Single-stapled Double Purse-string Technique for Colorectal Anastomosis

Colo-rectal Cancer Clinical Trial

Official title:

Single-stapled Double Purse-string Anastomotic (SIA) Technique in Robotic Malignant Sigmoid Resections

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04223141
• Other study ID #: SIA2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 17, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• SIA
As indicated by arm description

Locations

Country	Name	City	State
Denmark	Vejle Hospital, Department of Surgery	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Successful construction of anastomosis by double purse-string technique	30 days
Primary	Complications	Surgical complications graded by Clavien-Dindo	30 days
Primary	Mortality	Postoperative death	30 days
Secondary	LOS	Length of stay - number of days from day of operation to discharge	90 days
Secondary	Readmissions	Unplanned hospital admissions at least 24 hs after discharge	30 days
Secondary	Operation time	Duration of operation from incision to last skin stitch	30 days
Secondary	Blood loss	Estimated intraoperative blood loss in ml	30 days
Secondary	Medical complications	Medical complications graded by Clavien-Dindo and MESS	30 days