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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 92
- Locations
- 7
- Primary Endpoint
- post-operative morbidity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Coloanal anastomosis with ileostomy
Hand-sewn coloanal anastomosis protected by a loop ileostomy
Intervention: Hand-sewn coloanal anastomosis (Procedure)
Coloanal anastomosis with ileostomy
Hand-sewn coloanal anastomosis protected by a loop ileostomy
Intervention: Ultralow anterior rectal resection with total mesorectal excision (Procedure)
Two stage Turnbull-Cutait anastomosis
Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).
Intervention: Two staged Turnbull-Cutait procedure (Procedure)
Two stage Turnbull-Cutait anastomosis
Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure).
Intervention: Ultralow anterior rectal resection with total mesorectal excision (Procedure)
Outcomes
Primary Outcomes
post-operative morbidity
Time Frame: within the first 30 days after surgery
Secondary Outcomes
- local and/or distant recurrence of neoplasm(3 years)
- Quality of life(3 years)
- Fecal incontinence(3 years)
Investigators
Sebastiano Biondo
PhD, MD
Hospital Universitari de Bellvitge