Single-stapled Double Purse-string Technique for Colorectal Anastomosis

April 23, 2024 updated by: Vejle Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Vejle, Denmark, DK7100
        • Vejle Hospital, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Robot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique
Procedure: SIA
As indicated by arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: 30 days
Successful construction of anastomosis by double purse-string technique
30 days
Complications
Time Frame: 30 days
Surgical complications graded by Clavien-Dindo
30 days
Mortality
Time Frame: 30 days
Postoperative death
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LOS
Time Frame: 90 days
Length of stay - number of days from day of operation to discharge
90 days
Readmissions
Time Frame: 30 days
Unplanned hospital admissions at least 24 hs after discharge
30 days
Operation time
Time Frame: 30 days
Duration of operation from incision to last skin stitch
30 days
Blood loss
Time Frame: 30 days
Estimated intraoperative blood loss in ml
30 days
Medical complications
Time Frame: 30 days
Medical complications graded by Clavien-Dindo and MESS
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Principal Investigator: Helene J Würtz, MD, Staff Surgeon
  • Principal Investigator: Flemming H Dall, MD PhD, Consultant
  • Study Director: Hans B Rahr, MD DMSc, Department Head

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIA2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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