Single-stapled Double Purse-string Technique for Colorectal Anastomosis

Vejle Hospital

Status: Active, not recruiting

Conditions: Colo-rectal Cancer

Treatments: Procedure: SIA

Study type: Interventional

Funder types: Other

Identifiers

NCT04223141

SIA2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Study group

Experimental group

Description:

Robot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique

Treatment:

Procedure: SIA