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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04829032
Other study ID # 1244
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date May 31, 2022

Study information

Verified date March 2021
Source Parma University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hartmann's procedure was described for the first time in 1921 as an alternative to abdominoperineal resection for the treatment of upper rectal tumours. Although Hartmann's procedure fell out of favour for rectal cancer after the introduction of restorative procedures, it remained the most common procedure in emergency setting for many years. Nowadays Hartmann's procedure is a useful procedure in selected cases e.g. severely ill patients with a high risk of anastomotic failure. However, restoring intestinal continuity for Hartmann patients is often associated with high morbidity, and about 70% will live with a permanent colostomy. Hartmann procedure' is a rapid and simple surgical technique intended to decrease perioperative morbidity and mortality. This technique is often performed by young surgeons Indeed, end colostomy may be necessary in situations where restoration of continuity is risky, either because of unfavorable local conditions or because a more definitive resection must be aborted due to hemodynamic instability. In the last decade the Hartmann's procedure has been revalued in many studies. In diverticular disease the results of DIVA arm of the LADIES trial showed that more patients in the primary anastomosis group were stoma free compared with patients in the Hartmann's procedure group. Other studies have observed no differences in major postoperative complications or postoperative mortality between patients undergoing primary anastomosis versus Hartmann's procedure. Hartmann's procedure reversals were associated with a higher risk of serious postoperative complications than were stoma reversals after primary anastomosis with ileostomy. Despite the growing evidence in favour of primary anastomosis and its inclusion as a valid treatment option for perforated diverticulitis or perforated sigmoid colon in recent clinical practice guidelines, some surgeons have been hesitant to undertake anastomosis in the setting of purulent or faecal contamination and continue to choose Hartmann's procedure to eliminate concerns about anastomotic leakage.


Description:

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Study Design


Intervention

Procedure:
Hartmann's procedure
Hartmann's procedure

Locations

Country Name City State
Italy Mario Giuffrida Parma Italia

Sponsors (3)

Lead Sponsor Collaborator
Parma University Hospital Fausto Catena, Gennaro Perrone

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Hartmann's procedure vs colic resection with primary anastomosis performed in 3-months in urgent or emergency setting for left-sided acute colonic diseases. Etiology: perforated diverticulitis; perforated colonic cancer; large bowel perforation- obstruction; colon cancer perforation-obstruction; colon ischemia; abdominal trauma.
Treatment: Hartmann's procedure, colonic resection with primary anastomosis with or without diverting stoma, stoma without colic resection.
3 months
Secondary Risk factors that contribute in the choice of Hartmann's procedure instead of colon resection with primary anastomosis - Hospital Characteristics: hospital type (academic, non-academic teaching, categorical, secondary hospital, tertiary hospital, level 4- trauma center); annual volume of
emergency surgical procedures; annual volume of left-sided colonic disease; types of diagnostic and treatment modalities that are available in the hospital.
Surgeon experience (surgeon in training: less than 50 colorectal resections performed; less than 5 resections per year in the last 5 years; Trained surgeon: more than 50 colorectal resections performed; more than 10 resections per year in the last 5 years)
Time of surgery: weekdays, weekend, public holidays, night shift (day: 8am- 8pm; night: 8pm-8am)
3 months
Secondary The number of patients treated with Hartmann's procedure with a permanent stoma after one year. 1 year follow up to evaluate the number of patients treated with Hartmann's procedure have a permanent stoma after one year. 1 year
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