Colostomy - StomaLHarSALNCT06863896
Laparoscopic Hartmann's Reversal Procedure: In the Absence of Standardized Guidelines, we Started a Database of Patient Submitted Reversal Hartman With Standard Technique and Laparoscopic Technique, Prospectively for One Year and a Follow-up Period of 6 Months
An observational study of Colostomy - Stoma, run by Azienda USL Toscana Centro.
Trial summary
Several studies have shown laparoscopic technique's advantages, including more rapid post-operative recovery, less post-operative pain, earlier restoration of bowel function, more rapid return to normal diet, and reduced morbidity but it could still remain a complicated operation due to adhesions and difficulty in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colostomy - Stoma
- What is being tested?
- Hartmann's reversal
- Type of treatment
- Surgery or procedure
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2026
- How long will I take part?
- 6 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes all consecutive adult patients (≥18 years of age) underwent Hartmann's reversal procedure (open or laparoscopic procedure) in the participating centers. The decision to perform HR is based on the patients' preference and the attending surgeons' opinion and experience, after evaluating their clinical condition.
Who may be able to join
- Patients of both sexes, ≥ 18 years old.
- Patients who underwent Hartmann procedure for diverticulitis, intestinal ischemia or trauma
- Patients who may face a one-year follow-up.
- Patients fit for surgery.
Who cannot join
- age < 18.
- patients that have undergone Hartmann's procedure for cancer and also post-Hartmann adjuvant radiotherapy or residual neoplastic disease.
- immunodepression condition (patients undergoing chemo-radiotherapy and/or immunotherapy, patients undergoing immunosuppressive therapy for autoimmune diseases or transplants, cirrhotic class C and D patients, patients with chronic renal failure undergoing dialysis treatment.)
- patients with missing data
- Pregnancy or lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Laparoscopic Hartmann's Reversal Procedure ( LHarSal Study)
Several studies have shown laparoscopic technique's advantages, including more rapid post-operative recovery, less post-operative pain, earlier restoration of bowel function, more rapid return to normal diet, and reduced morbidity but it could still remain a complicated operation due to adhesions and difficulty in identifying the rectal stump. Nevertheless, nowadays laparoscopic technique has largely become part of clinical practice even for younger surgeons. Assumed this, and in the lack of prospective studies, we aimed to confirm the advantages of laparoscopic Hartmann reversal (LHR) by confirming the difference in peri-operative outcomes and postoperative complications.
In clinical practice, the first question to be asked is whether there is a right timing for a patient to undergo Hartmann's reversal procedure and whether timing influences the incidence of complications (short-terms and long-terms outcomes). Another aim of the study is to investigate if the length of rectal stump influences the outcome of Hartmann's reversal surgery.
- Conditions
- Colostomy - Stoma
- Being tested
- Hartmann's reversal
- Keywords
- colostomy, hartmann
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hartmann's reversalProcedure or surgery
Colostomy reversal with laparoscopic technique after Hartmann's procedure ( procto-sigmoidectomy with end colostomy)
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing Reversal Hartmann's procedure with open or laparoscopic technique | The study population includes all consecutive adult patients (≥18 years of age) underwent Hartmann's reversal procedure (open or laparoscopic procedure) in the participating centers Receives: Procedure: Hartmann's reversal |
What is being measured
The primary outcome is the main question the study is designed to answer.
average post-operative hospital stay
Measured: from the day of surgery to the the day of discharge from the hospital ( up to 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy - StomaStudies 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
- 201 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Centro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Vaccaro, Azienda USL Toscana Centro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863896
- Sponsor's protocol ID
- v 1.0 del 01/01/2025
- Acronym
- LHarSAL
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary outcomes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Hartmann's Reversal Procedure ( LHarSal Study)
- ClinicalTrials.gov ID
- NCT06863896
- Acronym / sponsor ID
- LHarSAL / v 1.0 del 01/01/2025
- Conditions
- Colostomy - Stoma
- Keywords
- colostomy, hartmann
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Azienda USL Toscana CentroUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Mar 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.
Several studies have shown laparoscopic technique's advantages, including more rapid post-operative recovery, less post-operative pain, earlier restoration of bowel function, more rapid return to normal diet, and reduced morbidity but it could still remain a complicated operation due to adhesions and difficulty in identifying the rectal stump. Nevertheless, nowadays laparoscopic technique has largely become part of clinical practice even for younger surgeons. Assumed this, and in the lack of prospective studies, we aimed to confirm the advantages of laparoscopic Hartmann reversal (LHR) by confirming the difference in peri-operative outcomes and postoperative complications.
In clinical practice, the first question to be asked is whether there is a right timing for a patient to undergo Hartmann's reversal procedure and whether timing influences the incidence of complications (short-terms and long-terms outcomes). Another aim of the study is to investigate if the length of rectal stump influences the outcome of Hartmann's reversal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing Reversal Hartmann's procedure with open or laparoscopic technique | – | Procedure: Hartmann's reversalThe study population includes all consecutive adult patients (≥18 years of age) underwent Hartmann's reversal procedure (open or laparoscopic procedure) in the participating centers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes all consecutive adult patients (≥18 years of age) underwent Hartmann's reversal procedure (open or laparoscopic procedure) in the participating centers. The decision to perform HR is based on the patients' preference and the attending surgeons' opinion and experience, after evaluating their clinical condition.
Key inclusion criteria (4 listed)
- Patients of both sexes, ≥ 18 years old.
- Patients who underwent Hartmann procedure for diverticulitis, intestinal ischemia or trauma
- Patients who may face a one-year follow-up.
- Patients fit for surgery.
Key exclusion criteria (5 listed)
- age < 18.
- patients that have undergone Hartmann's procedure for cancer and also post-Hartmann adjuvant radiotherapy or residual neoplastic disease.
- immunodepression condition (patients undergoing chemo-radiotherapy and/or immunotherapy, patients undergoing immunosuppressive therapy for autoimmune diseases or transplants, cirrhotic class C and D patients, patients with chronic renal failure undergoing dialysis treatment.)
- patients with missing data
- Pregnancy or lactation
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 |
|---|---|---|
| Hartmann's reversalColostomy reversal with laparoscopic technique after Hartmann's procedure ( procto-sigmoidectomy with end colostomy) | Procedure or surgery | patients undergoing Reversal Hartmann's procedure with open or laparoscopic technique |
Primary outcome
average post-operative hospital stay
Time frame: from the day of surgery to the the day of discharge from the hospital ( up to 10 days)
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 7 Mar 2025.
- Individual participant dataSharing planned: Yes. Primary outcomes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colostomy - Stoma, run by Azienda USL Toscana Centro.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Carla Vaccaro, Consultant Surgeon (+393489237016, mscarla.vaccaro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average post-operative hospital stay (time frame: from the day of surgery to the the day of discharge from the hospital ( up to 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2025.