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CSAR Trial's aim is to determine whether the transverse coloplasty pouch or the side-to-end anastomosis as rectal reservoir reconstruction offers the best functional results.
This study directly compares two neorectal reservoir-techniques, the transverse coloplasty and the side-to-end anastomosis, in low anterior resection in distal rectal cancer for the first time. Its focus is on the functional results. Besides stool frequency, the quality of life, safety of the procedures and the usage of stool modulating drugs is monitored in an 12 months-follow up regime.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Side-to-End | Experimental | Side-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR) |
|
| Transverse Coloplasty | Active Comparator | Transverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Side-to-End Anastomosis | Procedure | During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a side-to-end colorectal anastomosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | Between group differences in stool frequency at t = 6 months postoperative | time = 6 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications |
| through study completion (an average of 12 months postoperative) |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Markus Rentsch, MD | Contact | 0049/89/4400/711213 | markus.rentsch@med.uni-muenchen.de | |
| Sandro M Hasenhütl, MD | Contact | 0049/89/4400/711242 | sandro.hasenhuetl@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Markus Rentsch, MD | Department of General, Visceral, and Transplantation Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria-Theresia-Klinik | Not yet recruiting | München | Bavaria | 80336 | Germany |
There is no plan to make individual participant data available to third parties beyond the study team.
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Study participants will be randomized in two parallel study arms regarding their neorectal reconstruction in low anterior resection, the experimental arm using the side-to-end anastomosis and the control group using the transverse coloplasty technique.
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There is no masking in the CSAR Trial
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|
| Transverse Coloplasty | Procedure | During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a transverse coloplasty pouch. For this purpose an end-to-end colorectal anastomosis is initially performed, followed by a longitudinal incision of approx. 8-10 cm length proximal of the anastomosis and a subsequent transverse suture in terms of the coloplasty technique. |
|
|
Quality of Life with focus on colorectally specialized questionnaires |
| baseline, postoperative (2-3 months, 6 months, 12 months) |
| Antimotility drug usage | Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires | baseline, postoperative (2-3 months, 6 months, 12 months) |
| Krankenhaus Barmherzige Brüder München | Not yet recruiting | München | Bavaria | 80639 | Germany |
|
| Klinikum der Universität München | Recruiting | München | Bavaria | 81377 | Germany |
|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D005242 | Fecal Incontinence |
| 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 |
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