Rectal Neoplasm
Conditions
Brief summary
The aim of this study is to decrease the morbidity by 30% using the Turnbull-Cutait procedure in comparison to the standard surgery for low rectal cancer. The investigators compare quality of life, faecal incontinence and recurrence of neoplasm in patients who received standard colo-anal anastomosis with protective ileostomy or two-staged Turnbull-Cutait colo-anal anastomosis after Low Anterior Resection for rectal cancer.
Detailed description
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.
Interventions
PROCEDUREHand-sewn coloanal anastomosis
After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.
PROCEDURETwo staged Turnbull-Cutait procedure
After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.
PROCEDUREUltralow anterior rectal resection with total mesorectal excision
Standard ultralow anterior rectal resection with total mesorectal excision
Sponsors
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| post-operative morbidity | within the first 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 3 years | by COREFO questionnaire. |
| Fecal incontinence | 3 years | by Wexner Incontinence Score |
| local and/or distant recurrence of neoplasm | 3 years | — |
Countries
Italy, Spain
Outcome results
None listed