Rectal NeoplasmTURNBULL-BCNNCT01766661
Prospective Multicenter Randomized Controlled Trial On Two-Stage Turnbull-Cutait Coloanal Anastomosis For Rectal
A study testing Hand-sewn coloanal anastomosis, Two staged Turnbull-Cutait procedure and Ultralow anterior rectal resection with total mesorectal excision in people with Rectal Neoplasm, run by Hospital Universitari de Bellvitge at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Rectal Neoplasm
- What is being tested?
- Hand-sewn coloanal anastomosis, Two staged Turnbull-Cutait procedure and Ultralow anterior rectal resection with total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2013to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites
Vall d'Hebron Universitary Hospital
Barcelona, 08035
Bellvitge University Hospital
Barcelona, 08907
Corporació Sanitària Parc Taulí Hospital Universitari
Sabadell, Barcelona
Italy1 site
Istituto Nazionale Tumori "Fondazione G, Pascale" - IRCCS
Naples, 80131
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Rectal Neoplasm
- Being tested
- Hand-sewn coloanal anastomosis, Two staged Turnbull-Cutait procedure, Ultralow anterior rectal resection with total mesorectal excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-sewn coloanal anastomosisProcedure or surgery
After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.
Two staged Turnbull-Cutait procedureProcedure or surgery
After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.
Ultralow anterior rectal resection with total mesorectal excisionProcedure or surgery
Standard ultralow anterior rectal resection with total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| Coloanal anastomosis with ileostomy | Active comparator | Hand-sewn coloanal anastomosis protected by a loop ileostomy Receives: Procedure: Hand-sewn coloanal anastomosis; Procedure: Ultralow anterior rectal resection with total mesorectal excision |
| Two stage Turnbull-Cutait anastomosis | Experimental | Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure). Receives: Procedure: Two staged Turnbull-Cutait procedure; Procedure: Ultralow anterior rectal resection with total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative morbidity
Measured: within the first 30 days after surgery
Secondary outcomes (3)
Quality of life
by COREFO questionnaire.
Measured: 3 years
Fecal incontinence
by Wexner Incontinence Score
Measured: 3 years
local and/or distant recurrence of neoplasm
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2019 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastiano Biondo, Hospital Universitari de Bellvitge
- Investigators
- Sebastiano Biondo, MD, Phd, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766661
- Sponsor's protocol ID
- TURNBULL-BCN-01
- Other IDs
- PR174/11
- Acronym
- TURNBULL-BCN
- Status last verified
- Feb 2019
- First submitted
- 10 Jan 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Biondo S, Barrios O, Trenti L, Espin E, Bianco F, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Long-Term Results of 2-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2024 Sep 1;159(9):990-996. doi: 10.1001/jamasurg.2024.2262.
PubMed 38985480Biondo S, Trenti L, Espin E, Bianco F, Barrios O, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):e201625. doi: 10.1001/jamasurg.2020.1625. Epub 2020 Aug 19.
PubMed 32492131Biondo S, Trenti L, Galvez A, Espin-Basany E, Bianco F, Romano G, Kreisler E; Turnbull-BCN study group. Two-stage Turnbull-Cutait pull-through coloanal anastomosis versus coloanal anastomosis with protective loop ileostomy for low rectal cancer. Protocol for a randomized controlled trial (Turnbull-BCN). Int J Colorectal Dis. 2017 Sep;32(9):1357-1362. doi: 10.1007/s00384-017-2842-4. Epub 2017 Jun 30.
PubMed 28667499
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01766661
- Acronym / sponsor ID
- TURNBULL-BCN / TURNBULL-BCN-01
- Conditions
- Rectal Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coloanal anastomosis with ileostomy | Active comparator | Procedure: Hand-sewn coloanal anastomosis, Procedure: Ultralow anterior rectal resection with total mesorectal excisionHand-sewn coloanal anastomosis protected by a loop ileostomy |
| Two stage Turnbull-Cutait anastomosis | Experimental | Procedure: Two staged Turnbull-Cutait procedure, Procedure: Ultralow anterior rectal resection with total mesorectal excisionTwo staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure). |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand-sewn coloanal anastomosisAfter low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy. | Procedure or surgery | Coloanal anastomosis with ileostomy |
| Two staged Turnbull-Cutait procedureAfter low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy. | Procedure or surgery | Two stage Turnbull-Cutait anastomosis |
| Ultralow anterior rectal resection with total mesorectal excisionStandard ultralow anterior rectal resection with total mesorectal excision | Procedure or surgery | Coloanal anastomosis with ileostomy, Two stage Turnbull-Cutait anastomosis |
Primary outcome
post-operative morbidity
Time frame: within the first 30 days after surgery
3 secondary outcomes
Quality of life
Time frame: 3 years
Fecal incontinence
Time frame: 3 years
local and/or distant recurrence of neoplasm
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 38985480Biondo S, Barrios O, Trenti L, Espin E, Bianco F, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Long-Term Results of 2-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2024 Sep 1;159(9):990-996. doi: 10.1001/jamasurg.2024.2262.
- Derived from this study: PubMed 32492131Biondo S, Trenti L, Espin E, Bianco F, Barrios O, Falato A, De Franciscis S, Solis A, Kreisler E; TURNBULL-BCN Study Group. Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Low Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):e201625. doi: 10.1001/jamasurg.2020.1625. Epub 2020 Aug 19.
- Derived from this study: PubMed 28667499Biondo S, Trenti L, Galvez A, Espin-Basany E, Bianco F, Romano G, Kreisler E; Turnbull-BCN study group. Two-stage Turnbull-Cutait pull-through coloanal anastomosis versus coloanal anastomosis with protective loop ileostomy for low rectal cancer. Protocol for a randomized controlled trial (Turnbull-BCN). Int J Colorectal Dis. 2017 Sep;32(9):1357-1362. doi: 10.1007/s00384-017-2842-4. Epub 2017 Jun 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastiano Biondo, MD, Phd principal investigator
Hospital Universitari de Bellvitge
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-sewn coloanal anastomosis, Two staged Turnbull-Cutait procedure and Ultralow anterior rectal resection with total mesorectal excision in people with Rectal Neoplasm, run by Hospital Universitari de Bellvitge at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative morbidity (time frame: within the first 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01766661, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.