Quality of Life After Rectal Cancer Surgery

NCT04455945 | Completed

• 1 other identifier: 2017/514/108/12
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer; Quality of Life

Keywords

rectal cancer surgery; life quality; questionnaire

Outcome Measures

Primary Outcomes (11)

• Age

  Years

  Before surgery

• Gender

  Male/Female

  Before surgery

• BMI

  kg/m²

  Before surgery

• ASA

  I, II, III, IV

  Before surgery

• Tumor Localization

  Upper/Middle/Low

  During the operation

• Pathologic Stage

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

  up to 10 days after surgery

• Complications

  yes/no

  Through study completion, an average of 1 year

• 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

• 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

• 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

• 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

Study Arms (2)

Open

Patients with open surgery for rectal cancer planned in our department.

Procedure: Open Rectal cancer surgery

Laparoscopic

Patients with laparoscopic surgery for rectal cancer planned in our department.

Procedure: Laparoscopic Rectal cancer surgery

Interventions

Open Rectal cancer surgery PROCEDURE

Open sphincter preserving surgery for rectal cancer

Open

Laparoscopic Rectal cancer surgery PROCEDURE

Laparoscopic sphincter preserving surgery for rectal cancer

Laparoscopic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr Lutfi Kirdar Tranining and Research Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 27801927 BACKGROUND

• 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.

  PMID: 26045097 BACKGROUND

• 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.

  PMID: 30421081 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Selcuk Kaya, MD

  Kartal Dr. Lutfi Kirdar Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: July 2, 2020
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: June 19, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)