Neoplasms

Blood and Lymph Conditions

All Conditions

Behaviors and Mental Disorders

Hematologic Neoplasms

Hematologic Diseases

Quality of Life

Mohamed L Sorror, MD; MSc

We are interested in studying whether and how medical problems other than primary cancer before hematopoietic cell transplantation would impact the profiles of quality of life and toxicities post-transplantation for patients with blood cancers. We want to see if by assessing comorbidities (such as diabetes) early on, we can identify those patients who will have more toxicities or limitations in their quality of life after transplant. The generated information could set the stage for future intervention studies aiming to improve quality of life for patients with blood cancers after transplantation.

Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life

Prospective Assessment of Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life

A 19-item instrument, it assesses physical symptoms and their interference with life.

A 49-item questionnaire measuring quality of life in bone marrow transplant patients, it measures physical, functional, social/family and emotional well-being in addition to bone marrow transplant-specific concerns.

This measure is used to measure utilities that can be used to calculate a quality adjusted survival score.

This measure captures the frequency and diversity of social activities outside of daily responsibilities.

This measures social support, including participation in social activities and perception of social support.

This is a 25-item scale assessing distress related to perceived demands from events specific to cancer survivors.

The PHQ-9 measures measures depression and parallels the nine diagnostic symptom criteria of the DSM-IV for Major Depressive Disorder.

We will measure toxicities using the NCI CTCAE

National Heart, Lung, and Blood Institute (NHLBI)

Fred Hutchinson Cancer Center

Infections

Symptoms and General Pathology

Digestive System Diseases

Communicable Diseases

Postoperative Complications

Fecal Incontinence

Abscess

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

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

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

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.

APE with intersphincteric dissection

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

Hartmann´s procedure

Kenneth Smedh, PhD

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.

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.

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

QoL protocol according to the QoLiRECT-study (Quality of life rectal cancer study) a study running from Gothenburg, Sweden

Perineal pain, secretion from the ano-rectal stump

Perineal and abdominal wound infection, pelvic abscess urinary catheter at discharge etc

time of surgery, bleeding in ml, peroperative complications, type of staplers used

record perforation of rectum or tumour during surgery

Record local recurrence during follow-up. CT-scan after 1 and 3 years

reoperation, interventions(percutaneous drains etc) hospital stay, rehospitalisation

other infectious, cardio-pulmonary and thromb-embolic complications.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life	NCT01930981	Hematologic Mal... Other Diagnoses...		19 Years -	Fred Hutchinson Cancer Center
Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study	NCT01995396	Rectal Cancer Sphincter Ani I... Other Diagnoses...	APE with inters... Hartmann´s proc...	18 Years -	Region Västmanland
Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life	NCT01930981	Hematologic Mal... Other Diagnoses...		19 Years -	Fred Hutchinson Cancer Center
Hartmanns Procedure or Abdominoperineal Excision With Intersphincteric Dissection in Rectal Cancer: a Randomized Study	NCT01995396	Rectal Cancer Sphincter Ani I... Other Diagnoses...	APE with inters... Hartmann´s proc...	18 Years -	Region Västmanland

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