Quality of Life After Rectal Cancer Surgery

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455945
• Other study ID #: 2017/514/108/12
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: June 19, 2020

Study information

• Verified date: July 2020
• Source: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 19, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Quality of Life
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Open Rectal cancer surgery
Open sphincter preserving surgery for rectal cancer
• Laparoscopic Rectal cancer surgery
Laparoscopic sphincter preserving surgery for rectal cancer

Locations

Country	Name	City	State
Turkey	Kartal Dr Lutfi Kirdar Tranining and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Andersson J, Angenete E, Gellerstedt M, Angerås U, Jess P, Rosenberg J, Fürst 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Years	Before surgery
Primary	Gender	Male/Female	Before surgery
Primary	BMI	kg/m²	Before surgery
Primary	ASA	I, II, III, IV	Before surgery
Primary	Tumor Localization	Upper/Middle/Low	During the operation
Primary	Pathologic Stage	1A, 1B, 2A, 2B, 3A, 3B, 3C	up to 10 days after surgery
Primary	Complications	yes/no	Through study completion, an average of 1 year
Primary	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.	During one week after surgery
Primary	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.	During one week after surgery
Primary	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.	During one year after surgery
Primary	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.	During one year after surgery