CClinicalTrials.gg
CompletedNCT04223141Updated May 6, 2026

Single-stapled Double Purse-string Technique for Colorectal Anastomosis

An interventional study of SIA in Colo-rectal Cancer, sponsored by Vejle Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Vejle Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colo-rectal Cancer

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Keywords

  • Robot
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 39 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Vejle Hospital is the lead sponsor of 93 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Verified cancer of the sigmoid colon
  • Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis
  • Operation with curative intent

Exclusion criteria

Exclusion Criteria:

  • Not legally competent and/or \< 18 years old
  • Not able to comprehend information and/or give written consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Study group

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

    Procedure: SIA

Interventions

  • ProcedureSIA

    As indicated by arm description

06

What researchers measure

Primary outcomes

  1. Technical success

    Successful construction of anastomosis by double purse-string technique

    Time frame: 30 days

  2. Complications

    Surgical complications graded by Clavien-Dindo

    Time frame: 30 days

  3. Mortality

    Postoperative death

    Time frame: 30 days

Secondary outcomes

  1. LOS

    Length of stay - number of days from day of operation to discharge

    Time frame: 90 days

  2. Readmissions

    Unplanned hospital admissions at least 24 hs after discharge

    Time frame: 30 days

  3. Operation time

    Duration of operation from incision to last skin stitch

    Time frame: 30 days

  4. Blood loss

    Estimated intraoperative blood loss in ml

    Time frame: 30 days

  5. Medical complications

    Medical complications graded by Clavien-Dindo and MESS

    Time frame: 30 days

07

Study locations

1 site
  • Vejle Hospital, Department of Surgery
    Vejle, DK7100, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04223141
Lead sponsor
Vejle Hospital
Responsible party
Sponsor
First posted
Jan 10, 2020
Start date
Mar 17, 2020
Primary completion
Dec 31, 2022
Completion
Dec 31, 2025
Last update
May 6, 2026

Study contacts

Helene J Würtz, MD
principal investigator · Staff Surgeon
Flemming H Dall, MD PhD
principal investigator · Consultant
Hans B Rahr, MD DMSc
study director · Department Head

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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