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NCT06863896: LHarSAL

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

Not yet recruiting Last updated 7 March 2025
What this trial tests

trial testing Hartmann's reversal in Colostomy - Stoma in 201 participants. Not yet recruiting.

Timeline
1 June 2025
Primary endpoint
30 June 2026
31 December 2026

Quick facts

Lead sponsorAzienda USL Toscana Centro
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment201
Start date1 June 2025
Primary completion30 June 2026
Estimated completion31 December 2026

Drugs / interventions tested

Conditions studied

Sponsor

Azienda USL Toscana Centro

Who can join

18 and older, any sex, with Colostomy - Stoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Colostomy - Stoma

Currently open trials in the same condition.

Other Azienda USL Toscana Centro trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06863896.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing