Clinical trial NCT06863896: 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
Official title: Laparoscopic Hartmann's Reversal Procedure ( LHarSal Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colostomy - Stoma
Keywords: colostomy
hartmann
Lead sponsor: Azienda USL Toscana Centro
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: average post-operative hospital stay
timeFrame: from the day of surgery to the the day of discharge from the hospital ( up to 10 days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: