Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PR174/11 | Other Identifier | CEIC Hospital Universitari de Bellvitge |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coloanal anastomosis with ileostomy | Active Comparator | Hand-sewn coloanal anastomosis protected by a loop ileostomy |
|
| Two stage Turnbull-Cutait anastomosis | Experimental | Two staged coloanal anastomosis without protective ileostomy (Turnbull-Cutait procedure). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand-sewn coloanal anastomosis | Procedure | After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy. |
| Measure | Description | Time Frame |
|---|---|---|
| post-operative morbidity | within the first 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | by COREFO questionnaire. | 3 years |
| Fecal incontinence | by Wexner Incontinence Score | 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sebastiano Biondo, MD, Phd | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Nazionale Tumori "Fondazione G, Pascale" - IRCCS | Naples | 80131 | Italy | |||
| Corporació Sanità ria Parc Taulà Hospital Universitari |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38985480 | Derived | 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. | |
| 32492131 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Two staged Turnbull-Cutait procedure | 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. |
|
| Ultralow anterior rectal resection with total mesorectal excision | Procedure | Standard ultralow anterior rectal resection with total mesorectal excision |
|
| local and/or distant recurrence of neoplasm | 3 years |
| Sabadell |
| Barcelona |
| Spain |
| Vall d'Hebron Universitary Hospital | Barcelona | 08035 | Spain |
| Bellvitge University Hospital | Barcelona | 08907 | Spain |
| Biondo 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. |
| 28667499 | Derived | Biondo 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. |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided