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

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.

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Key information

Conditions

Colostomy - Stoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Hartmann's reversal

Procedure

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

Primary outcomes

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Carla Vaccaro, Consultant Surgeon

CONTACT

[email protected]

+393489237016

Sponsors and collaborators

Lead sponsor

Azienda USL Toscana Centro

Other

Registry information

Official study title

Laparoscopic Hartmann's Reversal Procedure ( LHarSal Study)

Acronym: LHarSAL

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 7, 2025
Registry last updated: Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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