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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
As indicated by arm description
Vejle Hospital, Department of Surgery
Vejle, Denmark
Technical success
Successful construction of anastomosis by double purse-string technique
Time frame: 30 days
Complications
Surgical complications graded by Clavien-Dindo
Time frame: 30 days
Mortality
Postoperative death
Time frame: 30 days
LOS
Length of stay - number of days from day of operation to discharge
Time frame: 90 days
Readmissions
Unplanned hospital admissions at least 24 hs after discharge
Time frame: 30 days
Operation time
Duration of operation from incision to last skin stitch
Time frame: 30 days
Blood loss
Estimated intraoperative blood loss in ml
Time frame: 30 days
Medical complications
Medical complications graded by Clavien-Dindo and MESS
Time frame: 30 days
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