Back to resultsSingle-stapled Double Purse-string Technique for Colorectal Anastomosis
Primary Purpose
Colo-rectal Cancer
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
SIA
Sponsored by
About this trial
This is an interventional treatment trial for Colo-rectal Cancer focused on measuring Robot
Eligibility Criteria
Inclusion Criteria (all must be fulfilled):
- Verified cancer of the sigmoid colon
- Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis
- Operation with curative intent
Exclusion Criteria:
- Not legally competent and/or < 18 years old
- Not able to comprehend information and/or give written consent
Sites / Locations
- Vejle Hospital, Department of Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
Robot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique
Outcomes
Primary Outcome Measures
Technical success
Successful construction of anastomosis by double purse-string technique
Complications
Surgical complications graded by Clavien-Dindo
Mortality
Postoperative death
Secondary Outcome Measures
LOS
Length of stay - number of days from day of operation to discharge
Readmissions
Unplanned hospital admissions at least 24 hs after discharge
Operation time
Duration of operation from incision to last skin stitch
Blood loss
Estimated intraoperative blood loss in ml
Medical complications
Medical complications graded by Clavien-Dindo and MESS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04223141
Brief Title
Single-stapled Double Purse-string Technique for Colorectal Anastomosis
Official Title
Single-stapled Double Purse-string Anastomotic (SIA) Technique in Robotic Malignant Sigmoid Resections
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 17, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.
Detailed Description
In all, 30 consecutive patients will be enrolled. The first 5 will be regarded as a pilot series for testing and aligning the study setup. The next 25 patients will form the study group. The clinical outcomes will be compared with historical control patients from our own department. Safety and feasibility will be assessed by short-term clinical outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer
Keywords
Robot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Robot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique
Intervention Type
Procedure
Intervention Name(s)
SIA
Intervention Description
As indicated by arm description
Primary Outcome Measure Information:
Title
Technical success
Description
Successful construction of anastomosis by double purse-string technique
Time Frame
30 days
Title
Complications
Description
Surgical complications graded by Clavien-Dindo
Time Frame
30 days
Title
Mortality
Description
Postoperative death
Time Frame
30 days
Secondary Outcome Measure Information:
Title
LOS
Description
Length of stay - number of days from day of operation to discharge
Time Frame
90 days
Title
Readmissions
Description
Unplanned hospital admissions at least 24 hs after discharge
Time Frame
30 days
Title
Operation time
Description
Duration of operation from incision to last skin stitch
Time Frame
30 days
Title
Blood loss
Description
Estimated intraoperative blood loss in ml
Time Frame
30 days
Title
Medical complications
Description
Medical complications graded by Clavien-Dindo and MESS
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (all must be fulfilled):
Verified cancer of the sigmoid colon
Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis
Operation with curative intent
Exclusion Criteria:
Not legally competent and/or < 18 years old
Not able to comprehend information and/or give written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene J Würtz, MD
Organizational Affiliation
Staff Surgeon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flemming H Dall, MD PhD
Organizational Affiliation
Consultant
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans B Rahr, MD DMSc
Organizational Affiliation
Department Head
Official's Role
Study Director
Facility Information:
Facility Name
Vejle Hospital, Department of Surgery
City
Vejle
ZIP/Postal Code
DK7100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single-stapled Double Purse-string Technique for Colorectal Anastomosis
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