complications and hospital stay, improve patients' quality of life, and represent a valuable contribution to the General Surgery Departmen
Read the detailed description
Implementation of a Protocol for Efferent Limb Stimulation Prior to Ileostomy Closure at Hospital Universitario La Paz
The formation of stomas is a common surgical procedure, used in specific scenarios within general surgery, particularly in colorectal and emergency settings. While the creation of a stoma is often life-saving, the diversion of intestinal contents carries significant pathophysiological, aesthetic, and psychological repercussions for patients. Stomas may be permanent or temporary. In cases of temporary stomas, a second surgical procedure is required to close the ileostomy and re-establish normal intestinal continuity.
Several studies, as reviewed in this work, suggest that stimulation of the efferent limb prior to ileostomy closure provides measurable benefits in terms of patients' postoperative recovery. At present, however, there is no established protocol for this intervention at Hospital Universitario La Paz. This is despite its simplicity, low cost, and minimal risk, and its potential to improve patient outcomes, reduce postoperative complications, and shorten hospital stays. Implementing such a protocol could not only enhance patient care but also represent a meaningful quality improvement for the Department of General and Digestive Surgery.
The rationale behind this study is to demonstrate the clinical advantages of efferent limb stimulation before ileostomy closure and to establish a formal protocol for its use. This protocol would apply to patients with an ileostomy, regardless of the underlying condition, who are scheduled for intestinal reconstruction at Hospital Universitario La Paz. Complications following ileostomy closure are known to be common, often leading to prolonged hospitalisation. These complications result in increased direct costs from longer admissions, as well as additional use of healthcare resources through potential reoperations or pharmacological treatments.
Given these challenges, our objective is to reduce the duration of hospital stay and the incidence of complications by introducing a preoperative intervention that is both accessible and clinically effective. Efferent limb stimulation, conducted prior to closure, may provide an opportunity to mitigate common postoperative problems and improve overall patient recovery.
Our hypothesis is that stimulation of the efferent limb in patients with an ileostomy-using saline solution and thickening agents-administered between two and four weeks before intestinal reconstruction surgery, promotes faster recovery of bowel function, reduces length of hospital stay, and decreases postoperative complications. The primary outcome of interest is the reduction in the number of inpatient days, specifically measured from surgery to discharge.
Secondary objectives include evaluating the impact of the intervention on the incidence of postoperative paralytic ileus, diarrhoea, surgical site infections, and inflammatory response as indicated by C-reactive protein (CRP) levels. Additionally, the study will assess the feasibility and adherence to the newly implemented protocol.
The study is designed as a prospective cohort study with historical controls. The study population will consist of patients over the age of 18 with an ileostomy, regardless of the underlying pathology, who are scheduled for surgical restoration of intestinal continuity. Two groups will be analysed. The case group will include prospective patients who receive daily efferent limb stimulation with saline solution and a thickening agent for at least two weeks prior to surgery. The control group will consist of retrospective data from patients who underwent ileostomy closure prior to the implementation of this protocol and did not receive any form of preoperative stimulation.
Once enrolled, patients in the intervention group will follow the usual standards of care with the addition of the efferent limb stimulation protocol. All procedures and follow-up visits will be designed to ensure patient safety and will not introduce additional clinical risk
- Being tested
- Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agent
- Keywords
- Ileostomy , Stoma, Colorectal, Posoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agentProcedure or surgery
Participants in the intervention group will undergo daily stimulation of the efferent limb for a minimum of two weeks prior to ileostomy closure. The procedure involves the instillation of a solution composed of saline and a thickening agent through the efferent limb of the ileostomy via the inactive orifice. This is performed by the patient at home following specific training and instructions provided during a preoperative consultation.
The stimulation begins the day after the pre-anaesthesia consultation and is carried out once per day. Patients are supported with a structured follow-up, including one physical consultation in the stoma clinic, telephone contact with the research team every 48 hours, and access to an email address for queries. The objective of the intervention is to recondition the excluded colon before the restoration of intestinal continuity in order to reduce postoperative complications.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Retrospective data from patients who did not undergo pre-ileostomy closure stimulation prior to the introduction of the efferent loop stimulation protocol. | |
| Arm Cases | Prospective patients with daily stimulation of the efferent loop at least two weeks prior to surgery with saline and thickener. Receives: Procedure: Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
LOS
Difference in mean number of days of hospital stay between control and case group
Measured: 30 days after reconstructive surgery
Secondary outcomes (6)
Paralytic Ileus
Percentage of patients diagnosed with paralytic ileus during admission in the case group compared to the control group
Measured: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
Diarrhoea
Percentage of patients diagnosed with diarrhoea during admission in the case group compared to the control group
Measured: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
ISS
Percentage of patients diagnosed with surgical wound infection 30 days after surgery in the case group compared to the control group
Measured: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
Protocol
Percentage of the number of patients included in the protocol compared to the total number of ileostomies reconstructed since the protocol was implemented
Measured: through study completion, an average 2 years
CRP
Percentage of the mean blood CRP value on the second and fourth day of patients undergoing EAE compared to the mean blood CRP value on the second and fourth day of patients without EAE.
Measured: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
PCT
Percentage of the mean blood PCT value on the second and fourth posoperative day
Measured: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Asensio Gomez, Hospital Universitario La Paz
- Investigators
- Luis Asensio, Consultant, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974500
- Sponsor's protocol ID
- PI-6255
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD due to privacy concerns and restrictions related to the informed consent provided by participants
Publications
Fernandez Lopez F, Gonzalez Lopez J, Paz Novo M, Ladra Gonzalez MJ, Paredes Cotore J. Stimulation the efferent limb before loop ileostomy closure with short chain fatty acids. Cir Esp (Engl Ed). 2019 Jan;97(1):59-61. doi: 10.1016/j.ciresp.2018.06.018. Epub 2018 Oct 15. No abstract available. English, Spanish.
PubMed 30337046Lloyd AJ, Hardy NP, Jordan P, Ryan EJ, Whelan M, Clancy C, O'Riordan J, Kavanagh DO, Neary P, Sahebally SM. Efferent limb stimulation prior to loop ileostomy closure: a systematic review and meta-analysis. Tech Coloproctol. 2023 Dec 14;28(1):15. doi: 10.1007/s10151-023-02875-2.
PubMed 38095756Ocana J, Garcia-Perez JC, Labalde-Martinez M, Rodriguez-Velasco G, Moreno I, Vivas A, Clemente-Esteban I, Ballestero A, Abadia P, Ferrero E, Fernandez-Cebrian JM, Die J. Can physiological stimulation prior to ileostomy closure reduce postoperative ileus? A prospective multicenter pilot study. Tech Coloproctol. 2022 Aug;26(8):645-653. doi: 10.1007/s10151-022-02620-1. Epub 2022 May 21.
PubMed 35596903Garfinkle R, Demian M, Sabboobeh S, Moon J, Hulme-Moir M, Liberman AS, Feinberg S, Hayden DM, Chadi SA, Demyttenaere S, Samuel L, Hotakorzian N, Quintin L, Morin N, Faria J, Ghitulescu G, Vasilevsky CA, Boutros M; Bowel Stimulation Research Collaborative. Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial. Surg Endosc. 2023 May;37(5):3934-3943. doi: 10.1007/s00464-022-09510-5. Epub 2022 Aug 19.
PubMed 35984521
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Efferent Loop Stimulation Protocol Prior to Ileostomy Closure at La Paz University Hospital
- ClinicalTrials.gov ID
- NCT06974500
- Acronym / sponsor ID
- PI-6255
- Keywords
- Ileostomy , Stoma, Colorectal, Posoperative
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stoma creation is a common surgical procedure, employed in certain contexts within general surgery, particularly in colorectal and emergency surgery. Although stoma formation is a life-saving technique, the diversion of intestinal contents has pathophysiological, aesthetic, and psychological repercussions on patients' lives. Stomas may be either permanent or temporary. In temporary cases, a second intervention is required to perform ileostomy closure and restore normal intestinal transit.
Several studies indicate that stimulation of the efferent loop prior to ileostomy closure yields benefits in patients' postoperative outcomes. Currently, there is no established protocol for this intervention at Hospital Universitario La Paz. However, implementing such a protocol-given that it is a simple, inexpensive, and accessible intervention-could offer significant cost-effectiveness. It may reduce complications and hospital stay, improve patients' quality of life, and represent a valuable contribution to the General Surgery Departmen
Detailed description
Implementation of a Protocol for Efferent Limb Stimulation Prior to Ileostomy Closure at Hospital Universitario La Paz
The formation of stomas is a common surgical procedure, used in specific scenarios within general surgery, particularly in colorectal and emergency settings. While the creation of a stoma is often life-saving, the diversion of intestinal contents carries significant pathophysiological, aesthetic, and psychological repercussions for patients. Stomas may be permanent or temporary. In cases of temporary stomas, a second surgical procedure is required to close the ileostomy and re-establish normal intestinal continuity.
Several studies, as reviewed in this work, suggest that stimulation of the efferent limb prior to ileostomy closure provides measurable benefits in terms of patients' postoperative recovery. At present, however, there is no established protocol for this intervention at Hospital Universitario La Paz. This is despite its simplicity, low cost, and minimal risk, and its potential to improve patient outcomes, reduce postoperative complications, and shorten hospital stays. Implementing such a protocol could not only enhance patient care but also represent a meaningful quality improvement for the Department of General and Digestive Surgery.
The rationale behind this study is to demonstrate the clinical advantages of efferent limb stimulation before ileostomy closure and to establish a formal protocol for its use. This protocol would apply to patients with an ileostomy, regardless of the underlying condition, who are scheduled for intestinal reconstruction at Hospital Universitario La Paz. Complications following ileostomy closure are known to be common, often leading to prolonged hospitalisation. These complications result in increased direct costs from longer admissions, as well as additional use of healthcare resources through potential reoperations or pharmacological treatments.
Given these challenges, our objective is to reduce the duration of hospital stay and the incidence of complications by introducing a preoperative intervention that is both accessible and clinically effective. Efferent limb stimulation, conducted prior to closure, may provide an opportunity to mitigate common postoperative problems and improve overall patient recovery.
Our hypothesis is that stimulation of the efferent limb in patients with an ileostomy-using saline solution and thickening agents-administered between two and four weeks before intestinal reconstruction surgery, promotes faster recovery of bowel function, reduces length of hospital stay, and decreases postoperative complications. The primary outcome of interest is the reduction in the number of inpatient days, specifically measured from surgery to discharge.
Secondary objectives include evaluating the impact of the intervention on the incidence of postoperative paralytic ileus, diarrhoea, surgical site infections, and inflammatory response as indicated by C-reactive protein (CRP) levels. Additionally, the study will assess the feasibility and adherence to the newly implemented protocol.
The study is designed as a prospective cohort study with historical controls. The study population will consist of patients over the age of 18 with an ileostomy, regardless of the underlying pathology, who are scheduled for surgical restoration of intestinal continuity. Two groups will be analysed. The case group will include prospective patients who receive daily efferent limb stimulation with saline solution and a thickening agent for at least two weeks prior to surgery. The control group will consist of retrospective data from patients who underwent ileostomy closure prior to the implementation of this protocol and did not receive any form of preoperative stimulation.
Once enrolled, patients in the intervention group will follow the usual standards of care with the addition of the efferent limb stimulation protocol. All procedures and follow-up visits will be designed to ensure patient safety and will not introduce additional clinical risk
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | – | –Retrospective data from patients who did not undergo pre-ileostomy closure stimulation prior to the introduction of the efferent loop stimulation protocol. |
| Arm Cases | – | Procedure: Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agentProspective patients with daily stimulation of the efferent loop at least two weeks prior to surgery with saline and thickener. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age who, regardless of the underlying cause, have an ileostomy and a medical indication for intestinal transit reconstruction.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Subjects with an ileostomy who do not wish to undergo intestinal reconstruction.
- Subjects who are unable to complete at least two weeks of efferent loop stimulation prior to reconstruction surgery.
- Subjects who do not provide consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily efferent limb stimulation for at least two weeks prior to surgery using saline solution and a thickering agentParticipants in the intervention group will undergo daily stimulation of the efferent limb for a minimum of two weeks prior to ileostomy closure. The procedure involves the instillation of a solution composed of saline and a thickening agent through the efferent limb of the ileostomy via the inactive orifice. This is performed by the patient at home following specific training and instructions provided during a preoperative consultation. The stimulation begins the day after the pre-anaesthesia consultation and is carried out once per day. Patients are supported with a structured follow-up, including one physical consultation in the stoma clinic, telephone contact with the research team every 48 hours, and access to an email address for queries. The objective of the intervention is to recondition the excluded colon before the restoration of intestinal continuity in order to reduce postoperative complications. | Procedure or surgery | Arm Cases |
Primary outcome
LOS
Time frame: 30 days after reconstructive surgery
Difference in mean number of days of hospital stay between control and case group
6 secondary outcomes
Paralytic Ileus
Time frame: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
Diarrhoea
Time frame: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
ISS
Time frame: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
Protocol
Time frame: through study completion, an average 2 years
CRP
Time frame: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
PCT
Time frame: Postoperative hospital stay (up to 15 days after surgery or until discharge, whichever occurs first)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 30337046Fernandez Lopez F, Gonzalez Lopez J, Paz Novo M, Ladra Gonzalez MJ, Paredes Cotore J. Stimulation the efferent limb before loop ileostomy closure with short chain fatty acids. Cir Esp (Engl Ed). 2019 Jan;97(1):59-61. doi: 10.1016/j.ciresp.2018.06.018. Epub 2018 Oct 15. No abstract available. English, Spanish.
- Background: PubMed 38095756Lloyd AJ, Hardy NP, Jordan P, Ryan EJ, Whelan M, Clancy C, O'Riordan J, Kavanagh DO, Neary P, Sahebally SM. Efferent limb stimulation prior to loop ileostomy closure: a systematic review and meta-analysis. Tech Coloproctol. 2023 Dec 14;28(1):15. doi: 10.1007/s10151-023-02875-2.
- Background: PubMed 35596903Ocana J, Garcia-Perez JC, Labalde-Martinez M, Rodriguez-Velasco G, Moreno I, Vivas A, Clemente-Esteban I, Ballestero A, Abadia P, Ferrero E, Fernandez-Cebrian JM, Die J. Can physiological stimulation prior to ileostomy closure reduce postoperative ileus? A prospective multicenter pilot study. Tech Coloproctol. 2022 Aug;26(8):645-653. doi: 10.1007/s10151-022-02620-1. Epub 2022 May 21.
- Background: PubMed 35984521Garfinkle R, Demian M, Sabboobeh S, Moon J, Hulme-Moir M, Liberman AS, Feinberg S, Hayden DM, Chadi SA, Demyttenaere S, Samuel L, Hotakorzian N, Quintin L, Morin N, Faria J, Ghitulescu G, Vasilevsky CA, Boutros M; Bowel Stimulation Research Collaborative. Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial. Surg Endosc. 2023 May;37(5):3934-3943. doi: 10.1007/s00464-022-09510-5. Epub 2022 Aug 19.
- Individual participant dataSharing planned: No. No plan to share IPD due to privacy concerns and restrictions related to the informed consent provided by participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis Asensio, Consultant principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Ileus and Colorectal Cancer Control and Prevention, run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Dr. Asensio Gómez, Consultant (+34 650675894, lasensio@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LOS (time frame: 30 days after reconstructive surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06974500, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.