GOODBYE HARTMANN TRIAL: 100 YEARS OF HARTMANN'S PROCEDURE

NCT04829032 | Unknown DMC

• 1 other identifier: 1244
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergencies; Colon Disease; Colo-rectal Cancer; Volvulus Colon; Intussusception; Diverticulitis; Foreign Bodies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Risk factors that contribute in the choice of Hartmann's procedure instead of colon resection with primary anastomosis

  3 months

• The number of patients treated with Hartmann's procedure with a permanent stoma after one year.

  1 year

Study Arms (2)

Hartmann's procedure

Evaluate the role of Hartmann's procedure in emergency setting for left-sided acute surgical colonic disease (perforated diverticulitis with purulent or fecal peritonitis; colon cancer perforation-obstruction; ischemic colitis; abdominal trauma).

Procedure: Hartmann's procedure

Colonic resection with primary anastomosis

Evaluate the role of colonic resection with primary anastomosis in emergency setting for left-sided acute surgical colonic disease (perforated diverticulitis with purulent or fecal peritonitis; colon cancer perforation-obstruction; ischemic colitis; abdominal trauma).

Interventions

Hartmann's procedure PROCEDURE

Hartmann's procedure

Hartmann's procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive adult patients with left-sided colonic disease who have been operated in urgent-emergency setting between March -May 2021 will be prospectively analyzed and evaluated time of surgery, patient's characteristic, hospital's characteristics. All patients who have been operated in urgent-emergency setting for left-sided colonic disease are suitable for inclusion.

You may qualify if:

• Aged 18 years or older;
• Patients admitted in Emergency setting for left-sided colonic disease (perforated diverticulitis with purulent or fecal peritonitis; large bowel perforation-obstruction; colon cancer perforation-obstruction; ischemic colitis; abdominal trauma).
• Patients who underwent urgent or emergency surgery for left-sided colonic disease (perforated diverticulitis with purulent or fecal peritonitis; large bowel perforationobstruction; colon cancer perforation-obstruction; ischemic colitis; abdominal trauma).

You may not qualify if:

• Aged 17 or younger.
• Elective surgery.
• Non-surgical treatment.
• Patients with personal history of colorectal cancer treated surgically.
• Patients with stoma.
• Unstable patients who benefited of damage control procedures.

Sponsors & Collaborators

• Parma University Hospital: lead
• Fausto Catena: collaborator
• Gennaro Perrone: collaborator

Study Sites (1)

Mario Giuffrida

Parma, Italia, 43125, Italy

RECRUITING

MeSH Terms

Conditions

Emergencies; Colonic Diseases; Colonic Neoplasms; Intussusception; Diverticulitis; Foreign Bodies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Intestinal Obstruction; Diverticular Diseases; Gastroenteritis; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD- General Surgery Resident

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 2, 2021
• Study Start: March 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2022
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)