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 (LHarSAL)

Azienda USL Toscana Centro

Status: Not yet enrolling

Conditions: Colostomy - Stoma

Treatments: Procedure: Hartmann's reversal

Study type: Observational

Funder types: Other

Identifiers

NCT06863896

v 1.0 del 01/01/2025

Details and patient eligibility

About

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.

Enrollment: 201 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

201 participants in 1 patient group

patients undergoing Reversal Hartmann's procedure with open or laparoscopic technique

Description:

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

Treatment:

Procedure: Hartmann's reversal