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

NCT06863896 | Not Yet Recruiting DMC

• 1 other identifier: v 1.0 del 01/01/2025
• Study Type: observational
• Target: 201
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colostomy - Stoma

Keywords

colostomy; hartmann

Outcome Measures

Primary Outcomes (1)

• average post-operative hospital stay

  from the day of surgery to the the day of discharge from the hospital ( up to 10 days)

Study Arms (1)

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

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

Procedure: Hartmann's reversal

Interventions

Hartmann's reversal PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnancy or lactation

Sponsors & Collaborators

• Azienda USL Toscana Centro: lead

Central Study Contacts

Carla Vaccaro, Consultant Surgeon

CONTACT

+393489237016; mscarla.vaccaro@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Carla Vaccaro

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 7, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE