NCT04223141

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 17, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

January 7, 2020

Last Update Submit

April 29, 2026

Conditions

Colo-rectal Cancer

Keywords

Robot

Outcome Measures

Primary Outcomes (3)

  • Technical success

    Successful construction of anastomosis by double purse-string technique

    30 days

  • Complications

    Surgical complications graded by Clavien-Dindo

    30 days

  • Mortality

    Postoperative death

    30 days

Secondary Outcomes (5)

  • LOS

    90 days

  • Readmissions

    30 days

  • Operation time

    30 days

  • Blood loss

    30 days

  • Medical complications

    30 days

Study Arms (1)

Study group

EXPERIMENTAL

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

Procedure: SIA

Interventions

SIAPROCEDURE

As indicated by arm description

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vejle Hospital, Department of Surgery

Vejle, DK7100, Denmark

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Helene J Würtz, MD

    Staff Surgeon

    PRINCIPAL INVESTIGATOR

  • Flemming H Dall, MD PhD

    Consultant

    PRINCIPAL INVESTIGATOR

  • Hans B Rahr, MD DMSc

    Department Head

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 10, 2020

Study Start

March 17, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)