Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study

Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study

Ver estudio completo en Inglés
Patrocinadores

Patrocinador principal: Region Västmanland

Fuente Region Västmanland
Resumen breve

In patients with rectal cancer, an anterior resection with a colo-rectal or colo-anal anastomoses is the gold standard. However, in patients with a weak sphincter and fecal incontinence or in patients with severe co-morbidity and reduced general condition, this operation is not suitable.

In these situations there are two other radical surgical options, Hartmanns procedure and the Abdominoperineal excision that can be performed with intersphincteric dissection to minimise perineal complications.There are no data on which of these procedures that are best suited for these patients with fecal incontinence or severe co-morbidity( at risk for life-threatening anastomotic leak). In this randomized study we intend to compare postoperative complications within 30 days after these two procedures and also late complications and quality of life after one year postoperatively.

Descripción detallada

In patients with rectal cancer, an abdominal operation with anterior resection with total mesorectal excision is the gold standard. Colon is anastomosed to the ano-rectum.The potential risks are bad bowel function with fecal incontinence or a lifethreatening anastomotic dehiscence, especially in patients with severe co-morbidity or reduced general condition.Tumours in the low rectum are usually treated with an abdominoperineal resection where the whole anus is radically excised and a permanent colostomy is created.

For patients with incontinence and/or severe comorbidity, Hartmann´s procedure has often been performed. The rectum is resected, the lower part is transected with a stapler and a colostomy is created. During recent years there has been reports on high rates of pelvic abscesses after Hartmann´s. An alternative has been proposed, namely the abdominoperineal excision (APE) with intersphincteric dissection leaving the outer sphincter and levator muscles in place, thus creating a much lesser perineal wound that also tend to heal better when the ano-pelvic muscles are left in place.

There have been some small retrospective studies comparing postoperative complications after Hartmann´s with anterior resections or the classic abdominoperineal excision. These studies are heterogenous and not balanced and no conclusions can be drawn. There are no data on APE with intersphincteric dissection in rectal cancer patients.

There is a need to clarify what procedure is most suited for patients with rectal cancer and fecal incontinence and / or severe comorbidity.

For this patient group we intend to randomize between Hartmann´s procedure and APE with intersphincteric dissection.

Estado general Recruiting
Fecha de inicio February 2014
Fecha de Terminación February 2025
Fecha de finalización primaria February 2022
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Rates ot postoperative surgical complications within 30 days. 30 days
Resultado secundario
Medida Periodo de tiempo
Peroperative data day of surgery
The rate of intraoperative perforations day of surgery
Resection margins 2-4 weeks after surgery
Rate of local recurrence 3 and 5 years postoperatively
Survival after 3 and 5 years follow-up 3 and 5 years postoperativelly
Postoperative actions within 30 days
Other postop complications 30 days
Inscripción 340
Condición
  • Rectal Cancer
  • Sphincter Ani Incontinence
  • Other Diagnoses, Comorbidities, and Complications
Intervención

Tipo de intervención: Procedure

Nombre de intervención: APE with intersphincteric dissection

Descripción: Abdominal operation where the rectum is resected down to the levator and then the anus is resected by an intersphincteric dissection and order to leave the outer sfincter and levator in place to avoid a large wound and a high rate of infectious complications.

Etiqueta de grupo de brazo: Hartmann´s procedure

Tipo de intervención: Procedure

Nombre de intervención: Hartmann´s procedure

Descripción: Abdominal operation where the rectum is resected and stapled off distally and a stoma is created

Etiqueta de grupo de brazo: APE with intersphincteric dissection

Elegibilidad

Criterios:

Inclusion Criteria:

- Rectal cancer 5cm or more from the anal verge

- Both procedures should be possible to perform

- Patients should have co-morbidities and/or have weak anal sphincter where an anterior resection is not suitable

- Metastases are no contraindication but the procedure should be assessed as locally radical.

- Patients should be assesed to cope with a major abdominal procedure(ASA I-III)

Exclusion Criteria:

- rectal cancer below 5cm from the anal verge where a Hartmann is considered not to be locally radical.

- patients where an anterior resection is suitable

- ASA IV or worse

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Kenneth Smedh, PhD Principal Investigator Region Vastmanland
Contacto general

Apellido: Kenneth Smedh, PhD

Teléfono: +46-70-3735576

Email: [email protected]

Ubicación
Instalaciones: Estado: Investigador: Västmanlands Hospital Västerås Kenneth Smedh, PhD Principal Investigator
Ubicacion Paises

Sweden

Fecha de verificación

March 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Region Västmanland

Nombre completo del investigador: Kenneth Smedh

Título del investigador: Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: APE with intersphincteric dissection

Tipo: Active Comparator

Descripción: Abdominoperineal excision with intersphincteric dissection and a stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity

Etiqueta: Hartmann´s procedure

Tipo: Active Comparator

Descripción: Hartmann´s operation and stoma is performed in patients with rectal cancer and fecal incontinence and/or severe co-morbidity

Acrónimo HAPIrect
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Source: ClinicalTrials.gov