Clinical trial NCT04455945: Quality of Life After Rectal Cancer Surgery
Official title: Comparison of Quality of Life Outcomes Between Laparoscopic and Open Approach for Rectal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Quality of Life
Keywords: rectal cancer surgery
life quality
questionnaire
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-07-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who underwent surgery (laparoscopic or open) for rectal cancer in our department.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Age
timeFrame: Before surgery
measure: Gender
timeFrame: Before surgery
measure: BMI
timeFrame: Before surgery
measure: ASA
timeFrame: Before surgery
measure: Tumor Localization
timeFrame: During the operation
measure: Pathologic Stage
timeFrame: up to 10 days after surgery
measure: Complications
timeFrame: Through study completion, an average of 1 year
measure: European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Functional scales
timeFrame: During one week after surgery
measure: European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Symptom scales
timeFrame: During one week after surgery
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Functional scales
timeFrame: During one year after surgery
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29) Symptom scales
timeFrame: During one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Dr Lutfi Kirdar Tranining and Research Hospital
Study officials:
affiliation: Kartal Dr. Lutfi Kirdar Training and Research Hospital
name: Selcuk Kaya, MD
role: STUDY_CHAIR
References:
citation: 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.
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.
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.