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Sexual Function and Wellbeing in Males Diagnosed With Rectal Cancer

This study is ongoing, but not recruiting participants.
Swedish Cancer Society
Information provided by (Responsible Party):
Anna Martling, Karolinska Institutet Identifier:
First received: October 4, 2010
Last updated: February 25, 2016
Last verified: February 2016
Preoperative radiotherapy and pelvic surgery is recommended to many patients with rectal cancer. For men there are theoretical reasons to believe that the treatment may effect hormone levels, spermatogenesis, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where patients can choose to take part in one, two or three parts of the study. The three different parts are blood tests, questionnaires and semen samples.

Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Sexual function [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Hormone levels [ Time Frame: 2 years ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men with rectal cancer stadium I-III, planned for abdominal surgery with or without preoperative radiotherapy.

Inclusion Criteria:

  • Males diagnosed with rectal cancer stadium I-III, planned for surgery with or without preoperative radiotherapy

Exclusion Criteria:

  • Rectal cancer stadium IV
  • Previous radiotherapy to the pelvic region
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01216202

Gastrocentrum kirurgi, Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Swedish Cancer Society
  More Information

Responsible Party: Anna Martling, Associate Professor, Senior Consultant Surgeon, Karolinska Institutet Identifier: NCT01216202     History of Changes
Other Study ID Numbers: 2009/1860-31/2
Study First Received: October 4, 2010
Last Updated: February 25, 2016

Keywords provided by Karolinska Institutet:
Rectal cancer
Preoperative radiotherapy
Pelvic surgery
Sexual function
Hormone levels

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 21, 2017