Know Cancer

or
forgot password

Prospective Multicenter Randomized Controlled Trial Comparing Postoperative Complications and Quality of Life in Low Rectal Cancer Surgery Between Coloanal Anastomosis and Lateral Ileostomy Versus Two-Stage Turnbull-Cutait Coloanal Anastomosis


N/A
18 Years
74 Years
Open (Enrolling)
Both
Rectal Neoplasm

Thank you

Trial Information

Prospective Multicenter Randomized Controlled Trial Comparing Postoperative Complications and Quality of Life in Low Rectal Cancer Surgery Between Coloanal Anastomosis and Lateral Ileostomy Versus Two-Stage Turnbull-Cutait Coloanal Anastomosis


Anastomotic leak represents the most frequent complication after rectal cancer surgery and a
lateral covering ileostomy is usually performed to reduce its incidence. Other important
consequences of rectal cancer surgery are alterations in bowel habits and function and a
negative impact on quality of life. This prospective, randomized, multicenter and controlled
trial compares post-operative complications, quality of life, faecal incontinence and
recurrence rate in patients treated for low rectal cancer with colo-anal anastomosis
protected by a lateral ileostomy or with a two-staged Turnbull-Cutait colo-anal anastomosis.


Inclusion Criteria:



- Patients with adenocarcinoma of the lower-middle third of the rectum proctoscopy
established by rigid proctoscopy, with histological confirmation and candidates of
colo-anal anastomosis;

- Patients over 18 years and under 75 years, who can tolerate neoadjuvant and surgical
treatment;

- Patients who undergo an ultra-low anterior rectal resection with total mesorectal
excision and nerve and sphincter-sparing with curative intention

- Any extension of the primary tumor (T 1-2-3-4) according to the TNM classification;

- Patients with or without lymph node metastasis (N - / +) and with or without
resectable distant metastases;

- Patients clinically without fecal incontinence prior to the current illness and with
a Wexner incontinence Score less than or equal to 5;

- Patients ASA I, II or III and adequate hematological, renal and hepatic function;

- Patients who signed informed consent.

Exclusion Criteria:

- Altered cognitive state(eg mental retardation or dementia) that prevents
collaboration in the study or patients who can neither read nor write

- Fecal incontinence (Wexner equal to or greater than 6);

- Previous surgery or proctological, colonic and anorectal functional disease

- Diagnosis of synchronous colorectal or any other active neoplasm;

- Patients ASA IV, V;

- Pregnancy and lactation;

- Rejection of the patient to sign the consent form.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

post-operative morbidity

Outcome Time Frame:

within the first 30 days after surgery

Safety Issue:

Yes

Principal Investigator

Esther Kreisler Moreno, MD, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Bellvitge University Hospital

Authority:

Spain: Ethics Committee

Study ID:

TURNBULL-BCN-01

NCT ID:

NCT01766661

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Rectal Neoplasm
  • Neoplasms
  • Postoperative Complications
  • Rectal Neoplasms

Name

Location