Single-stapled Double Purse-string Technique for Colorect... | NCT04223141

Studies
Single-stapled Double Purse-string Technique for Colorectal Anastomosis

NCT04223141

Sponsor

Vejle Hospital

Status

Completed

Last Update Posted

May 6, 2026Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Colo-rectal Cancer

Interventions

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

Jan 7, 2020

First Submission Date that Met QC Criteria

Jan 7, 2020

First Posted Date

Jan 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

May 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Robot-assisted laparoscopic resection of sigmoid colon with colorectal anastomosis constructed by the double purse-string technique	Procedure: SIA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SIA	Procedure	As indicated by arm description	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
LOS	Length of stay - number of days from day of operation to discharge	90 days
Readmissions	Unplanned hospital admissions at least 24 hs after discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vejle Hospital, Department of Surgery		Vejle		DK7100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided