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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

Laparoscopic Hartmann's Reversal Procedure ( LHarSal Study)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06863896
Acronym
LHarSAL
Enrollment
201
Registered
2025-03-07
Start date
2025-06-01
Completion date
2026-12-31
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colostomy - Stoma

Keywords

colostomy, hartmann

Brief 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 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.

Interventions

PROCEDUREHartmann's reversal

Colostomy reversal with laparoscopic technique after Hartmann's procedure ( procto-sigmoidectomy with end colostomy)

Sponsors

Azienda USL Toscana Centro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Patients of both sexes, ≥ 18 years old. 2. Patients who underwent Hartmann procedure for diverticulitis, intestinal ischemia or trauma 3. Patients who may face a one-year follow-up. 4. Patients fit for surgery.

Exclusion criteria

1. age \< 18. 2. patients that have undergone Hartmann's procedure for cancer and also post-Hartmann adjuvant radiotherapy or residual neoplastic disease. 3. 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.) 4. patients with missing data 5. Pregnancy or lactation

Design outcomes

Primary

MeasureTime frame
average post-operative hospital stayfrom the day of surgery to the the day of discharge from the hospital ( up to 10 days)

Contacts

Primary ContactCarla Vaccaro, Consultant Surgeon
mscarla.vaccaro@gmail.com+393489237016

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026