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Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial (CSAR)

Primary Purpose

Rectal Cancer, Rectal Neoplasms, Rectal Tumors

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Side-to-End Anastomosis
Transverse Coloplasty
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Low Anterior Resection, Coloplasty Pouch, Side-to-end Anastomosis, Continence, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled low anterior resection in patients with distal rectal carcinoma and planned anastomosis in mid/distal third of rectum
  • Local curative approach
  • Normal continence preoperatively
  • Non-IBD-associated carcinoma
  • Possible sphincter salvage
  • Signed informed consent

Exclusion Criteria:

  • Non-curative approaches
  • Emergency surgery in cases of tumor perforation, abscess, sepsis
  • Proximal rectal carcinoma (> 12 cm from anocutaneous line)
  • Lack of informed consent
  • Age <18 years
  • Inclusion in other trials with interference of endpoints
  • Life expectancy less than 24 months (as estimated by the treating physicians)
  • Pregnancy
  • Immunosuppression

Sites / Locations

  • Maria-Theresia-Klinik
  • Krankenhaus Barmherzige Brüder München
  • Klinikum der Universität MünchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Side-to-End

Transverse Coloplasty

Arm Description

Side-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR)

Transverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR)

Outcomes

Primary Outcome Measures

Stool frequency
Between group differences in stool frequency at t = 6 months postoperative

Secondary Outcome Measures

Postoperative complications
Septic intraabdominal complications related to anastomosis (anastomotic insufficiencies, suture insufficiencies, abscesses); Wound infection
Quality of Life
Quality of Life with focus on colorectally specialized questionnaires
Antimotility drug usage
Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires

Full Information

First Posted
February 26, 2017
Last Updated
May 31, 2017
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT03074461
Brief Title
Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial
Acronym
CSAR
Official Title
Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Rectal Neoplasms, Rectal Tumors, Fecal Incontinence
Keywords
Rectal Cancer, Low Anterior Resection, Coloplasty Pouch, Side-to-end Anastomosis, Continence, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
There is no masking in the CSAR Trial
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Side-to-End
Arm Type
Experimental
Arm Description
Side-to-End Anastomosis as neorectal reconstruction technique in low anterior resection (LAR)
Arm Title
Transverse Coloplasty
Arm Type
Active Comparator
Arm Description
Transverse Coloplasty pouch as neorectal reconstruction technique in low anterior resection (LAR)
Intervention Type
Procedure
Intervention Name(s)
Side-to-End Anastomosis
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transverse Coloplasty
Other Intervention Name(s)
Coloplasty Pouch, Transverse Coloplasty Pouch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stool frequency
Description
Between group differences in stool frequency at t = 6 months postoperative
Time Frame
time = 6 months postoperative
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Septic intraabdominal complications related to anastomosis (anastomotic insufficiencies, suture insufficiencies, abscesses); Wound infection
Time Frame
through study completion (an average of 12 months postoperative)
Title
Quality of Life
Description
Quality of Life with focus on colorectally specialized questionnaires
Time Frame
baseline, postoperative (2-3 months, 6 months, 12 months)
Title
Antimotility drug usage
Description
Usage of antimotility drugs (e.g. loperamide) evaluated by standardized questionnaires
Time Frame
baseline, postoperative (2-3 months, 6 months, 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled low anterior resection in patients with distal rectal carcinoma and planned anastomosis in mid/distal third of rectum Local curative approach Normal continence preoperatively Non-IBD-associated carcinoma Possible sphincter salvage Signed informed consent Exclusion Criteria: Non-curative approaches Emergency surgery in cases of tumor perforation, abscess, sepsis Proximal rectal carcinoma (> 12 cm from anocutaneous line) Lack of informed consent Age <18 years Inclusion in other trials with interference of endpoints Life expectancy less than 24 months (as estimated by the treating physicians) Pregnancy Immunosuppression
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Rentsch, MD
Phone
0049/89/4400/711213
Email
markus.rentsch@med.uni-muenchen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Sandro M Hasenhütl, MD
Phone
0049/89/4400/711242
Email
sandro.hasenhuetl@med.uni-muenchen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Rentsch, MD
Organizational Affiliation
Department of General, Visceral, and Transplantation Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria-Theresia-Klinik
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Hölscher, MD
Phone
0049/89/7207325
Email
dr.hoelscher@maria-theresia-klinik.de
First Name & Middle Initial & Last Name & Degree
Carolin Orlitsch, MD
Phone
0049/89/7207325
Email
dr.orlitsch@maria-theresia-klinik.de
Facility Name
Krankenhaus Barmherzige Brüder München
City
München
State/Province
Bayern
ZIP/Postal Code
80639
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johann Spatz, MD
Phone
0049/89/17972302
Email
johann.spatz@barmherzige-muenchen.de
Facility Name
Klinikum der Universität München
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Rentsch, MD
Phone
0049/89/4400/711213
Email
markus.rentsch@med.uni-muenchen.de
First Name & Middle Initial & Last Name & Degree
Sandro M Hasenhütl, MD
Phone
0049/89/4400/711242
Email
sandro.hasenhuetl@med.uni-muenchen.de

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to third parties beyond the study team.

Learn more about this trial

Transverse Coloplasty vs. Side-to-end Anastomosis Following Low Anterior Resection (LAR): CSAR Trial

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