Clinical trial · Observational
GOODBYE HARTMANN TRIAL: 100 YEARS OF HARTMANN'S PROCEDURE
GOODBYE HARTMANN. AFTER 100 YEARS HARTMANN'S PROCEDURE IS GOING TO BE ABANDONED?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Disease | — | UNRESOLVED | — |
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Diverticulitis | — | UNRESOLVED | — |
| Emergencies | — | UNRESOLVED | — |
| Foreign Bodies | — | UNRESOLVED | — |
| Intussusception | — | UNRESOLVED | — |
| Volvulus Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hartmann's procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hartmann's procedure
- description
- 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).
- interventionNames
- Procedure: Hartmann's procedure
- label
- Colonic resection with primary anastomosis
- description
- 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).
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available