AzTrials
AzTrials

Rectal CancerNCT04455945

Quality of Life After Rectal Cancer Surgery

An observational study of Rectal Cancer and Quality of Life, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Following colorectal surgery, many patients face a combination of physical and emotional problems for a long period of time. Symptoms such as pain, fatigue, and disturbed bowel and sexual function, as well as problems in social and role functioning, inevitably affect the patients' well-being. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rectal Cancer, Quality of Life
What is being tested?
Open Rectal cancer surgery and Laparoscopic Rectal cancer surgery
Type of treatment
Surgery or procedure
How many people
2 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2017to 19 Jun 2020
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The patients who underwent surgery (laparoscopic or open) for rectal cancer in our department.

Who may be able to join

  • patients who underwent surgery (laparoscopic or open) for rectal cancer in our department.

Who cannot join

  • The patients whose all oncological treatments had not been completed at least 6 months ago
  • The patients with ASA IV score
  • The patients with previous abdominal surgery
  • The patients who had developed major surgical complications (such as anastomosis leakage, requiring re-laparotomy, evisceration)
  • The patients who underwent a new abdominal surgery except for stoma closure
  • The patients with local recurrence or distant metastases
Show all 9Show fewer
  • The patients who still had a stoma
  • The patients who did not want to take part in the study
  • The patients who missed in the follow-up period

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Kartal Dr Lutfi Kirdar Tranining and Research Hospital

    Istanbul, 34890

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Quality of Life Outcomes Between Laparoscopic and Open Approach for Rectal Cancer Surgery

Following colorectal surgery, many patients face a combination of physical and emotional problems for a long period of time. Symptoms such as pain, fatigue, and disturbed bowel and sexual function, as well as problems in social and role functioning, inevitably affect the patients' well-being. Therefore, evaluation of the self-reported quality of life (QoL) is becoming increasingly important in clinical trials. The investigators aimed to compare long term health related life quality (HRQoL) results of laparoscopic approach with open approach in patients with sphincter preserving resections for rectal cancer at a single-center.

Read the detailed description

This study is planned prospectively. All patients scheduled for operation due to rectal cancer in our clinic between January 2017 and December 2018 will be evaluated for suitability for the study. During the preoperative examination, patients will be informed about the study and their written consent will be obtained. Patients will be randomized between open and laparoscopic groups in the ratio 2:1, depending on the type of surgery. Clinical data of patients will be analyzed from the hospital database programme.

The EORTC QLQ-C30 and QLQ-CR29 questionnaires prepared by The European Organization for Research and Treatment of Cancer (EORTC) will be used to evaluate the quality of life after the operation. The EORTC QLQ-C30 questionnaire will be completed by examining the patients' daily observation notes. EORTC QLQ-CR29 will be completed with face to face interviews in the first year after surgery.

In this way, it will be aimed to compare the early and long-term quality of life (HRQoL) results of open and laparoscopic approach in patients undergoing surgery for rectal cancer.

Being tested
Open Rectal cancer surgery, Laparoscopic Rectal cancer surgery
Keywords
rectal cancer surgery, life quality, questionnaire
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open Rectal cancer surgeryProcedure or surgery

    Open sphincter preserving surgery for rectal cancer

  • Laparoscopic Rectal cancer surgeryProcedure or surgery

    Laparoscopic sphincter preserving surgery for rectal cancer

Study groups in NCT04455945
Study groupRoleWhat they receive
OpenPatients with open surgery for rectal cancer planned in our department.
Receives: Procedure: Open Rectal cancer surgery
LaparoscopicPatients with laparoscopic surgery for rectal cancer planned in our department.
Receives: Procedure: Laparoscopic Rectal cancer surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age

    Years

    Measured: Before surgery

  2. Gender

    Male/Female

    Measured: Before surgery

  3. BMI

    kg/m²

    Measured: Before surgery

  4. ASA

    I, II, III, IV

    Measured: Before surgery

  5. Tumor Localization

    Upper/Middle/Low

    Measured: During the operation

  6. Pathologic Stage

    1A, 1B, 2A, 2B, 3A, 3B, 3C

    Measured: up to 10 days after surgery

  7. Complications

    yes/no

    Measured: Through study completion, an average of 1 year

  8. European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Functional scales

    Global/Physical/Role/Cognitive/Social functioning. All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning.

    Measured: During one week after surgery

  9. European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Symptom scales

    Fatigue/Nausea and vomiting/Pain/Dyspnoea/Insomnia/Appetite loss/Constipation/Diarrhoea/Financial difficulties. All scales and single-item measurements range from 0 to 100. A higher score for a symptom scale / item indicates a higher symptomatology and problem level.

    Measured: During one week after surgery

  10. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Functional scales

    Body Image/Future projections/Weight/Sexual interest. All scales and single-item measurements range from 0 to 100. A higher score on a functional scale indicates better functioning.

    Measured: During one year after surgery

  11. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Symptom scales

    Urinary frequency/Blood and mucus in stool/Stool frequency/Urinary incontinence/Dysuria/Abdominal pain/Buttock pain/Bloating/Dry mouth/Hair loss/Taste/Flatulence/Faecal incontinence/Sore skin/Embarrassment/Impotence/Dyspareunia. All scales and single-item measurements range from 0 to 100. A higher score for a symptom scale / item indicates a higher symptomatology and problem level.

    Measured: During one year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2020
  2. Study start1 Jan 2017
  3. Primary completion31 Dec 2018
  4. Study completion19 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04455945
Sponsor's protocol ID
2017/514/108/12
Status last verified
Jul 2020
First submitted
19 Jun 2020
Last updated
2 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andersson J, Angenete E, Gellerstedt M, Angeras U, Jess P, Rosenberg J, Furst A, Bonjer J, Haglind E. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial. Br J Surg. 2016 Nov;103(12):1746. doi: 10.1002/bjs.10280. Epub 2016 Jul 6. No abstract available.

    PubMed 27801927

  • D'Ambrosio G, Paganini AM, Balla A, Quaresima S, Ursi P, Bruzzone P, Picchetto A, Mattei FI, Lezoche E. Quality of life in non-early rectal cancer treated by neoadjuvant radio-chemotherapy and endoluminal loco-regional resection (ELRR) by transanal endoscopic microsurgery (TEM) versus laparoscopic total mesorectal excision. Surg Endosc. 2016 Feb;30(2):504-511. doi: 10.1007/s00464-015-4232-8. Epub 2015 Jun 5.

    PubMed 26045097

  • D'Ambrosio G, Picchetto A, Campo S, Palma R, Panetta C, De Laurentis F, La Rocca S, Lezoche E. Quality of life in patients with loco-regional rectal cancer after ELRR by TEM versus VLS TME after nChRT: long-term results. Surg Endosc. 2019 Mar;33(3):941-948. doi: 10.1007/s00464-018-6583-4. Epub 2018 Nov 12.

    PubMed 30421081

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Cancer and Quality of Life, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age (time frame: Before surgery). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04455945, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in