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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda USL Toscana Centro

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hartmann's reversal

    Procedure/Surgery

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

Treatment groups

201 Participants
are divided into 1 treatment group
Group A: patients undergoing Reversal Hartmann's procedure with open or laparoscopic technique1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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